Intracranial hypotension drug-coated balloon dilatation catheter

Abstract

The present invention discloses an intracranial low-pressure drug-coated balloon dilatation catheter, which belongs to the field of medical device technology and comprises: a balloon dilatation catheter assembly, comprising an outer tube and a guide end tube connected to one end of the outer tube; a balloon component, fixed on the peripheral outer wall of the outer tube near one end of the guide end tube, the peripheral outer wall of the balloon component having a drug component; a drug-coated wrapping protection component, comprising an elastic wrapping expansion body fully enclosed and wrapped around the circumference of the balloon component; wherein, when the balloon component is inflated and expanded, the elastic wrapping expansion body is squeezed, so that the elastic wrapping expansion body is opened after synchronous elastic expansion to expose the drug component, and the drug component is applied to the blood vessel wall of the affected area, and the elastic wrapping expansion body comprises two symmetrically arranged halves of the elastic expansion body. The present invention protects the drug components on the surface of the balloon component, preventing them from being washed away by blood or released prematurely before reaching the target position, and effectively protecting the integrity and activity of the drug components during the delivery process.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, in particular to an intracranial hypotensive drug-coated balloon dilatation catheter. Background Art

[0002] Intracranial vascular stenosis or occlusion is one of the leading causes of serious neurological diseases, including stroke. Traditional treatments include medication, surgery, and interventional therapy, with balloon dilation being a commonly used interventional procedure. By inserting a balloon catheter into the lesion and inflating it, the narrowed vessel can be effectively dilated and blood flow restored. However, existing balloon dilation catheters have several practical issues and limitations that limit their therapeutic efficacy and patient safety.

[0003] Traditional balloon dilatation catheters usually do not have a drug protection structure, making it difficult to ensure that the drug is evenly distributed in the lesion site, resulting in the drug being washed away by the blood during delivery. Premature release or loss of the drug may cause the local drug concentration to be too high or too low, affecting the treatment effect. Summary of the Invention

[0004] The purpose of the present invention is to provide an intracranial hypotensive drug-coated balloon dilatation catheter to solve the problems raised in the background technology.

[0005] To achieve the above-mentioned object, the present invention provides the following technical solution: an intracranial hypotensive drug-coated balloon dilatation catheter, comprising:

[0006] The balloon dilatation catheter assembly includes an outer tube and a guide end tube connected to one end of the outer tube;

[0007] The balloon component is fixed on the peripheral outer wall of the outer tube near one end of the guide end tube, and the peripheral outer wall of the balloon component has a medicine component;

[0008] The drug coating and protection component includes an elastically wrapped expansion body that is fully enclosed and wrapped around the circumference of the balloon component;

[0009] When the balloon is inflated, it squeezes the elastically wrapped expansion body, so that the elastically wrapped expansion body is elastically expanded synchronously and then opens to expose the drug component, and the drug component is applied to the blood vessel wall of the affected area.

[0010] Preferably, the elastically wrapped expansion body comprises two symmetrically arranged halves of the elastic expansion body, and the opposite ends of the two halves of the elastic expansion body are sealed and connected together by a first tearable point line;

[0011] Furthermore, the two halves of the elastic expansion bodies are arranged to be rolled back and away from each other on the circumference of the balloon component.

[0012] Preferably, in this solution, the balloon component includes a first side expansion portion and a second side expansion portion, and opposite ends of the two halves of the elastic expansion body are fixedly wrapped around the outer walls of the first side expansion portion and the second side expansion portion respectively.

[0013] In this solution, preferably, a plurality of medicine grooves are provided in an annular array on the outer wall of the balloon member between the first side end expansion portion and the second side end expansion portion;

[0014] A portion of the medicine pieces are stored and accumulated in the medicine trough;

[0015] Another part of the drug component is coated on the first side end expansion portion, the second side end expansion portion and between two adjacent drug groove portions and is located on the outer wall of the balloon component.

[0016] In this embodiment, each of the medicine troughs preferably has a rounded sloped portion disposed between its two side edges and the outer wall of the balloon. If sharp corners were formed between the two side edges of the medicine trough and the outer wall of the balloon, the two side edges of the medicine trough would be squeezed and deformed toward the inside of the medicine trough when the balloon is inflated. The rounded sloped portion, in lieu of sharp corners, prevents the medicine from becoming stuck in the gap between the inner wall of the medicine trough and the two side edges, thereby reducing drug blockage losses.

[0017] In this embodiment, each of the drug troughs preferably has an expansion and rebound portion located on the inner wall of the balloon member behind the drug trough, and the expansion and rebound portion is integrally formed with the balloon member. When the balloon member is inflated, the gas naturally lifts the expansion and rebound portion, thereby discharging the drug in the drug trough into the blood vessel wall, thereby preventing the drug from accumulating at the bottom of the drug trough and being unable to be discharged.

[0018] In this solution, at least two ball caps are bonded to the outer walls of the two half-elastic expansion bodies at one end, and the outer wall of each ball cap is connected to an elastic pull wire, which is tightened on the outer wall of the half-elastic expansion body. The opposite ends of the elastic pull wires on the two half-elastic expansion bodies are fixedly connected to the first side expansion part and the second side expansion part respectively. When the elastically wrapped expansion body is synchronously expanded and propped up, the first tearable point line is disconnected, so that the two half-elastic expansion bodies retreat behind each other under the action of their own elasticity, and at the same time, the elastic pull wire elastically pulls the ball cap, and the ball cap is connected to the free end of the half-elastic expansion body, so that after the half-elastic expansion body is disconnected, the elastic pull wire quickly pulls the ball cap, so that the two half-elastic expansion bodies are rolled up in opposite directions. The elastic pull wire can further improve the disconnection and retreat efficiency of the half-elastic expansion body.

[0019] Preferably, in this solution, both ends of the balloon member are provided with side medicine pouches located on the circumference of the outer tube, and the inner ring walls of the two side medicine pouches are integrally connected with a separator ring body, and the perforation of the separator ring body is sleeved on the outer tube;

[0020] The separating ring body symmetrically divides the inner circle of the side end medicine bag into an expansion snap-fit ​​cavity and a limit rebound cavity. Each of the expansion snap-fit ​​cavities and the inner wall of the side end medicine bag has a second tearable point line, and the interior of the side end medicine bag has a medicine storage cavity for containing medicines.

[0021] Preferably, the expansion clamping cavities of the two side end medicine pouches are frictionally clamped on the outer walls of the adjacent first side end expansion part and the second side end expansion part respectively. When the balloon is inflated, the first side expansion part and the second side expansion part are also inflated. At this time, the first side expansion part and the second side expansion part will squeeze the expansion clamping cavity of the two side medicine bag bags, and the inner walls of the two expansion clamping cavities are squeezed and deformed, so that the second tearable point line is broken. At this time, the two side medicine bag bags have not yet slipped off the first side expansion part and the second side expansion part, so the medicine will not spill out. Under the squeezing force, the two expansion clamping cavities are gradually squeezed and rubbed against the outer walls of the first side expansion part and the second side expansion part. When the two half elastic expansion bodies are stretched open, the two side medicine bag bags are completely knocked off the first side expansion part and the second side expansion part by the elastic backward reaction force of the half elastic expansion body itself and the elastic pull line, and slide down to the side of the outer tube. As the side medicine bag bags slide, the medicine in the medicine storage cavity is spilled onto the blood vessel wall, which plays a further therapeutic role after the medicine on the outer wall of the balloon is applied.

[0022] In a preferred embodiment of the present invention, the two side-end drug pouches are located on opposite sides of the outer tube and are fixed with limiting rings, and the outer walls of each of the separating ring bodies are fixed with multiple extrusion springs on both sides. The extrusion springs away from the limiting rings elastically abut against the outer walls of the first and second side-end expansion parts, respectively, while the extrusion springs close to the limiting rings elastically abut against the inner walls of the limiting rings. When the side-end drug pouches are struck by the half elastic expansion body, the elastic pull line, and the ball cap, the side-end drug pouches slide around the outer tube. At the same time, under the setting of the extrusion springs on both sides, the sliding of the side-end drug pouches drives the limiting rings to collide with the first and second side-end expansion parts, and the limiting rings, thereby causing the two side-end drug pouches to elastically swing back and forth between the limiting rings and the first and second side-end expansion parts, respectively, thereby further accelerating the shaking out of the drug from the drug storage cavity, accelerating the discharge of the drug, and improving the efficiency of drug application to the blood vessel wall.

[0023] Compared with the prior art, the technical effects and advantages of the present invention are:

[0024] The elastically wrapped expansion body of this intracranial low-pressure drug-coated balloon dilatation catheter, when not in use, tightly wraps around the balloon, forming a closed structure. This structure protects the drug on the balloon surface, preventing it from being washed away by blood or prematurely released before reaching the target location, effectively maintaining the integrity and activity of the drug during delivery.

[0025] The drug coating and protection assembly includes an elastic expansion body that fully encloses the balloon, protecting the drug from the external environment. When the balloon is inflated, the elastic expansion body simultaneously expands and opens, exposing the drug and depositing it on the vessel wall. This ensures that the drug is released at the correct time and location, concentrating it in the area of ​​treatment and improving its local concentration. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0027] Figure 1 It is a structural schematic diagram of the present invention;

[0028] Figure 2 This is a schematic diagram of the structure of the first easy-tear point line in a disconnected state of the present invention;

[0029] Figure 3 This is a schematic diagram of the connection structure of the elastic pull wire of the present invention;

[0030] Figure 4 It is a structural schematic diagram of the medicine groove portion of the present invention;

[0031] Figure 5 For the present invention Figure 4 Schematic diagram of the enlarged structure at A in the middle;

[0032] Figure 6 is a cross-sectional view of the balloon member of the present invention;

[0033] Figure 7 This is a schematic diagram of the structure of the drug component of the present invention coated on the balloon component;

[0034] Figure 8 This is a schematic diagram of the connection structure of the second easy-to-tear point line of the present invention;

[0035] Figure 9 This is a schematic structural diagram of the extrusion spring of the present invention in a disassembled state;

[0036] Figure 10 It is a cross-sectional view of the side medicine pouch of the present invention.

[0037] Description of reference numerals:

[0038] In the figure: 1. Balloon dilatation catheter assembly; 2. Outer tube; 3. Guide end tube; 4. Drug coating protection component; 5. Elastic wrapped expansion body; 6. First tear-off point line; 7. Side end drug bag; 8. Balloon component; 9. Half elastic expansion body; 10. Limiting ring; 11. Elastic pull line; 12. Ball head cap; 13. Drug component; 14. First side end expansion part; 15. Second side end expansion part; 16. Drug groove part; 17. Chamfered slope part; 18. Expansion rebound part; 19. Separation ring body; 20. Perforation; 21. Second tear-off point line; 22. Extrusion spring; 23. Expansion clamping cavity; 24. Limiting rebound cavity; 25. Drug storage cavity. DETAILED DESCRIPTION

[0039] In the following description, numerous specific details are provided to provide a more thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without one or more of these details. In other instances, certain technical features well known in the art are not described to avoid confusion with the present invention.

[0040] Unless otherwise defined, the directions of up, down, left, right, front, back, inside and outside involved in this document are based on the directions of up, down, left, right, front, back, inside and outside shown in the figures of the present invention, and are explained here together.

[0041] This embodiment provides Figures 1 to 10 The intracranial low-pressure drug-coated balloon dilatation catheter shown includes: a balloon dilatation catheter assembly 1, a balloon component 8, and a drug-coated protective component 4.

[0042] In this embodiment, the balloon dilatation catheter assembly 1 comprises an outer tube 2 and a guide end tube 3 connected to one end of the outer tube 2. The outer tube 2 serves as a guide path, supporting and protecting the internal balloon assembly 8 and the side drug sachet 7. The guide end tube 3 assists in positioning the catheter at the target location, and its flexible design helps the catheter navigate complex and tortuous vascular pathways. This improves positioning accuracy and reduces surgical risks, ensuring smooth intravascular movement and minimizing damage to surrounding tissue.

[0043] In this embodiment, a balloon member 8 is fixed to the outer wall of the outer tube 2 near the guide tube 3. The outer wall of the balloon member 8 is provided with a drug member 13. The balloon member 8 primarily performs the task of vasodilation. By inflating, it expands the narrowed or occluded blood vessel segment and restores normal blood flow.

[0044] In this embodiment, the drug coating protection assembly 4 comprises an elastically encapsulated expansion body 5 that completely encloses the balloon element 8. This assembly protects the drug coating from environmental influences until the moment of use. The elastically encapsulated expansion body 5 remains sealed in the deployed state, ensuring the effectiveness of the drug element 13 until it is released to the intended area. The elastically encapsulated expansion body 5 expands as the balloon element 8 expands, exposing the drug element 13. When the balloon is inflated, the elastically encapsulated expansion body 5 expands simultaneously, allowing the drug to directly contact the lesion, achieving localized drug delivery and improving treatment efficiency.

[0045] In this embodiment, when the balloon 8 is inflated, it squeezes the elastically wrapped expansion body 5, causing the elastically wrapped expansion body 5 to expand synchronously and then open to expose the drug 13, and the drug 13 is applied to the blood vessel wall of the affected area.

[0046] In this embodiment, the elastically wrapped expansion body 5 includes two symmetrically arranged halves of the elastic expansion body 9, and the two halves of the elastic expansion body 9 are sealed together at opposite ends by a first tear-off point line 6; the first tear-off point line 6 connects the two halves of the elastic expansion body 9 and breaks under inflation pressure. Controlling the separation process of the elastically wrapped expansion body 5 ensures that the drug is evenly distributed and released. The half elastic expansion body 9 and the elastically wrapped expansion body 5 together form a complete wrapping structure. After the balloon part 8 is expanded, they will separate to expose the drug part 13, allowing the drug to directly contact the blood vessel wall. In addition, the two halves of the elastic expansion body 9 are arranged to be rolled back in opposite directions on the sides of the balloon part 8.

[0047] In this embodiment, the balloon member 8 includes a first side expansion portion 14 and a second side expansion portion 15. The two opposite ends of the elastic expansion body 9 are fixedly wrapped around the outer walls of the first and second side expansion portions 14, 15, respectively. The first and second side expansion portions 14, 15 are part of the balloon member 8 and are responsible for expanding specific areas.

[0048] In this embodiment, a plurality of drug grooves 16 are provided in a circular array between the first side end expansion portion 14 and the second side end expansion portion 15 and on the circumferential outer wall of the balloon component 8; a portion of the drug components 13 are stored and accumulated in the drug grooves 16; another portion of the drug components 13 are coated on the first side end expansion portion 14, the second side end expansion portion 15 and between two adjacent drug grooves 16 and are located on the outer wall of the balloon component 8.

[0049] In this embodiment, each medicine trough 16 is provided with a rounded slope 17 between its two side edges and the outer wall of the balloon 8. If sharp corners were formed between the two side edges of the medicine trough 16 and the outer wall of the balloon 8, the two side edges of the medicine trough 16 would be squeezed and deformed toward the inside of the medicine trough 16 when the balloon 8 is inflated. The design of the rounded slope 17 replaces the sharp corners to prevent the medicine 13 from getting stuck in the gap between the inner wall of the medicine trough 16 and the two side edges, thereby reducing the loss of the medicine 13 due to blockage. The rounded slope 17 avoids the edges of the medicine trough 16 being too sharp, and the smooth transition design prevents the medicine from getting stuck, reduces the loss of the medicine, and ensures the effective use of the medicine.

[0050] In this embodiment, each drug trough 16 is provided with an expansion and rebound portion 18 located on the inner wall of the balloon member 8, and the expansion and rebound portion 18 is integrally formed with the balloon member 8. When the balloon member 8 is inflated, the gas naturally lifts the expansion and rebound portion 18, thereby discharging all the drug 13 in the drug trough 16 and depositing it on the blood vessel wall. This prevents the drug 13 from accumulating at the bottom of the drug trough 16 and becoming unable to be discharged. The expansion and rebound portion 18 facilitates the complete discharge of the drug 13 in the drug trough 16. As the balloon expands, it deforms, pushing the drug out of the trough, thereby increasing the speed and completeness of drug release.

[0051] In this embodiment, at least two ball caps 12 are bonded to the outer walls of the opposite ends of the two half elastic expansion bodies 9. The outer wall of each ball cap 12 is connected to an elastic pull wire 11. The elastic pull wire 11 is tightened on the outer wall of the half elastic expansion body 9. The opposite ends of the elastic pull wires 11 on the two half elastic expansion bodies 9 are fixedly connected to the first side expansion part 14 and the second side expansion part 15 respectively. When the elastically wrapped expansion body 5 is synchronously expanded and propped up, the first tearable point line 6 is disconnected, causing the two half elastic expansion bodies 9 to retreat backwards under the action of their own elasticity. At the same time, the elastic pull wire 11 elastically pulls the ball cap 12, and the ball cap 12 is connected to the free end of the half elastic expansion body 9. After the half elastic expansion body 9 is disconnected, the elastic pull wire 11 quickly pulls the ball cap 12, causing the two half elastic expansion bodies 9 to be rolled up in opposite directions. The elastic pull wire 11 can further improve the disconnection and retreat efficiency of the half elastic expansion body 9.

[0052] In this embodiment, side medicine pouches 7 are provided at both ends of the balloon member 8 and on the circumferential side of the outer tube 2. The inner ring walls of the two side medicine pouches 7 are integrally connected with a separating ring body 19, and the perforations 20 of the separating ring body 19 are sleeved on the outer tube 2; the side medicine pouches 7 store additional medicine and release it.

[0053] Specifically, the separating ring 19 symmetrically divides the inner ring of the side-end drug pouch 7 into an expansion-engaging cavity 23 and a limited rebound cavity 24. Each expansion-engaging cavity 23 is provided with a second tear-off point 21 on its inner wall, located within the side-end drug pouch 7. The side-end drug pouch 7 contains a drug storage cavity 25 for containing the drug 13. The second tear-off point 21, located within the expansion-engaging cavity 23, controls the opening timing of the side-end drug pouch 7. It breaks under inflation pressure, allowing the drug to flow out of the drug storage cavity 25, achieving a controlled drug release mechanism.

[0054] In this embodiment, the expansion snap-fitting cavities 23 of the two side-end medicine pouches 7 are frictionally snap-fitted to the outer walls of the adjacent first side-end expansion portion 14 and second side-end expansion portion 15, respectively. When the balloon component 8 is inflated, the first side-end expansion portion 14 and the second side-end expansion portion 15 are also inflated. At this time, the first side-end expansion portion 14 and the second side-end expansion portion 15 will squeeze the expansion snap-fitting cavities 23 of the two side-end medicine pouches 7. The inner walls of the two expansion snap-fitting cavities 23 are squeezed and deformed, causing the second tear-off point line 21 to break. At this time, the two side-end medicine pouches 7 have not yet slipped off the first side-end expansion portion 14 and the second side-end expansion portion 15, so the medicine piece 13 will not spill out. Under the squeezing force, the two expansion snap-fitting cavities 23 are gradually squeezed together. The outer walls of the first side end expansion part 14 and the second side end expansion part 15 rub and slide against each other, and when the two halves of the elastic expansion body 9 are stretched open, the two side end medicine bags 7 are completely knocked off the first side end expansion part 14 and the second side end expansion part 15 by the elastic backward reaction force of the half elastic expansion body 9 itself and the elastic pull line 11, and slide down to the side of the outer tube 2. As the side end medicine bag 7 slides down, the medicine piece 13 in the medicine storage cavity 25 is spilled onto the blood vessel wall, and plays a further therapeutic role after the medicine piece 13 on the outer wall of the balloon part 8 is laid.

[0055] Specifically, the elastic pull line 11 pulls the half elastic expansion body 9 to make it shrink quickly, accelerate the retraction speed of the half elastic expansion body 9, speed up the drug release process, and reduce the operation time. The ball head cap 12 fixes the position of the elastic pull line 11 and helps the elastic pull line 11 to better function.

[0056] In this embodiment, two side drug sachets 7 are secured with limit rings 10 on opposite sides of the outer tube 2. These limit rings 10 restrict the movement of the side drug sachets 7 and, in conjunction with the compression springs 22, ensure the correct positioning of the drug sachets, ensuring accurate drug delivery to the targeted area. Multiple compression springs 22 are secured to the outer walls of each separating ring 19 on both sides. The extrusion springs 22 away from the limiting ring 10 elastically abut against the outer walls of the first side end expansion part 14 and the second side end expansion part 15 respectively, while the extrusion springs 22 close to the limiting ring 10 elastically abut against the inner wall of the limiting ring 10. When the side end medicine bag 7 is hit by the half elastic expansion body 9, the elastic pull line 11 and the ball head cap 12, the side end medicine bag 7 will slide around the outer tube 2. At the same time, under the setting of the extrusion springs 22 on both sides, when the side end medicine bag 7 slides, it drives the limiting ring 10 to collide with the first side end expansion part 14, the second side end expansion part 15 and the limiting ring 10, so that the two side end medicine bags 7 will elastically swing back and forth between the limiting ring 10 and the first side end expansion part 14 and the limiting ring 10 and the second side end expansion part 15 respectively, thereby further accelerating the shaking out of the medicine piece 13 from the medicine storage cavity 25, accelerating the discharge of the medicine, and improving the efficiency of the medicine application on the blood vessel wall.

[0057] In this embodiment, when not in use, the elastically wrapped expansion body 5 tightly wraps around the balloon 8, forming a closed structure. This structure protects the drug 13 on the surface of the balloon 8, preventing it from being washed away by blood or prematurely released before reaching the target location. With the help of the outer tube 2 and the guide end tube 3, the entire device is carefully delivered into the patient's vascular system and precisely positioned at the lesion requiring treatment. Once the target location is reached, the doctor injects gas into the balloon 8 through the catheter to cause it to begin expanding. As the volume of the balloon 8 increases, it exerts pressure on the surrounding elastically wrapped expansion body 5. Because the elastically wrapped expansion body 5 has a certain degree of elasticity and ductility, when subjected to pressure from the balloon 8, it is forced to expand outward. During this process, the first tear point line 6 breaks under a predetermined pressure, causing the two halves of the elastic expansion body 9 to separate and roll back, exposing the drug 13 carried by the balloon 8.

[0058] As the elastically wrapped expansion body 5 is opened, the drug piece 13 comes into direct contact with the blood vessel wall. These drugs can be anti-proliferative drugs or other drugs that help prevent restenosis. They will adhere to the blood vessel wall and exert a local therapeutic effect. After the treatment is completed, the doctor will stop inflating the balloon piece 8 and deflate it, and then remove the entire device from the patient's body. At this time, the elastically wrapped expansion body 5 may partially shrink, but its main function has been completed, that is, to ensure that the drug is released at the right time and location. In short, the design of the elastically wrapped expansion body 5 is to ensure that the drug piece 13 can be accurately and effectively delivered to the lesion site, while providing a controllable way to expose and release the drug to achieve the best therapeutic effect.

[0059] In this embodiment, the first tear-off point line 6 is designed to automatically break when the balloon part 8 is inflated and expands, when a certain pressure or expansion degree is reached. Specifically, its disconnection timing and conditions are as follows: when the doctor injects gas into the balloon part 8 through the catheter and the balloon begins to expand, the outer wall of the balloon part 8 will gradually expand outward. As the balloon part 8 expands, it will exert an increasing radial pressure on the elastically wrapped expansion body 5 wrapped around it. This pressure will be transmitted to the first tear-off point line 6. The first tear-off point line 6 is a weak link pre-designed to have strength. When the inflation pressure of the balloon part 8 reaches a preset value, this weak link will not be able to withstand further pressure and will break. Usually, this preset value is carefully calculated based on clinical needs and material properties to ensure that it breaks at the right moment.

[0060] Specifically, once the first break line 6 is severed, the two halves of the elastic expansion body 9 are pushed apart by the continued expansion pressure of the balloon member 8 and retracted in opposite directions, following their own elastic properties. This allows the drug element 13 to be exposed and contact the blood vessel wall, thereby achieving localized drug delivery. In short, the first break line 6 is severed during the inflation process of the balloon member 8, when the balloon expands to a certain degree, that is, when the designed pressure threshold is reached. This ensures that the drug element 13 is released at the optimal time, allowing it to fully contact the lesion site and exert its therapeutic effect.

[0061] In this embodiment, the drug-coated protective component 4 plays a key protective role in the intracranial low-pressure drug-coated balloon dilatation catheter, ensuring that the drug piece 13 will not be washed away by the blood or released prematurely before reaching the target position. The following are the specific steps for the drug-coated protective component 4 to protect the drug: The drug-coated protective component 4 includes an elastically wrapped expansion body 5, which is tightly wrapped around the outer surface of the balloon piece 8 to form a complete closed structure. This closed design can effectively isolate the external environment and avoid direct contact between the drug piece 13 and blood or other body fluids, thereby preventing the drug from dissolving or losing prematurely. The elastically wrapped expansion body 5 is made of a polymer material with good biocompatibility. These materials have good adsorption and stability for drugs. The material needs to be able to resist the physiological environment in the blood vessels, such as enzymes in the blood, pH changes, etc., to ensure that the drug remains active during the delivery process.

[0062] Specifically, the elastically wrapped expandable body 5 provides a physical barrier, protecting the drug from friction and shear forces that may be generated when the catheter moves within the blood vessel. The first tear-off point 6 is a pre-defined weak link, breaking when the balloon 8 inflates to a predetermined pressure. When the first tear-off point 6 breaks, the two halves of the elastic expandable body 9 quickly separate and roll back, exposing the drug 13 and enabling precise drug release.

[0063] Specifically, the elastic pull line 11 is connected to the ball cap 12. When the first tear-off point line 6 breaks, the elastic pull line 11 will quickly pull the ball cap 12 to help the half elastic expansion body 9 separate faster. This mechanism improves the speed and efficiency of drug exposure, ensuring that the drug can contact the lesion site in the shortest time. The drug groove portion 16 is used to store part of the drug part 13 and ensure that it is evenly distributed on the surface of the balloon part 8. The design of the rounded slope portion 17 can prevent the drug from getting stuck at the edge of the drug groove portion 16, ensuring that the drug can be smoothly released from the drug groove. The side drug pouch 7 can provide additional drug storage space at both ends of the balloon part 8 and control the release timing of the drug through the second tear-off point line 21. When the balloon part 8 expands, the drug in the side drug pouch 7 will also be released, further enhancing the local drug concentration and improving the therapeutic effect. Through the above design, the drug coating and protection component 4 not only protects the integrity and activity of the drug part 13 during the transportation process, but also ensures that the drug can be accurately released at the right time and position, thereby achieving the best therapeutic effect.

[0064] Working principle:

[0065] The intracranial low-pressure drug-coated balloon dilatation catheter ensures that all instruments and operating areas are disinfected, the patient is locally anesthetized, and the lesion site is located using imaging equipment such as X-ray, CT or MRI. First, a thin guide wire is sent through the patient's vascular system to the target location, and the outer tube 2 is sent into the blood vessel along the guide wire until it reaches the vicinity of the lesion site. Imaging equipment is used to confirm that the catheter has been correctly placed at the location requiring treatment.

[0066] The guide tube 3 within the outer tube 2 is used to precisely guide the balloon 8 to the affected area. Imaging equipment is then used to confirm that the balloon 8 is positioned correctly at the site of vascular stenosis or occlusion. A syringe connected to the rear end of the outer tube 2 then injects gas into the balloon 8, causing it to begin expanding. As the balloon 8 expands, it exerts pressure on the outer elastic expansion body 5. When the preset pressure threshold is reached, the first tear point 6 breaks, and the two halves of the elastic expansion body 9 separate and roll back, revealing the drug 13 on the surface of the balloon 8.

[0067] The balloon 8 continues to expand, so that the drug 13 directly contacts the vascular wall of the diseased area. The drug components in the drug 13 begin to penetrate into the vascular wall tissue and exert local therapeutic effects, such as inhibiting smooth muscle cell proliferation and preventing restenosis.

[0068] The drug storage cavity 25 inside the side end drug pouch 7 can store additional drugs. When the balloon component 8 is expanded, the first side end expansion portion 14 and the second side end expansion portion 15 will apply pressure to the expansion clamping cavity 23 of the side end drug pouch 7, causing the second tearable point line 21 to break, thereby releasing the drugs stored in the drug storage cavity 25. These additional drugs will further enhance the local drug concentration after the drugs on the outer wall of the balloon component 8 are released, thereby improving the therapeutic effect.

[0069] The elastic pull line 11 helps the half elastic expansion body 9 to reel up quickly after the first tearable point line 6 breaks, accelerating the drug exposure process. The extrusion spring 22 cooperates with the limiting ring 10 to generate a certain vibration when the side drug bag 7 moves, which helps to distribute the drug more evenly on the blood vessel wall.

[0070] After the drug release is completed, the doctor extracts the gas in the balloon member 8 through a syringe to restore the balloon member 8 to its original state, and slowly and carefully withdraws the entire device from the patient's body while monitoring whether any complications occur.

[0071] The patient's vital signs should be closely monitored after surgery to ensure there is no bleeding or other complications. Imaging equipment may be needed for a period of time after surgery to evaluate the effectiveness of treatment.

[0072] It should be noted that, in this article, relational terms such as one and two are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions. The sentence "including an element defined by ... does not exclude the presence of other identical elements in the process, method, article or device that includes the element."

[0073] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A drug-coated balloon dilatation catheter for intracranial hypotension, characterized in that: include: A balloon dilatation catheter assembly (1) comprising an outer tube (2) and a guide end tube (3); A balloon component (8) is fixed to the peripheral outer wall of the outer tube (2) near one end of the guide end tube (3), and the peripheral outer wall of the balloon component (8) has a medicine component (13); The drug coating protection component (4) includes an elastically wrapped expansion body (5) fully enclosed and wrapped around the circumference of the balloon component (8); wherein, when the balloon component (8) is inflated and expanded, it squeezes the elastically wrapped expansion body (5), so that the elastically wrapped expansion body (5) is opened and exposed to expose the drug component (13), and the drug component (13) is applied to the blood vessel wall of the affected part; the elastically wrapped expansion body (5) comprises two symmetrically arranged half elastic expansion bodies (9), and the two half elastic expansion bodies (9) are sealed and connected together at opposite ends through a first tearable point line (6); the balloon component (8) comprises a first side end expansion portion (14) and a second side end expansion portion (15); at least two ball caps (12) are bonded to the outer wall of the opposite ends of the two half elastic expansion bodies (9), and the outer wall of each ball cap (12) is connected to an elastic pull line (11); Side medicine bags (7) are provided at both ends of the balloon component (8) and are located on the circumference of the outer tube (2). The side medicine bags 7 store additional medicine and release it. The inner ring walls of the two side medicine bags (7) are integrally connected with a separation ring body (19). The separation ring body (19) symmetrically divides the inner ring of the side medicine bag (7) into an expansion clamping cavity (23) and a limit rebound cavity (24). Each of the expansion clamping cavities (23) and the inner wall of the side medicine bag (7) has a second tearable point line (21). The inside of the side medicine bag (7) has a medicine storage cavity (25) for containing the medicine component (13).

2. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 1, characterized in that: The two half elastic expansion bodies (9) are arranged to be rolled back in opposite directions on the circumference of the balloon component (8).

3. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 1, characterized in that: The two half elastic expansion bodies (9) are fixedly wrapped at opposite ends to each other on the peripheral outer walls of the first side end expansion portion (14) and the second side end expansion portion (15).

4. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 3, characterized in that: A plurality of medicine grooves (16) are provided in an annular array on the outer wall of the circumference of the balloon member (8) and between the first side end expansion portion (14) and the second side end expansion portion (15); A portion of the drug pieces (13) are stored and accumulated in the drug trough portion (16); Another portion of the drug component (13) is coated between the first side end expansion portion (14), the second side end expansion portion (15), and two adjacent drug groove portions (16) and is located on the outer wall of the balloon component (8).

5. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 4, characterized in that: A rounded slope portion (17) is provided between the two side edges of each medicine groove portion (16) and the outer wall of the balloon component (8).

6. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 5, characterized in that: Each medicine groove portion (16) has an expansion rebound portion (18) on the inner wall of the balloon component (8) and is located behind the medicine groove portion (16). The expansion rebound portion (18) is integrally formed with the balloon component (8).

7. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 6, characterized in that: The elastic pull wire (11) is tightened on the outer wall of the half elastic expansion body (9), and the opposite ends of the elastic pull wires (11) on the two half elastic expansion bodies (9) are fixedly connected to the first side end expansion part (14) and the second side end expansion part (15) respectively.

8. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 7, characterized in that: The through hole (20) of the separating ring body (19) is sleeved on the outer tube (2).

9. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 8, characterized in that: The expansion clamping cavities (23) of the two side end medicine pouches (7) are respectively frictionally clamped on the outer walls of the adjacent first side end expansion portion (14) and the second side end expansion portion (15).

10. The intracranial hypotensive drug-coated balloon dilatation catheter according to claim 9, characterized in that: The two side end medicine bags (7) are located on opposite sides and are located on the periphery of the outer tube (2) and are both fixed with a limiting ring (10). The outer walls on both sides of each separation ring body (19) are fixed with multiple extrusion springs (22).

Images