Arrayed sharp spike membrane piercing target drug loaded sandwich balloon

Abstract

The application relates to the technical field of medical devices, and provides an array sharp membrane-breaking target drug-loading sandwich balloon, which comprises a catheter and a balloon body fixed to the distal end of the catheter, the catheter is provided with a guide wire inlet and a pressure inlet, the balloon body comprises an inner balloon body and an outer balloon body, a pressure cavity in communication with the pressure inlet is formed in the inner balloon body, a drug storage isolation cavity is formed between the inner balloon body and the outer balloon body, and therapeutic drugs are preloaded in the drug storage isolation cavity; the outer surface of the outer balloon body is provided with arrayed puncture sharp spikes, the tip of each sharp spike is provided with a gel-sealed micropore puncture head, and a drug release channel is formed in the sharp spike and leads to the micropore puncture head. After the balloon is delivered to a lesion site and is inflated under pressure, the sharp spikes pierce the plaque fiber layer and anchor the blood vessel wall, when the pressure reaches a preset threshold value, the gel seal falls off or dissolves, and the drug solution is released to the lesion tissue in a targeted manner through the internal channel of the sharp spike. The array sharp membrane-breaking target drug-loading sandwich balloon integrates membrane breaking, anchoring and targeted drug delivery, and significantly improves the drug permeation rate and the operation stability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an array of spiked membrane-perforating targeted drug-loaded sandwich balloon. Background Technology

[0002] Percutaneous coronary intervention (PCI) is currently the main method for treating coronary artery and peripheral vascular plaque stenosis. In recent years, drug-coated balloons (DCBs), as an "interventional without implantation" treatment, have been widely used in clinical practice. By coating the surface of the balloon with anti-proliferative drugs, the drugs are transferred to the vessel wall during balloon inflation, thereby inhibiting intimal hyperplasia and reducing the incidence of restenosis.

[0003] However, existing drug-eluting balloons still have the following technical drawbacks: First, they have limited drug loading capacity and low drug delivery efficiency. Most existing drug-eluting balloons use a surface coating method, where the drug only adheres to the outer surface of the balloon. The amount of drug loaded per charge is limited by the balloon's surface area, making it difficult to meet the dosage requirements of the lesion site. More importantly, the surface of vascular plaques is usually covered with a dense fibrous cap. This fibrous layer has a dense structure and poor permeability, severely hindering the penetration of the balloon surface drug into the deeper plaque and the vascular media. This results in a large amount of drug remaining on the vascular surface and being washed away by blood flow, leaving a very limited amount of drug actually reaching the target lesion, significantly reducing the therapeutic effect. Second, balloons are prone to slippage and displacement during dilation. During balloon dilation, due to the smooth or calcified surface of the vascular plaque, the balloon is prone to slippage and displacement along the axial or circumferential direction of the vessel during inflation. This not only affects the accuracy of dilation positioning but may also cause additional damage to the vascular intima due to repeated adjustments to the balloon's position. This problem is particularly prominent in eccentric plaques or severely calcified lesions. Third, there is a lack of a quantitatively controllable drug release mechanism. Traditional drug-eluting balloons mainly rely on the contact friction between the coating and the blood vessel wall during balloon dilation, which is a passive and rapid release method. It is difficult to achieve quantitative and controllable drug release at the lesion site, and the drug action time is short, which cannot meet the treatment needs of long-term inhibition of restenosis. Summary of the Invention

[0004] Therefore, the present invention aims to solve the problems of existing drug-eluting balloons, such as limited drug loading capacity of the surface coating, impeded drug penetration by the fibrous barrier on the surface of the plaque, easy slippage and displacement of the balloon in the blood vessel during expansion, and lack of quantitative and controllable drug release mechanism, resulting in low drug delivery efficiency at the lesion site, poor surgical positioning stability, and difficulty in achieving long-term targeted therapy. Thus, the present invention provides an array of spikes perforating membrane-targeting drug-eluting splint balloon.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: This invention provides an array of spiked membrane-perforating targeted drug-loaded splint balloon, comprising a catheter and a balloon body fixed to the distal end of the catheter. The catheter has a guidewire inlet and a pressure inlet. The balloon body includes an inner balloon and an outer balloon. The space between the inner balloon and the catheter forms a pressure chamber, which communicates with the pressure inlet. The space between the inner balloon and the outer balloon forms a drug-retention cavity, which is pre-loaded with a therapeutic drug. The outer surface of the outer balloon is provided with an array of puncture spikes. The puncture needle is equipped with a microporous puncture head at its tip, and a drug release channel extending through the microporous puncture head is formed inside the puncture needle. The microporous puncture head is sealed with a soluble or ruptureable gel material. When the pressure inside the pressure chamber reaches a preset pressure threshold, the pressure chamber expands and squeezes the drug storage isolation chamber, increasing the pressure inside the drug storage isolation chamber and forcing the gel material sealing the microporous puncture head to detach or dissolve. The drug solution in the drug storage isolation chamber is then released outward through the drug release channel and the microporous puncture head.

[0006] Furthermore, the inner capsule is more resilient than the outer capsule.

[0007] Furthermore, the puncture needle and the outer capsule are integrally formed from the same material.

[0008] Furthermore, the puncture needle can pierce the dense fibrous layer on the surface of the vascular plaque and simultaneously anchor to the vascular wall during balloon dilation to prevent balloon slippage during the procedure.

[0009] Furthermore, the height of the puncture tip is 200μm to 800μm; the outer diameter of the microporous puncture head is 50μm to 200μm.

[0010] Furthermore, the puncture needles are evenly distributed in an array along the axial and circumferential directions on the outer surface of the outer capsule; the axial distance between adjacent needles is 1 mm to 5 mm; the circumferential distance between adjacent needles is 1 mm to 5 mm.

[0011] Furthermore, the inner diameter of the drug release channel gradually decreases along the direction close to the micro-perforated puncture head.

[0012] Furthermore, the gel material is a water-soluble gel or a pressure-sensitive gel, and the gel material ruptures or dissolves when the pressure inside the drug storage isolation cavity reaches the preset pressure threshold, thereby opening the microporous puncture head.

[0013] Furthermore, the drug storage isolation cavity is continuously arranged around the circumference of the balloon body.

[0014] Furthermore, the distal and proximal ends of the inner capsule are respectively sealed to the distal and proximal ends of the outer capsule.

[0015] The technical solution of this invention has the following advantages: The array-spike-based targeted drug-loaded splint balloon provided by this invention features an array of puncture spikes on the outer surface of the outer balloon. During balloon expansion, these spikes first puncture the dense fibrous cap barrier of the plaque surface, forming controllable microchannels on the plaque surface, thereby opening the permeation pathway for drugs to penetrate deeper into the plaque and the vascular media. Simultaneously, the drug solution within the storage chamber is released directionally to the puncture site through drug release channels and microporous puncture heads inside the spikes under pressure, achieving targeted and deep drug delivery to the lesion tissue. Compared to traditional drug-coated balloons that rely on passive drug delivery via surface contact friction, this invention effectively avoids the obstruction of the fibrous barrier to drug penetration, significantly increasing the drug retention concentration and penetration depth in the diseased tissue.

[0016] The array-spiked, membrane-perforating, drug-loaded dissecting balloon provided by this invention features arrayed puncture spikes that penetrate the plaque tissue and even the superficial intima of the blood vessel wall during balloon inflation, forming a multi-point anchoring force that firmly fixes the balloon to the target lesion site. Even in complex situations such as eccentric plaques, calcified lesions, or vascular pulsation, the balloon maintains a stable spatial position during expansion and drug release, avoiding the problems of positioning inaccuracies, repeated adjustments, and additional damage to the vascular intima caused by slippage and displacement of traditional balloons, significantly improving the precision and safety of surgical procedures.

[0017] The array-spike membrane-perforating targeted drug-loaded splint balloon provided by this invention abandons the traditional balloon drug delivery method that relies on surface coatings. Instead, it uses an annular space between the inner and outer balloon bodies as an independent drug-reservoir, with an internal volume much larger than the drug-load capacity of the balloon surface coating. This greater drug load not only provides ample drug reserves for the lesion site but also allows for the selection of long-acting sustained-release formulations according to clinical needs, providing a material basis for improving long-term vascular patency after surgery.

[0018] The array-spiked membrane-perforating targeted drug-loaded splint balloon provided by this invention uses a gel material to seal the microporous puncture head. The expansion pressure of the pressure chamber indirectly drives the pressure inside the drug-storage isolation chamber to rise. Only when a preset pressure threshold is reached does the gel material rupture or dissolve, opening the microporous release channel. This mechanism establishes a quantitative triggering relationship between drug release and balloon expansion pressure, initiating release only when the pressure chamber reaches the set pressure, and the release rate is correlated with the continuous pressurization of the pressure chamber. Compared to traditional drug-loaded balloons that rapidly release all drugs upon expansion, this invention achieves controllable and quantitative drug release, which helps maintain an effective drug concentration at the lesion site and better inhibits postoperative restenosis.

[0019] The array-spiked, targeted drug-eluting splint balloon provided by this invention simultaneously achieves three functions with a single instrument: plaque fibrous layer perforation pretreatment, balloon expansion and anchoring, and targeted and controllable drug delivery. This eliminates the need for intraoperative instrument changes or step-by-step procedures; the entire treatment process requires only one balloon delivery, positioning, and pressurization. This not only shortens the operation time and reduces the risks associated with intraoperative instrument exchanges, but also allows this technology to be easily adapted to existing interventional surgical procedures, lowering the learning curve and usage threshold for physicians. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the array-spike membrane-perforating targeted drug-loaded interlayer balloon provided in an embodiment of the present invention; Figure 2 This is a schematic diagram of the axial cross-sectional structure of the array-pointed perforated membrane-targeting drug-loaded sandwich balloon provided in an embodiment of the present invention; Figure 3 yes Figure 2 A magnified schematic diagram of a local structure; Figure 4 This is a schematic diagram showing the positional relationship between the guidewire cavity, pressure cavity, and drug storage isolation cavity in the array-spike membrane-perforating targeted drug-loaded interlayer balloon provided in an embodiment of the present invention; Figure 5 This is an enlarged schematic diagram of the balloon body in the array-spike membrane-perforating targeted drug-loaded interlayer balloon provided in an embodiment of the present invention.

[0022] Explanation of reference numerals in the attached figures: 1. Catheter; 101. Guidewire inlet; 102. Pressure inlet; 103. Catheter seat; 104. Distal end of catheter; 105. Guidewire lumen; 106. Gas chamber; 2. Balloon body; 201. Inner capsule; 202. Outer capsule; 203. Pressure chamber; 204. Drug storage and isolation chamber; 2041. Therapeutic drug; 205. Puncture needle; 2051. Micro-perforated puncture head; 2052. Drug release channel; 2053. Gel material. Detailed Implementation

[0023] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0025] In the description of this invention, it should be noted that, unless otherwise explicitly specified and defined, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0026] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0027] Example 1 like Figures 1 to 5 As shown, this embodiment provides an array of thorn-shaped membrane-perforating targeted drug-eluting dissecting balloon. This balloon is mainly used in the field of percutaneous coronary intervention (PCI) for dilation, pretreatment, and targeted drug delivery of plaque stenosis lesions in the coronary arteries and peripheral vessels to inhibit postoperative restenosis.

[0028] Please refer to Figure 1 and Figure 2The array-spike membrane-perforating targeted drug-loaded splint balloon mainly comprises a catheter 1 and a balloon body 2 fixed to the distal end 104 of the catheter. The catheter 1 is a multi-lumen medical catheter with a catheter seat 103 connected to its proximal end. The catheter seat 103 has a guidewire inlet 101 and a pressure inlet 102. The interior of the catheter 1 has a guidewire lumen 105 and a gas chamber 106 arranged axially and isolated from each other. The guidewire inlet 101 communicates with the guidewire lumen 105 for the guidewire to pass through, enabling balloon delivery and positioning. The pressure inlet 102 communicates with the gas chamber 106 for filling the balloon with a pressurized medium such as gas or liquid.

[0029] like Figure 2 and Figure 4 As shown, the balloon body 2 is the core component of this invention for realizing the functions of expansion, anchoring, and drug delivery. It has an overall sac-like structure that contracts at both ends and expands in the middle. Specifically, the balloon body 2 includes an inner sac 201 and an outer sac 202, both of which are thin film sacs made of polymer materials.

[0030] Structurally, the inner capsule 201 is fitted around the distal end 104 of the catheter 1. An annular interlayer space is formed between the inner wall of the inner capsule 201 and the outer wall of the catheter 1, constituting the pressure chamber 203 of the balloon. The proximal end of the pressure chamber 203 communicates with the distal end of the gas chamber 106, and further communicates with the pressure inlet 102. When an operator injects gas or liquid media into the pressure chamber 203 through the pressure inlet 102 and the gas chamber 106, the pressure within the pressure chamber 203 increases, driving the inner capsule 201 and the outer capsule 202 to expand outwards synchronously.

[0031] The outer capsule 202 is fitted over the inner capsule 201. An annular interlayer space is formed between the outer wall of the inner capsule 201 and the inner wall of the outer capsule 202, constituting the drug-filled isolation cavity 204 of the balloon. The drug-filled isolation cavity 204 is an independent, sealed annular cavity pre-filled with a certain volume of therapeutic drug 2041. This therapeutic drug 2041 is preferably an anti-angiogenic drug, an anti-stenosis thrombolytic drug, or a combination thereof, such as paclitaxel, rapamycin, and their derivatives, to inhibit excessive proliferation of vascular smooth muscle cells, thereby reducing the incidence of restenosis after surgery.

[0032] To ensure the independence and airtightness of each chamber, the proximal and distal ends of the inner capsule 201 are sealed to the proximal and distal ends of the outer capsule 202 by means of heat sealing, laser welding, or bonding. Simultaneously, the proximal and distal ends of the inner capsule 201 are also sealed and fixed to the outer wall of the catheter 1, thereby completely isolating the pressure chamber 203 and the drug storage isolation chamber 204, ensuring that the pressure medium and the therapeutic drug 2041 do not leak from each other.

[0033] like Figure 1 and Figure 5 As shown, the outer surface of the outer capsule 202 is provided with an array of puncture spikes 205. Each puncture spike 205 is a micron-sized protrusion, generally conical or pyramidal in shape, with its tip pointing radially outward from the outer capsule 202. The puncture spikes 205 are uniformly distributed in an array along the axial and circumferential directions on the outer surface of the outer capsule 202, forming a multi-point array structure. The axial spacing between adjacent spikes is preferably 1 mm to 5 mm, and the circumferential spacing between adjacent spikes is preferably 1 mm to 5 mm. This arrangement ensures uniform puncture of the plaque fiber layer while providing sufficient anchoring force to prevent axial or circumferential slippage of the balloon during expansion.

[0034] The puncture spike 205 and the outer capsule 202 are preferably integrally formed from the same polymer material through processes such as injection molding, hot pressing, or 3D printing. This integrally formed structure not only simplifies the manufacturing process and reduces production costs, but more importantly, it ensures the connection strength between the puncture spike 205 and the outer capsule 202, effectively avoiding the risk of spike detachment during high-pressure expansion or puncturing hard plaques, thus improving product reliability and safety. In this embodiment, the outer capsule 202 can be made of a material with relatively low toughness, such as nylon, polyethylene terephthalate (PET), or polyamide elastomer, to ensure that it can deform and transmit pressure under external force. The inner capsule 201 is preferably made of a material with higher toughness than the outer capsule 202, such as polyurethane or polyether block amide (PEBAX), making the expansion deformation capacity of the inner capsule greater than that of the outer capsule, and ensuring good rupture resistance and deformation recovery ability when subjected to high internal pressure.

[0035] Please refer to further details. Figure 3 , Figure 3 yes Figure 2 A magnified schematic diagram of a portion of the central balloon body 2, used to clearly demonstrate the fine structure of a single puncture tip 205. (See attached image.) Figure 3As shown, a microporous puncture head 2051 is provided at the tip of the puncture needle 205, that is, at its most distal apex. The microporous puncture head 2051 is a tiny opening structure, with an outer diameter preferably between 50 μm and 200 μm. Simultaneously, a drug release channel 2052 is formed axially inside the puncture needle 205, extending to the microporous puncture head 2051. The drug release channel 2052 is the only pathway for the drug solution to flow from the drug storage isolation chamber 204 to the microporous puncture head 2051 and ultimately be released to the lesion site.

[0036] To achieve precise control over drug release, the microporous puncture head 2051 is initially sealed with a soluble or ruptureable gel material 2053. The gel material 2053 can be a water-soluble gel, such as polyvinyl alcohol (PVA) gel, gelatin, or cellulose derivative gel; or it can be a pressure-sensitive gel, i.e., a gel material that can rupture or deform under certain pressure to open the channel. The gel material 2053 is filled or covered at the microporous puncture head 2051 by methods such as dripping, impregnation, or in-situ polymerization to temporarily seal the outlet of the drug release channel 2052.

[0037] The working process and principle of the array-spiked membrane-perforating targeted drug-loaded interlayer balloon of this embodiment will be described in detail below.

[0038] First, during the preoperative preparation stage, the guidewire is inserted into the guidewire lumen 105 of the catheter 1 through the guidewire inlet 101, and with the guidance of the guidewire, the balloon body 2 is precisely delivered along the vascular path to the target lesion site, namely the plaque stenosis lesion of the blood vessel.

[0039] Subsequently, a pressure medium, such as saline or contrast agent, is slowly injected into the pressure chamber 203 through the pressure inlet 102 and the gas chamber 106, gradually increasing the pressure within the pressure chamber 203. Due to the high toughness of the inner capsule 201, it can withstand high pressure without rupture, and the pressure medium drives the entire balloon body 2 to expand radially outward. In the initial stage of expansion, the puncture tips 205 on the outer surface of the outer capsule 202 gradually approach and eventually contact the vessel wall as the balloon expands. As the pressure continues to rise, the arrayed puncture tips 205 penetrate the plaque surface, first piercing the dense fibrous layer covering the plaque surface, forming numerous tiny channels on the fibrous layer, thereby removing the fibrous barrier's obstruction of subsequent drug penetration. Simultaneously, multiple puncture tips 205 simultaneously penetrate the superficial intima of the vessel wall or the interior of the plaque tissue, forming a multi-point anchoring force. This multi-point anchoring structure can firmly fix the balloon in place at the lesion site, effectively preventing the balloon from slipping and shifting during subsequent dilation due to vascular pulsation or insufficient surface friction, thus significantly improving the stability and positioning accuracy of the surgical procedure.

[0040] Furthermore, when the operator continues to pressurize the pressure chamber 203, causing the pressure inside the pressure chamber 203 to reach a preset pressure threshold, such as 6 atm to 12 atm, the targeted drug delivery function of the present invention is triggered. Specifically, since the pressure chamber 203 is located in the innermost layer, a further increase in its internal pressure will force the highly resilient inner capsule 201 to expand outward and compress the adjacent drug storage isolation chamber 204. The drug storage isolation chamber 204 is a closed volumetric cavity. After being compressed by the inner capsule 201, its internal volume decreases, thereby causing a sharp increase in the pressure of the pre-filled drug solution inside the drug storage isolation chamber 204.

[0041] When the pressure inside the drug-storage isolation chamber 204 reaches a level sufficient to destroy the structural integrity of the gel material 2053, the gel material 2053 sealing the microporous puncture head 2051 will undergo physical rupture or chemical dissolution. For water-soluble gels, they will gradually dissolve under the influence of high-pressure drug solution and body fluid environment, thus losing their sealing effect. For pressure-sensitive gels, they will undergo brittle fracture or deformation failure when a preset pressure threshold is reached, thereby opening the outlet of the drug release channel 2052. Once the gel material 2053 detaches or dissolves, the microporous puncture head 2051 is opened, and the high-pressure drug solution inside the drug-storage isolation chamber 204 will rapidly enter the drug release channel 2052 inside the puncture tip 205 under the combined action of pressure difference and balloon compression, and will finally be precisely sprayed or penetrated through the microporous puncture head 2051 into the plaque tissue and deep layers of the blood vessel wall that the tip has punctured beforehand.

[0042] During this process, as the inner diameter of the drug release channel 2052 gradually decreases along the direction approaching the microporous puncture head 2051, this nozzle-like structural design significantly increases the flow rate and impact force of the drug solution at the microporous puncture head 2051, helping the drug solution to penetrate plaque tissue more deeply and achieve targeted deep drug delivery. Simultaneously, since the initiation of drug release strictly depends on whether the pressure chamber 203 reaches a preset pressure threshold, the operator can precisely control the timing and dosage of drug release by controlling the pressure applied by the external pressurization device. When the pressure in the pressure chamber 203 is maintained above the threshold, the gel material 2053 is in an open state, allowing the drug solution in the drug storage isolation chamber 204 to be continuously released. When it is necessary to stop drug administration, simply perform a pressure relief operation through the pressure inlet 102. The pressure chamber 203 contracts, the squeezing force on the drug storage isolation chamber 204 disappears, and the pressure inside the drug storage isolation chamber 204 also decreases. However, at this time, since the gel material has ruptured or dissolved, the drug release channel 2052 is in a permanently open state. The remaining drug solution in the drug storage isolation chamber 204 may continue to slowly seep out before the balloon is withdrawn. However, this does not affect the clinical efficacy of the present invention, because under the target pressure, most of the effective drug solution has already been targeted and released at the lesion site.

[0043] Finally, after the procedure is completed and adequate medication is confirmed, the operator extracts the pressure medium from the pressure chamber 203 through the pressure inlet 102, achieving complete depressurization and contraction of the balloon. At this point, the puncture tip 205 withdraws from the blood vessel wall, the balloon body 2 returns to its initial small diameter state, and then the entire balloon, along with the catheter 1, is withdrawn from the patient's body, completing the entire interventional treatment procedure.

[0044] Example 2 This embodiment further optimizes the structural dimensions of the puncture tip 205 in Embodiment 1. Based on the above technical solution, this embodiment specifically limits the height of the puncture tip 205 and the outer diameter of the microporous puncture head 2051. In practical applications, the thickness of the blood vessel wall and the thickness of the plaque fibrous layer are usually within a certain range. If the height of the puncture tip 205 is too small, for example, less than 200 μm, it may not be able to completely pierce the dense fibrous cap tissue, resulting in the drug release channel 2052 not being able to effectively connect to the deep part of the plaque, affecting the drug penetration effect. Conversely, if the height is too large, for example, greater than 800 μm, it may cause the tip to penetrate the entire thickness of the blood vessel wall, causing serious complications such as vascular perforation. Therefore, limiting the height of the puncture tip 205 to 200 μm to 800 μm ensures both effective piercing of the fibrous layer and the safety of the operation. Similarly, the outer diameter of the micro-perforated puncture head 2051 is limited to 50μm to 200μm. This size ensures that the drug solution is released at a certain flow rate, without forming an excessively large wound on the blood vessel wall due to an excessively large orifice.

[0045] Example 3 This embodiment is a further optimization of the structure of the drug release channel 2052 in Example 1. For example... Figure 3 As shown, in this embodiment, the drug release channel 2052 inside the puncture tip 205 is not a channel of constant diameter, but rather its inner diameter gradually decreases along the direction close to the microporous puncture head 2051. This variable diameter structure, especially the constriction section design similar to a "Laval tube," can convert the pressure potential energy of the drug solution into kinetic energy when the solution flows through this section, thereby significantly increasing the spray velocity of the drug solution at the microporous puncture head 2051. This high-speed jet helps the drug solution overcome the tissue resistance deep within the plaque, achieving deeper penetration over greater distances and wider areas, further improving the uniformity of drug distribution and the depth of infiltration in the diseased tissue.

[0046] Example 4 This embodiment provides a specific selection of the gel material 2053. The gel material 2053 is preferably a water-soluble gel or a pressure-sensitive gel. When a water-soluble gel comes into contact with body fluids or high-pressure medication, it gradually absorbs water, swells, and dissolves; its dissolution rate can be controlled by selecting different gel components and degrees of cross-linking. Pressure-sensitive gels, on the other hand, have the characteristic of structural rupture when a specific pressure value is reached. Both of these material selections can precisely achieve the core function of "pressure threshold triggering," meaning that before the pressure in the pressure chamber 203 reaches a preset threshold, the gel material 2053 remains intact, ensuring the sealing of the drug storage isolation chamber 204 and preventing premature leakage of the medication. Only when the preset pressure threshold is reached will the gel material 2053 open its channels due to physical rupture or chemical dissolution, thereby achieving quantitative and controllable pulsed drug delivery.

[0047] Example 5 This embodiment mainly describes the structure and sealing method of the drug storage isolation cavity 204. For example... Figure 4 As shown, the drug-storage isolation cavity 204 is continuously arranged around the circumference of the balloon body 2, forming a complete annular cavity. This circumferential design ensures that when the balloon body 2 expands at any angle in the circumference, the drug-storage isolation cavity 204 can uniformly supply drug solution to the puncture tips 205 at each position, ensuring the uniformity of circumferential drug delivery. Simultaneously, to ensure the absolute sealing of the drug-storage isolation cavity 204, the distal and proximal ends of the inner capsule 201 are seamlessly connected to the distal and proximal ends of the outer capsule 202, respectively. This connection method can be thermoforming welding, ultrasonic welding, or bonding with medical-grade adhesive. The sealed connection not only ensures that the drug solution will not leak during storage and transportation, but also ensures that all pressure is effectively applied to the drug solution during the compression process of the pressure chamber 203, without pressure loss due to leakage at the connection, thereby ensuring that the gel material 2053 can be triggered on time and reliably.

[0048] In summary, the working principle of the array-spike membrane-perforating targeted drug-loaded interlayer balloon of the present invention can be summarized as a three-step synergistic process: Step 1: Expansion and Pretreatment. The balloon body 2 is expanded by the pressure chamber 203, which causes the array of puncture spikes 205 on the surface of the outer balloon body 202 to contact and puncture the dense fibrous layer of the plaque surface, physically opening the drug penetration channel. At the same time, it provides multi-point anchoring for the balloon to prevent slippage.

[0049] Step 2: Pressure triggering. When the pressure in the pressure chamber 203 rises to a preset threshold (e.g., 6-12 atm), the further expansion of the pressure chamber 203 effectively compresses the drug storage isolation chamber 204, causing the internal pressure of the drug storage isolation chamber 204 to rise sharply.

[0050] Step 3: Targeted Release. Increased pressure acts on the gel material 2053 sealing the microporous puncture head 2051, causing it to rupture or dissolve, thereby opening the drug release channel 2052. Under the pressure difference and squeezing force, the high-pressure drug solution in the drug storage isolation chamber 204 is precisely released from the microporous puncture head 2051 through the drug release channel 2052 inside the puncture tip 205, ultimately reaching the deep lesion tissue pre-penetrated by the tip, achieving targeted drug delivery.

[0051] Through the above process, this invention simultaneously completes the three functions of plaque membrane rupture pretreatment, balloon dilation and anchoring, and targeted and controllable drug delivery with a single instrument and a single operation, effectively solving the technical problems of low drug loading, poor drug penetration, easy slippage during operation, and uncontrollable drug release of traditional drug balloons.

[0052] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to cover all possible implementations. Those skilled in the art will recognize that various variations and modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations and modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A targeted drug-loaded splint balloon with arrayed spikes, comprising a catheter (1) and a balloon body (2) fixed to the distal end (104) of the catheter, wherein the catheter (1) has a guidewire inlet (101) and a pressure inlet (102), characterized in that: The balloon body (2) includes an inner balloon (201) and an outer balloon (202); the interlayer space between the inner balloon (201) and the catheter (1) forms a pressure chamber (203), which is connected to the pressure inlet (102); the interlayer space between the inner balloon (201) and the outer balloon (202) forms a drug storage isolation chamber (204), which is pre-filled with a therapeutic drug (2041); the outer surface of the outer balloon (202) is provided with arrayed puncture needles (205), the tip of each puncture needle (205) is provided with a micro-perforated puncture head (2051), and a drug release channel (2052) is opened inside the puncture needle (205) to the micro-perforated puncture head (2051). The micro-perforation puncture head (2051) is sealed with a soluble or ruptureable gel material (2053); When the pressure inside the pressure chamber (203) reaches the preset pressure threshold, the pressure chamber (203) expands and squeezes the drug storage isolation chamber (204), increasing the pressure inside the drug storage isolation chamber (204), forcing the gel material (2053) sealing the micro-hole puncture head (2051) to fall off or dissolve, and the drug liquid in the drug storage isolation chamber (204) is released outward through the drug release channel (2052) and the micro-hole puncture head (2051).

2. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The inner capsule (201) is more resilient than the outer capsule (202).

3. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The puncture needle (205) and the outer capsule (202) are integrally formed from the same material.

4. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The puncture needle (205) can puncture the dense fibrous layer on the surface of the vascular plaque and anchor to the vascular wall simultaneously when the balloon is inflated, so as to prevent the balloon from slipping during the procedure.

5. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The height of the puncture needle (205) is 200 μm to 800 μm; The outer diameter of the micro-perforated puncture head (2051) is 50 μm to 200 μm.

6. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The puncture needles (205) are evenly distributed in an array along the axial and circumferential directions on the outer surface of the outer capsule (202); The axial spacing between adjacent spikes is 1 mm to 5 mm; The circumferential spacing between adjacent spikes is 1 mm to 5 mm.

7. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The inner diameter of the drug release channel (2052) gradually decreases along the direction close to the micro-perforated puncture head (2051).

8. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The gel material (2053) is a water-soluble gel or a pressure-sensitive gel. When the pressure inside the drug storage isolation cavity (204) reaches the preset pressure threshold, the gel material (2053) ruptures or dissolves to open the microporous puncture head (2051).

9. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The drug storage isolation cavity (204) is continuously arranged around the circumference of the balloon body (2).

10. The array-spike membrane-perforating targeted drug-loaded sandwich balloon according to claim 1, characterized in that, The distal and proximal ends of the inner capsule (201) are respectively sealed to the distal and proximal ends of the outer capsule (202).

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