A drug balloon delivery device

Abstract

The utility model discloses a kind of drug balloon delivery devices, including balloon auxiliary delivery catheter and drug balloon catheter, balloon auxiliary delivery catheter includes the tubular structure of tube body, the middle part of tube body is equipped with the guide slot of the communication tube body interior, drug balloon catheter includes the far end tube body, push rod, joint arranged in sequence, the end of far end tube body away from push rod is set as tip, drug balloon is sleeved in the outer one end of far end tube body, the end of drug balloon catheter with drug balloon can be inserted into tube body, for guiding the guide wire of surgical instrument can be inserted into far end tube body from tip, then from the middle part of far end tube body, again pass through guide slot.The utility model reduces the drug loss of drug coating balloon when conveying in blood vessel passage to the greatest extent, and it is convenient to operate, simple structure, safe and reliable.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically a drug balloon delivery device. Background Technology

[0002] Minimally invasive surgery has become a primary treatment for coronary artery disease and peripheral vascular disease. However, with the increasing use of stents, in-stent restenosis (ISR) has become a serious problem, with a recurrence rate as high as 27% after simple balloon angioplasty. In recent years, drug-eluting balloons (DCBs) have been gradually promoted and applied in the fields of coronary artery and peripheral intervention as a new interventional treatment technology in Europe and the United States. Several DCB products are also currently in clinical use in China.

[0003] Drug-eluting balloons (DCBs) deliver anti-proliferative drugs to the vessel wall via a balloon and release them evenly, inhibiting the proliferation of endothelial cells, smooth muscle cells, and fibroblasts, thus reducing restenosis after balloon dilation. The mechanism of action of DCBs in preventing and treating restenosis is similar to that of drug-eluting stents (DES), both reducing restenosis by inhibiting intimal hyperplasia with the delivered drug. However, the two differ in their drug delivery methods and duration of action. The most significant difference is that DCBs do not implant metal wires or polymer coatings that remain permanently in the vessel wall, embodying the novel interventional concept of "intervention without implantation." As a new interventional treatment technology, drug-eluting balloons (DCBs) achieve the goal of leaving no permanent or intermittent implants in the blood vessel, avoiding a series of problems caused by stent placement.

[0004] Drug-coated balloons (DBBs) can alleviate the side effects of balloon angioplasty and stent placement. However, drug loss is inevitable during delivery, affecting the final treatment outcome. In actual surgery, before reaching the target stenotic lesion, the DBB is subjected to friction from the hemostatic valve, blood flow, vessel wall friction, and relative catheter sliding friction. Furthermore, the drug coating loosens and is lost with the bloodstream the moment the balloon opens. If the procedure is not performed correctly or the vascular anatomy is complex, most of the drug in the balloon is lost during the procedure. Public data shows that in extreme cases, the drug utilization rate of DBBs is less than 20%. Therefore, the current technology for drug-coated balloons has a relatively low drug utilization rate, severely impacting the therapeutic effect. To ensure sufficient drug delivery to the diseased vessel wall, the initial drug load of the balloon must be increased; however, studies have shown that high doses of paclitaxel or sirolimus pose certain risks to human health.

[0005] To address the issue of drug loss during delivery, the drug-coated balloon catheter in invention patent (authorization announcement number: CN109011112B) uses an external protective sleeve B inserted into the inlet to prevent friction between the drug balloon and the hemostatic valve. The protective sleeve A can be torn distally to reduce friction when the balloon is withdrawn from the protective sleeve A, thus preventing drug loss during withdrawal. Patent CN213789513U describes a drug balloon delivery system with a protective device, including a drug balloon catheter and a protective sleeve. The protective sleeve comprises a protective sleeve, a connecting rod, and a handle connected sequentially from distal to proximal. The maximum inner diameter of the protective sleeve is larger than the maximum outer diameter of the expanded drug-coated balloon, while the outlet diameter of the protective sleeve is smaller than the maximum outer diameter of the expanded drug-coated balloon. The protective sleeve maximizes the prevention of drug loss during passage through the hemostatic valve and blood vessel wall, and maximizes drug delivery to the diseased tissue for absorption. Patent CN111375119A discloses a drug-coated balloon catheter with a detachable sheath, including a delivery catheter and a drug-coated balloon fixed to the distal end of the delivery catheter. A protective sheath is movably sleeved on the outside of the drug-coated balloon and the delivery catheter. The detachable sheath is fixed to the proximal end of the protective sheath and the delivery catheter, which can reduce the drug loss rate during packaging and delivery, and can prevent the delivery catheter from bending.

[0006] The drug-coated balloon catheters or systems mentioned above can reduce drug loss rates to some extent, but they also have drawbacks such as complex structures and a sacrifice of some operational convenience. For example, drug-coated balloon catheters with removable sheaths effectively reduce friction or erosion during balloon advancement, but the connection between the protective sheath and the removable sheath is complex, increasing the number of steps required during surgery and potentially introducing additional operational risks or prolonging the procedure. Furthermore, their protective sheaths employ an over-the-wire (OTW) design, requiring additional instruments or procedures to prevent guidewire displacement during retraction after the drug has been released at the lesion site. Utility Model Content

[0007] To address the aforementioned problems in the existing technology, the purpose of this utility model is to provide a drug delivery balloon device that minimizes drug loss during delivery of the drug-coated balloon in the vascular pathway while also being easy to operate. Furthermore, due to its simple structure, it is convenient to operate during pre-assembly, delivery, and withdrawal without the need for additional instruments, and is safe and reliable.

[0008] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0009] A drug delivery balloon device includes a balloon-assisted delivery catheter and a drug balloon catheter. The balloon-assisted delivery catheter includes a tubular body with a guide groove in the middle that connects to the interior of the body. The drug balloon catheter includes a distal body, a push rod, and a connector arranged sequentially. The end of the distal body furthest from the push rod is designated as a tip. A drug balloon is fitted over the distal body. The end of the drug balloon catheter containing the drug balloon can extend into the body. A guide wire for guiding surgical instruments can extend from the tip into the distal body, exit from the middle of the distal body, and then pass through the guide groove.

[0010] As a further improvement to the above technical solution:

[0011] The distal tube body includes a main tube and a guide wire tube. The length of the guide wire tube is less than the length of the main tube. The guide wire tube and the main tube share a portion of the sidewall. One end of the guide wire tube is provided with a guide wire cavity exchange bevel for the guide wire to enter and exit, and the other end is connected to the tip. The guide wire cavity exchange bevel is located in the middle of the main tube. The guide wire is inserted into the guide wire tube from the tip and then led out from the guide wire cavity exchange bevel.

[0012] One end of the tube is connected to the push rod, and the other end is connected to the drug balloon.

[0013] The balloon-assisted delivery catheter also includes a catheter hub and a tip. One end of the catheter body is connected to and communicates with the tip, and the other end of the catheter body is connected to the catheter hub. The hardness of the tip is lower than that of the catheter body.

[0014] The hardness of the tube gradually increases from the distal end to the proximal end.

[0015] The tube body has a multi-layered tubular structure, and the push rod is made of metal.

[0016] The tube body consists of three layers that are nested together from the inside out. The inner layer, middle layer, and outer layer of the tube body are respectively a polymer inner membrane, a metal reinforcement layer, and a polymer outer layer.

[0017] The first strain relief sleeve is fitted over the tube body, and one end of the first strain relief sleeve and one end of the tube body are connected to the same end of the guide tube seat. The second strain relief sleeve is fitted over the push rod, and one end of the second strain relief sleeve and one end of the push rod are connected to the same end of the connector.

[0018] The tube body is provided with at least one indicator ring that can be detected by X-rays for marking the position of the tube body, and the distal tube body is provided with at least one indicator that can be detected by X-rays for marking the position of the drug balloon.

[0019] The delivery device also includes an inlet sheath, with a Y-valve and / or hemostatic component connected to the end of the catheter seat away from the tube body. The inlet sheath, used to guide and protect the drug balloon, is fitted inside the catheter seat and / or the Y-valve and / or the hemostatic component.

[0020] Explanation of relevant terms:

[0021] Quick Exchange (RX): The guidewire does not pass through the entire catheter; only a portion of the catheter is advanced along the guidewire, making catheter replacement easier.

[0022] Over-the-Way (OTW): The guidewire runs through the entire catheter body. The OTW structure has better pushing and stability, but it is not convenient for exchanging instruments.

[0023] The beneficial effects of this utility model are:

[0024] (1) The balloon-assisted delivery catheter, the inlet sheath, and the drug-coated balloon catheter work together to effectively assist the drug balloon in entering the vascular access of minimally invasive surgery. During this process, friction between the drug balloon and the sealing ring of the hemostatic valve, the inner lumen of the access catheter (sheath), and the flushing of the drug by the blood flow in the blood vessel are minimized, thereby achieving efficient treatment of stenotic lesions and greatly reducing drug loss during the delivery of the drug-coated balloon.

[0025] (2) The structure is simple and compact, allowing for pre-assembly outside the body. It offers excellent operational convenience and quality stability, making it user-friendly for surgeons. The drug delivery sheath of the safe and efficient auxiliary drug delivery balloon catheter, along with other components, is delivered via a Y-valve or hemostatic valve. Compared to existing drug delivery technologies, it significantly improves the safety and convenience of procedures such as ISR, ensuring non-invasiveness to surrounding blood vessels during use.

[0026] (3) The combined use of a balloon-assisted delivery catheter and a drug-coated balloon catheter provides stronger support for the device, facilitating the smooth delivery and placement of interventional instruments. The distal end of the balloon-assisted delivery catheter is designed with a guide groove, the number and shape of which are not specifically limited. This guide groove allows the guide wire to pass through the balloon-assisted delivery catheter, achieving spatial separation between the guide wire and the proximal push rod of the drug-coated balloon catheter, avoiding entanglement. This improves the problem of guide wire and push rod entanglement during the operation. During withdrawal, there is no need to use guide wire extension technology, pressure pump backflush technology, or other catheter replacement technology, and no additional auxiliary instruments are required. The operation is simple and convenient, with significant benefits for both the operator and the patient. It solves the problems of multiple guide wires and push rod entanglement of RX catheters and the shortcomings of guide wire displacement during withdrawal of OTW catheters, reducing instrument exchanges, lowering complications, and being patient-friendly.

[0027] (4) The processing and manufacturing are simple. The processing technology of the balloon-assisted delivery catheter, the inlet sheath and the drug balloon catheter are all commonly used processes in the production of medical consumables. They are safe and reliable. At the same time, the manufacturing process of the balloon-assisted delivery catheter, the inlet sheath and the drug balloon catheter is simple and controllable, and the product quality is stable. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the balloon-assisted delivery catheter structure of this utility model.

[0029] Figure 2 yes Figure 1 A partial structural diagram.

[0030] Figure 3 yes Figure 1 A schematic diagram of one embodiment of the AA cross-section.

[0031] Figure 4 yes Figure 1 A schematic diagram of another embodiment of the AA cross section.

[0032] Figure 5 yes Figure 1 A schematic diagram of another embodiment of the AA cross section.

[0033] Figure 6 This is a schematic diagram of the structure of the drug balloon catheter of this utility model.

[0034] Figure 7 yes Figure 6 A schematic diagram of the distal tube structure.

[0035] Figure 8 This is a schematic diagram of the pre-assembled structure of the balloon-assisted delivery catheter and the drug balloon catheter of this utility model.

[0036] Figure 9 This is a schematic diagram of the delivery device of this utility model releasing the drug.

[0037] Figure 10 This is a schematic diagram of the inlet sheath of this utility model. Detailed Implementation

[0038] The specific embodiments of this utility model will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit the scope of this utility model.

[0039] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.

[0040] A drug delivery balloon device, such as Figures 1-10 As shown, it includes a balloon-assisted delivery catheter 1, an induction sheath, and a drug balloon catheter 3.

[0041] Balloon-assisted delivery catheter 1 Figures 1-5 As shown, the device includes a tube body 101, a first strain relief sleeve 102, and a conduit seat 103. Both the tube body 101 and the first strain relief sleeve 102 are tubular structures. The length of the first strain relief sleeve 102 is less than the length of the tube body 101, and the inner diameter of the first strain relief sleeve 102 is not less than the outer diameter of the tube body 101. The first strain relief sleeve 102 is sleeved on the outside of the tube body 101, and one end of the first strain relief sleeve 102 and one end of the tube body 101 are connected to the same end of the conduit seat 103.

[0042] The tube body 101 has a multi-layered tubular structure. Preferably, the tube body 101 comprises three layers nested sequentially from the inside out. The inner, middle, and outer layers are respectively a polymer inner membrane, a metal reinforcing layer 107, and a polymer outer layer, which are composites. Alternatively, they can be directly extruded from polymer materials. The first strain release sleeve 102 is made of a highly flexible polymer material to prevent damage to the proximal end of the tube body 101 during operation. The proximal end refers to the end of the corresponding component closer to the operator, while the distal end refers to the end of the corresponding component farther from the operator. Preferably, the first strain release sleeve 102 is made of polyolefin (PO) or thermoplastic polyurethane elastomer (TPU) through thermorheological processing, resulting in high connection strength with the tube body 101, suitable flexibility, easy operator control, and resistance to breakage of the tube body 101. The catheter hub 103 is made of medical-grade plastic through injection molding or a hub assembly connection for operator control. Preferably, the catheter hub 103 is injection molded from polycarbonate or polyamide to connect to other external instruments such as Y valves and hemostatic valve connectors.

[0043] In this embodiment, the inner layer of the tube body 101 is polytetrafluoroethylene (PTFE), the middle braided metal reinforcing layer 107 is made of heat-treated stainless steel or nickel-titanium wire, and the outer layer is polyurethane (PU), block polyamide (PEBAX), or polyamide (PA). The outer layer material of the tube body 101 is formed by polymer rheology, and the hardness of the tube body 101 gradually increases from the distal end to the proximal end. In other words, the hardness of at least one layer of the tube body 101 gradually increases from the distal end to the proximal end. This achieves excellent flexibility, radial support, and pushing ability of the tube body 101.

[0044] The three layers of material in the tube body 101 are fused together by heating or rheological means, giving the tube body high quality of inner and outer surfaces and dimensional accuracy, ensuring good fit and passage between devices, and at the same time, not causing damage to blood vessels.

[0045] The distal end of the tube body 101 is designed with a head end 104 and a guide groove 105. The guide groove 105 is an opening formed on the side wall of the tube body 101 that connects to the inner cavity of the tube body 101. The main function of the guide groove 105 is to guide the guide wire 4 through the inner cavity of the tube body 101. Preferably, one or more guide grooves 105 can be provided, such as... Figure 3 and 5 It is a structure with a guide groove 105 set on the same cross section. Figure 4 The structure consists of two guide grooves 105 on the same cross section. The shape and size of the guide grooves 105 are not specifically limited. Preferably, the guide grooves 105 are rectangular or trapezoidal, with a width slightly larger than the outer diameter of the guide wire 4 to be passed through. The multilayer material corresponding to the slotted position of the guide groove 105 can be the same as the main body of the tube 101, or it can adopt other different designs, such as a single-layer polymer material. Preferably, the polymer material in this part is transparent to facilitate observation of the movement position of the end of the guide wire 4. Preferably, there is no metal reinforcing layer 107 at the slotted part of the guide groove 105, which helps to improve the dimensional accuracy of the guide groove 105 and maintain the consistency of the slotted part of the guide groove 105 with the inner and outer diameter dimensions of the tube 101 as much as possible. The guide grooves 105 are processed by laser drilling or mechanical drilling, achieving high processing accuracy and ensuring that the guide wire 4 can pass through smoothly. The metal reinforcing layer 107 can be arranged in a circle around the circumference of the tube 101 (avoiding only the guide grooves 105), such as... Figure 3 and 4 As shown, it is also possible to set only a portion around the circumference of the tube body 101, instead of the entire circumference, as shown in the example. Figure 5 As shown.

[0046] The tip 104 is a hollow structure, connected to the distal end of the tube body 101. A guide groove 105 is located between the tip 104 and the first strain release sleeve 102. The tip 104 is made of a low-hardness single-layer polymer material and is joined to the tube body 101 using a pointed molding die. The tip 104 is rounded and flexible to avoid damaging blood vessels and to prevent drug abrasion and detachment during relative movement with the drug-eluting balloon 301. Preferably, the tip 104 is less than 10 mm in length and is made of a soft, transparent single-layer polymer material.

[0047] One or more marker rings 106 are also provided at the distal end of the catheter body 101. The marker rings 106 can be visualized on the terminal display device, making it easy for the operator to determine their position. Preferably, marker rings 106 are provided at the distal ends of the tip 104 and the guide groove 105, which facilitates real-time positioning of the distal end of the balloon-assisted delivery catheter 1 and the distal end of the guide groove 105 during the operation. It also facilitates observation of the separation of the drug balloon 301 (see description below) from the balloon-assisted delivery catheter 1, as well as the relative position of the drug balloon 301 and the guide groove 105. The marker rings 106 are markers that can be detected by X-rays. The marker rings 106 can be made of Ta rings or platinum-iridium rings. The marker rings 106 are set at the target position by laser welding or polymer material coating. The position of the marker rings 106 can determine the relative position of the tip 104 of the balloon-assisted delivery catheter 1 to the target lesion or the position of the guide groove 105 in the blood vessel.

[0048] Drug-eluting balloon catheter 3 Figure 6 and 7 As shown, it includes a tip 300, a drug balloon 301, a distal tube 302, a push rod 303, a second strain release sleeve 305, and a connector 306 arranged sequentially from distal to proximal.

[0049] The tip 300 is a tubular structure, or has a through-hole, allowing the guidewire 4 to pass through. The tip 300 provides an entry point for the guidewire 4; its rounded and flexible shape avoids damage to blood vessels, facilitates guiding the product to the lesion site, and provides a smooth transition from the guidewire 4 to the drug-eluting balloon 301. The tip 300 is made of a low-hardness polymer material.

[0050] The drug-eluting balloon 301 has a drug-eluting coating on its outer surface. Under recommended pressure, the drug-eluting balloon 301 can expand to a known diameter and length using an inflation medium. Under negative pressure, the drug-eluting balloon 301 can return to its contracted state. The drug-eluting balloon 301, inflated and stretched using a plastic tube, is the main component of the drug-eluting balloon catheter 3, used to dilate the lesion site and deliver the drug to the vessel wall for release.

[0051] The drug-eluting balloon 301 can be positioned in real time by one or two markers 307 located below it. The markers 307 can be made of Tungsten or a platinum-iridium alloy. The position of the drug-eluting balloon 301 can be determined by X-ray imaging of the markers 307. The markers 307 can be installed on the guidewire tube 3022 (see below) by laser welding, mechanical embedding, or coating with polymer materials.

[0052] Remote tube body 302 Figure 6 and 7 As shown, one end of the distal tube 302 is connected to the tip 300, and the other end is connected to the push rod 303. Alternatively, one end of the distal tube 302 can be directly set as the tip 300. The distal tube 302 includes a main tube 3021 and a guidewire tube 3022. The guidewire tube 3022 provides a channel for the guidewire 4, which is equivalent to the inner lumen of the guidewire tube 3022 being the guidewire lumen 3024. The main tube 3021 provides a channel for the inflation or deflation of the drug-eluting balloon 301, and its inner lumen is the inflation lumen 3025. Specifically, the guidewire tube 3022 is shorter than the main tube 3021. The guidewire tube 3022 and the main tube 3021 share a portion of their sidewalls. One end of the guidewire tube 3022 has a guidewire lumen exchange bevel 304 for the guidewire 4 to enter and exit, and the other end is connected to the tip 300. The guidewire lumen exchange bevel 304 is located in the middle of the main tube 3021. The guidewire 4 passes through the tip 300 and the guidewire lumen 3024 and is then led out from the guidewire lumen exchange bevel 304. One end of the main tube 3021 is connected to the push rod 303, and the other end is connected to the drug-eluting balloon 301. The drug-eluting balloon 301 is fitted over the distal tube body 302. Specifically, the drug-eluting balloon 301 is fitted over both the main tube 3021 and one end of the guidewire tube 3022, and is located between the guidewire lumen exchange bevel 304 and the tip 300. To make the overall diameter of the distal tube 302 more uniform, the main tube 3021 is designed as two sections with different inner diameters. The section with the smaller inner diameter is connected to the guide wire tube 3022 with the same sidewall, so that the outer diameter of the overall structure formed by the connection of one section of the main tube 3021 and the guide wire tube 3022 is basically equal to the outer diameter of the other section of the main tube 3021.

[0053] In other words, the distal tube 302 is also equivalent to setting a partition (i.e., the sidewall shared by the main tube 3021 and the guidewire tube 3022) inside a tubular structure. The partition separates the internal cavity of the tubular structure into two independent spaces, namely the guidewire cavity 3024 and the filling cavity 3025. Two through holes are opened on the outer wall of the tubular structure, one is the guidewire cavity exchange oblique opening 304 connecting the guidewire cavity 3024, and the other is the opening connecting the drug balloon 301.

[0054] Furthermore, both the guide wire 3022 and the main tube 3021 of the distal tube body 302 are extruded single-lumen tubes. Preferably, the guide wire 3022 is a three-layer tube, and the main tube 3021 is a single-layer tube. The inner layer of the guide wire 3022 is made of high-density polyethylene (HDPE), a material with a low coefficient of friction, which can reduce the friction of the guide wire 4 passing through; the middle layer of the guide wire 3022 is used to connect the inner layer and the outer layer of the guide wire 3022, and is preferably made of low-density polyethylene (LDPE); the outer layer of the guide wire 3022 and the main tube 3021 provide pushing force for the distal tube body 302, and is preferably made of polyamide (PA). The design of the distal soft end and proximal hard end of the distal tube body 302 achieves a good combination of tracking and pushing performance.

[0055] In this embodiment, the connection between the distal tube 302 and the drug balloon 301, and the connection between the distal tube 302 and the push rod 303, are achieved by laser welding, bonding, or hot-melt processing.

[0056] The push rod 303 is a hollow tube. The distal end of the push rod 303 is connected to the distal tube body 302, and the proximal end is connected to the connector 306. The connector 306 has a connection port, which is connected to an external inflation or liquid filling device. The fluid in the external inflation or liquid filling device sequentially passes through the inner cavity of the push rod 303 and the filling cavity 3025 to inflate / depressurize the drug-eluting balloon 301.

[0057] The connector 306 is made of medical-grade plastic, and the second strain relief sleeve 305 is preferably made of polyolefin (PO), thermoplastic polyurethane elastomer (TPU), or block polyamide (Pebax). The connector 306 and the second strain relief sleeve 305 can be integrally molded by injection molding, or the second strain relief sleeve 305 can be assembled onto the push rod 303.

[0058] The inner diameter of the tube body 101 is larger than the maximum outer diameter of the drug balloon 301 when it is in the contracted state. This facilitates pushing or pulling the drug balloon 301 in the balloon-assisted delivery catheter 1 and can reduce drug loss during the pushing or pulling process of the drug balloon 301 in the balloon-assisted delivery catheter 1.

[0059] The push rod 303 is preferably made of metal, such as a hyaluronic acid tube.

[0060] The inlet sheath is used to guide the drug delivery balloon 301 smoothly through the catheter hub 103 and the Y valve 5 and / or hemostatic components connected to the catheter hub 103. The inlet sheath, for example... Figure 10As shown, the inlet sheath is an extruded single-lumen tube. The proximal end of the inlet sheath has a guide bevel 201, i.e., an inclined inlet / outlet, and the tube body has a side slit 202. The outer diameter of the inlet sheath must be smaller than the inner diameter of the hemostatic valve sealing ring, and the inner diameter of the inlet sheath must be larger than the maximum outer diameter of the drug-eluting balloon catheter 3 to be inserted in the contracted state. The guide bevel 201 and side slit 202 are manufactured using physical cutting methods, resulting in smooth and rounded cut edges that do not damage the accompanying instruments.

[0061] The induction sheath is made of materials such as polytetrafluoroethylene (PTFE) or ethylene-tetrafluoroethylene copolymer (ETFE).

[0062] Based on the above structure, the working principle and process of this invention are as follows:

[0063] Pre-assembly of the balloon-assisted delivery catheter 1 and the drug delivery balloon catheter 3 is completed in vitro: the proximal catheter seat 103 of the balloon-assisted delivery catheter 1 is connected to other hemostatic components such as the Y valve 5 or a hemostatic valve connector. First, the inlet sheath is passed through the sealing ring of the Y valve 5, which is equivalent to the inlet sheath being fitted inside the sealing ring. The inner diameter of the inlet sheath is larger than the maximum outer diameter of the drug delivery balloon 301 in the contracted state. At this time, when the drug delivery balloon 301 at the distal end of the drug delivery balloon catheter 3 is guided through the inlet sheath through the Y valve 5, the drug delivery balloon 301 will be protected from being scraped by the sealing ring of the Y valve 5 or the tube wall, thus minimizing drug loss.

[0064] Continue advancing the drug delivery balloon catheter 3 until the effective length of the guidewire lumen of its distal tube 302 is fully inserted into the balloon-assisted delivery catheter 101. At this point, separate the push rod 303 at the proximal end of the drug delivery balloon catheter 3 from the lumen of the inlet sheath along the side seam 202 of the inlet sheath and remove the inlet sheath. Finally, further advance the proximal end of the drug delivery balloon catheter 3 until the drug balloon 301 is completely within the tip 104 of the balloon-assisted delivery catheter 1, always keeping the tip 300 within the range of the tip 104 of the balloon-assisted delivery catheter. Figure 8 As shown, at this time, the guidewire lumen exchange bevel 304 faces the guide groove 105 to facilitate the removal of the guidewire 4. During in vitro pre-assembly, since the inner diameter of the tube body 101 of the balloon-assisted delivery catheter 1 is larger than the maximum outer diameter of the drug balloon 301 in the contracted state, and the tube body 101 is kept as straight as possible, during the process of pushing the drug balloon 301 from the proximal end to the distal end of the balloon-assisted delivery catheter 1, the drug coated on the drug balloon 301 is not washed away by blood and has less friction with the inner wall of the balloon-assisted delivery catheter 1, ultimately achieving low drug loss.

[0065] Guided by the guidewire 4, a guiding catheter or catheter sheath (not shown in this document) establishes a pathway to the target lesion vessel. The distal end of the assembled delivery device, 302, and the guidewire lumen 3024 are passed through the guidewire 4, i.e., the guidewire 4 is inserted into the tip 300, while simultaneously pushing the balloon-assisted delivery catheter 1 and the drug-eluting balloon catheter 3 until the proximal end of the guidewire 4 emerges from the guide slot 105. An external force is applied (achieved by the surgeon changing the position of the delivery device or guidewire to alter their relative positions) to guide the guidewire 4 out of the guide slot 105. The guidewire 4 is then fixed, and the delivery device consisting of the balloon-assisted delivery catheter 1 and the drug-eluting balloon catheter 3 continues to be pushed through the guiding catheter to reach the target lesion vessel.

[0066] Fix the guide wire 4 and the drug delivery balloon catheter 3, then withdraw the balloon-assisted delivery catheter 1 a certain distance until the drug delivery balloon 301 is fully exposed in the blood vessel. Inflate the drug delivery balloon 301 using an external pneumatic or liquid-filled device and ensure it is sufficiently close to the stenotic lesion B. Figure 9 As shown, after maintaining the drug for a period of time until it is fully released, the drug balloon 301 is retracted into the balloon-assisted delivery catheter body 101, the guide wire 4 is fixed, and the balloon-assisted delivery catheter 1 and the drug balloon catheter 3 are withdrawn and completely removed from the body.

[0067] It should be noted that the drug-eluting balloon 301, once inflated, seals the cavity in which it is located. The drug-eluting balloon 301 can adopt a variety of different structures and shapes.

[0068] Finally, it is necessary to state that the above embodiments are only used to further illustrate the technical solution of this utility model in detail, and should not be construed as limiting the scope of protection of this utility model. Any non-essential improvements and adjustments made by those skilled in the art based on the above content of this utility model shall fall within the scope of protection of this utility model.

Claims

1. A drug balloon delivery device, characterized by, The device includes a balloon-assisted delivery catheter (1) and a drug balloon catheter (3). The balloon-assisted delivery catheter (1) includes a tubular body (101) with a guide groove (105) in the middle of the body (101) that connects to the inside of the body (101). The drug balloon catheter (3) includes a distal body (302), a push rod (303), and a connector (306) arranged in sequence. The end of the distal body (302) away from the push rod (303) is designated as a tip (300). The drug balloon (301) is sleeved on the outside of the distal body (302). The end of the drug balloon catheter (3) with the drug balloon (301) can extend into the body (101). The guide wire (4) used to guide surgical instruments can extend from the tip (300) into the distal body (302) and then be led out from the middle of the distal body (302) and pass through the guide groove (105).

2. The drug balloon delivery device of claim 1, wherein: The distal tube body (302) includes a main tube (3021) and a guide wire tube (3022). The length of the guide wire tube (3022) is less than the length of the main tube (3021). The guide wire tube (3022) and the main tube (3021) share a portion of the sidewall. One end of the guide wire tube (3022) is provided with a guide wire cavity exchange bevel (304) for the guide wire (4) to enter and exit, and the other end is connected to the tip (300). The guide wire cavity exchange bevel (304) is located in the middle of the main tube (3021). The guide wire (4) extends into the guide wire tube (3022) from the tip (300) and then exits from the guide wire cavity exchange bevel (304).

3. The drug balloon delivery device of claim 2, wherein: One end of the main unit (3021) is connected to the push rod (303), and the other end is connected to the drug balloon (301).

4. The drug balloon delivery device of claim 1, wherein: The balloon-assisted delivery catheter (1) also includes a catheter seat (103) and a tip (104). One end of the tube body (101) is connected to and communicates with the tip (104), and the other end of the tube body (101) is connected to the catheter seat (103). The hardness of the tip (104) is lower than that of the tube body (101).

5. The drug balloon delivery device of claim 1, wherein: The hardness of the tube body (101) gradually increases from the distal end to the proximal end.

6. The drug balloon delivery device of claim 5, wherein: The tube body (101) is a multi-layered tubular structure, and the push rod (303) is made of metal.

7. The drug balloon delivery device of claim 6, wherein: The tube body (101) consists of three layers that are sequentially connected from the inside to the outside. The inner layer, middle layer and outer layer of the tube body (101) are a polymer inner membrane, a metal reinforcing layer (107) and a polymer outer layer, respectively.

8. The drug balloon delivery device of claim 1, wherein: The first strain relief sleeve (102) is sleeved outside the tube body (101). One end of the first strain relief sleeve (102) and one end of the tube body (101) are connected to the same end of the guide tube seat (103). The second strain relief sleeve (305) is sleeved outside the push rod (303). One end of the second strain relief sleeve (305) and one end of the push rod (303) are connected to the same end of the connector (306).

9. The drug balloon delivery device of claim 1, wherein: The tube body (101) is provided with at least one X-ray detectable marker ring (106) for marking the position of the tube body (101), and the distal tube body (302) is provided with at least one X-ray detectable marker (307) for marking the position of the drug balloon (301).

10. The drug balloon delivery device of claim 1, wherein: The delivery device also includes an inlet sheath, with a Y valve (5) and / or a hemostatic component connected to one end of the catheter seat (103) away from the tube body (101). The inlet sheath for guiding and protecting the drug balloon (301) is fitted inside the catheter seat (103) and / or the Y valve (5) and / or the hemostatic component.

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