Balloon dilatation catheter with drug eluting coating

Abstract

The present application relates to the technical field of balloon dilatation catheter, especially to a balloon dilatation catheter with drug sustained-release coating, which comprises a connecting head, the connecting head is provided with a first interface and a second interface, the connecting head is installed with an outer tube, the connecting head and the outer tube are commonly provided with a guide wire, the outer tube is fixedly connected with a connecting frame, the outer tube is slidingly connected with a sliding cylinder, the sliding cylinder is fixedly connected with a blocking cover, and the connecting frame and the blocking cover are commonly provided with a first air bag, the first air bag is accommodated by the connecting frame and the blocking cover, the drug-loaded first air bag is protected as a whole during the conveying process of the outer tube, the drug-loaded air bag does not directly contact the blood vessel wall during the conveying stage, the drug coating is prevented from being scraped off during the conveying process, meanwhile, the connecting frame and the blocking cover block the first air bag, the blood is separated from the first air bag, the drug amount when reaching the lesion position is ensured, and the drug precision and treatment effect of the lesion position are improved.

Description

Technical Field

[0001] This invention relates to the field of balloon dilation catheter technology, and more particularly to a balloon dilation catheter with a drug-releasing coating. Background Technology

[0002] Drug-eluting balloon catheters are widely used for the dilation and drug delivery of vascular stenosis. Existing drug-eluting coated balloons coat the surface of the balloon with anti-proliferative drugs such as paclitaxel or sirolimus. When the balloon is dilated, the drug is rapidly and evenly delivered to the vessel wall, thereby inhibiting the proliferation and migration of smooth muscle cells and preventing restenosis, thus realizing the treatment concept of "intervention without implantation".

[0003] Its working method requires delivery from the puncture point through a guide sheath to the distal target lesion site. However, this delivery path is usually long and complex. During the delivery process, the drug coating on the surface of the balloon inevitably comes into contact with the blood vessel wall through friction. At the same time, the blood will wash away the drug coating on the surface of the balloon, causing the drug to be lost before reaching the target site. This results in the premature shedding and loss of the drug on the surface. When the balloon reaches the lesion site and completes the dilation and drug delivery, the actual dosage attached to the lesion site is greatly reduced, which directly affects the final treatment effect. Summary of the Invention

[0004] To overcome the disadvantages mentioned in the background above, the present invention provides a balloon dilation catheter with a drug-release coating.

[0005] The technical solution of the present invention is as follows: a balloon dilation catheter with a drug sustained-release coating, comprising a connector, the connector having a first interface and a second interface, an outer tube installed on the connector, a guidewire shared by the connector and the outer tube, the second interface for the guidewire to pass through, a connecting frame fixedly connected to the outer tube, a sliding cylinder slidably connected to the outer tube, a sealing cover fixedly connected to the sliding cylinder, the guidewire sequentially passing through the connector, the outer tube, the sliding cylinder and the sealing cover, a first balloon shared by the connecting frame and the sealing cover, the connecting frame and the sealing cover jointly serving to shield and seal the first balloon, the surface of the first balloon being coated with a drug.

[0006] As a preferred embodiment of the present invention, the first airbag is provided with a first stacking portion and a second stacking portion, wherein the first stacking portion of the first airbag is located on the side closer to the sliding cylinder, and the second stacking portion of the first airbag is located on the side farther away from the sliding cylinder.

[0007] As a preferred embodiment of the present invention, the sealing cover has a guide surface on the side away from the connecting frame.

[0008] As a preferred embodiment of the present invention, a second airbag is provided on the outer side of the connecting frame, and a third airbag is provided on the side of the sealing cover away from the connecting frame. The sealing cover has circumferentially distributed through holes, and the through holes of the sealing cover are used to communicate between the first airbag and the third airbag. The second airbag and the third airbag are used together to seal the blood vessel.

[0009] As a preferred embodiment of the present invention, the surface of the drug on the first airbag is coated with phospholipid to reduce drug friction and shedding.

[0010] As a preferred embodiment of the present invention, the guide wire is equipped with a compression ring, which is used to compress the sealing cover to move.

[0011] As a preferred embodiment of the present invention, it further includes a plurality of protruding posts, which are respectively fixed to the first stacked portion and the second stacked portion of the first airbag. There are several protruding posts in the same group, and the protruding posts are used to reduce the friction between the first stacked portion and the second stacked portion.

[0012] As a preferred embodiment of the present invention, all the protrusions of the first stacked portion of the first airbag are staggered with all the protrusions of the second stacked portion of the first airbag.

[0013] As a preferred embodiment of the present invention, the same group of protruding pillars are obliquely distributed on the first airbag.

[0014] As a preferred embodiment of the present invention, the outer diameter of the sealing cover projected on the side of the connecting frame is greater than the diameter of the largest circumcircle formed by all the protrusions on the first airbag.

[0015] Beneficial effects: This invention uses a connecting frame and a blocking cover to house the first airbag. During the delivery of the drug through the external tube, the first airbag carrying the drug is completely housed and protected. During the delivery stage, the drug-carrying airbag will not directly contact the blood vessel wall, avoiding the drug coating from being scratched off during delivery. At the same time, the connecting frame and the blocking cover block the first airbag, separating the blood from the first airbag, ensuring the amount of drug delivered to the lesion site, and improving the accuracy of drug delivery and the therapeutic effect at the lesion site.

[0016] When the first balloon reaches the lesion site and deploys, the second and third balloons work together to block the blood vessel segment where the first balloon is located, creating a relatively closed local space in that segment of the blood vessel. Within this closed space, the released drug is less likely to be washed away and diluted by the blood flow, resulting in a longer local drug retention time and a higher concentration, thereby improving the therapeutic effect of the drug on the blood vessel wall.

[0017] The protruding posts on the first and second stacked parts of the first airbag significantly reduce the contact area and frictional resistance between the two stacked parts, thereby reducing the mutual scratching of the coatings in the folded state. Attached Figure Description

[0018] Figure 1 This is a three-dimensional structural diagram of the present invention; Figure 2 This is a three-dimensional structural diagram of the connector and outer tube of the present invention; Figure 3 This is a three-dimensional structural diagram of the sealing cover and the first airbag of the present invention; Figure 4 This is a three-dimensional structural diagram of the sliding cylinder and sealing cover of the present invention; Figure 5 This is a three-dimensional structural diagram of the second and third airbags of the present invention; Figure 6 This is a three-dimensional structural diagram of the first airbag of the present invention in its deployed state; Figure 7 This is a three-dimensional structural diagram of the first airbag of the present invention in its inflated state.

[0019] The markings in the diagram are as follows: 1-connector, 101-first interface, 102-second interface, 2-outer tube, 3-guide wire, 4-connector frame, 5-sliding cylinder, 6-sealing cover, 7-first airbag, 8-second airbag, 9-third airbag, 10-compression ring, 11-protrusion. Detailed Implementation

[0020] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the present invention.

[0021] Example 1

[0022] A balloon dilation catheter with a drug-release coating, such as Figures 1-7As shown, the device includes a connector 1 with a first interface 101 and a second interface 102. An outer tube 2 is mounted on the connector 1. A guide wire 3 is provided along the connector 1 and the outer tube 2. The second interface 102 allows the guide wire 3 to pass through. A connecting frame 4 is fixedly connected to the outer tube 2, and a sliding cylinder 5 is slidably connected to the outer tube 2. A sealing cover 6 is fixedly connected to the sliding cylinder 5. The guide wire 3 sequentially passes through the connector 1, the outer tube 2, the sliding cylinder 5, and the sealing cover 6. A first airbag 7 is provided along the connecting frame 4 and the sealing cover 6. The connecting frame 4 and the sealing cover 6 together shield and seal the first airbag 7. The surface of the first airbag 7 is coated with medication. The first airbag 7 has a first stacking portion and a second stacking portion. The first stacked portion of the first airbag 7 is located on the side closer to the sliding cylinder 5, and the second stacked portion of the first airbag 7 is located on the side away from the sliding cylinder 5. The sealing cover 6 has a guide surface on the side away from the connecting frame 4. The second airbag 8 is provided on the outer side of the connecting frame 4, and the third airbag 9 is provided on the side of the sealing cover 6 away from the connecting frame 4. The sealing cover 6 has circumferentially distributed through holes. The through holes of the sealing cover 6 are used to communicate between the first airbag 7 and the third airbag 9. The second airbag 8 and the third airbag 9 are used together to seal the blood vessel. The surface of the drug on the first airbag 7 is coated with phospholipid to reduce drug friction and shedding. The guide wire 3 is equipped with a compression ring 10, which is used to compress the sealing cover 6 to move it.

[0023] In the above scheme, the first interface 101 is used to connect to the air injection pump. The second airbag 8, the first airbag 7, and the third airbag 9 are connected in sequence. The connector 1 and the outer tube 2 together have a first cavity and a second cavity. The first cavity is connected to the second interface 102, and the second cavity is connected to the first interface 101. The first cavity is used to supply the guide wire 3. The second chamber is used for gas flow, and the air pump is used to inflate the first airbag 7, the second airbag 8, and the third airbag 9 through the first interface 101 and the second chamber. The outer tube 2, connecting frame 4, sliding cylinder 5, and sealing cover 6 are all made of medical deformable material. The sealing cover 6 is located on the moving path of the compression ring 10. When the first airbag 7 is deployed, the guide wire 3 drives the compression ring 10 to compress and deploy the sealing cover 6. There is a gap between the first stacked part and the second stacked part of the first airbag 7 when they are stacked, which facilitates the deployment of the first airbag 7. The connecting frame 4 and the sealing cover 6 jointly house the first airbag 7. During the delivery process of the outer tube 2, the drug-loaded first airbag 7 is completely housed and protected. During the delivery stage, the drug-loaded airbag will not directly contact the blood vessel wall, avoiding the drug coating from being scratched off during delivery. At the same time, the connecting frame 4 and the sealing cover 6 seal the first airbag 7, separating the blood from the first airbag 7, ensuring the amount of drug delivered to the lesion site, and improving the accuracy of drug delivery and treatment effect at the lesion site. Figure 4 The central sealing cover 6 and the first airbag 7 are shown in their initial state.

[0024] Working principle: When using this device to administer medication to the vascular lesion site, the medical staff first pass the guide wire 3 through the second interface 102, connector 1, outer tube 2 and sliding cylinder 5 in sequence. Before the guide wire 3 passes through the sealing cover 6 and the compression ring 10 contacts the sealing cover 6, the guide wire 3 stops moving, and the assembly of this device is completed.

[0025] After assembly, medical staff begin interventional procedures, delivering the left side of guidewire 3 and components on the outer tube 2 along the blood vessel lumen (taking a delivery direction to the left as an example) until the occlusion cover 6 approaches the lesion site. At this point, the outer tube 2 and its components stop moving. During this process, the first balloon 7 is housed together by the connecting frame 4 and the occlusion cover 6. During the delivery of the outer tube 2, the drug-loaded first balloon 7 is completely housed and protected. During the delivery phase, the drug-loaded balloon will not directly contact the blood vessel wall, preventing the drug coating from being scratched off during delivery. At the same time, the connecting frame 4 and the occlusion cover 6 seal the first balloon 7, separating the blood from the first balloon 7, ensuring the amount of medication delivered to the lesion site, and improving the accuracy of drug delivery and treatment effect at the lesion site.

[0026] After the outer tube 2 stops moving, the guide wire 3 continues to feed to the left. The compression ring 10 contacts the sealing cover 6, and the compression ring 10 compresses the sealing cover 6. The sealing cover 6 drives the third airbag 9, the sliding cylinder 5, and the left end of the first airbag 7 to move together. During this process, the sliding cylinder 5 slides relative to the outer tube 2, and the first stacked part and the second stacked part of the first airbag 7 adapt to the deformation until the first airbag 7 and the sliding cylinder 5 are aligned. Figure 6 As shown, the first airbag 7 is fully deployed, the sliding cylinder 5 reaches the limit position of the outer tube 2, and the lesion site is located on the periphery of the first airbag 7, and the guidewire 3 stops moving.

[0027] After the guidewire 3 stops moving, the medical staff connects the air pump to the first interface 101 and starts the air pump. Gas is delivered through the first interface 101 to the first balloon 7, the second balloon 8, and the third balloon 9. The first balloon 7, the second balloon 8, and the third balloon 9 inflate synchronously. During the inflation process, the first balloon 7 comes into contact with the lesion site, while the second balloon 8 and the third balloon 9 come into contact with the inner wall of the blood vessel. At this time, the first balloon 7, the second balloon 8, and the third balloon 9 are in a state of... Figure 7In the indicated state, the air pump stops inflating, and the second balloon 8 and the third balloon 9 together block the blood vessel segment where the first balloon 7 is located, creating a relatively closed local space. Within this closed space, the released drug is less likely to be diluted by blood flow, resulting in a longer local drug retention time and higher concentration, thereby improving the therapeutic effect of the drug on the blood vessel wall. After a set time (this time depends on the specific lesion condition and will not be specified here), the first balloon 7 completes the drug delivery to the lesion site. Subsequently, the air pump extracts all the gas from the balloons. During this process, the first balloon 7 loses contact with the lesion site, and the second balloon 8 and the third balloon 9 lose contact with the blood vessel wall until all balloons are completely contracted. Then, the medical staff pulls the outer tube 2 and guide wire 3 to remove the device from the blood vessel cavity. The medical staff then removes the guide wire 3 from the outer tube 2, completing this interventional operation. When the next interventional operation is required, the above operation can be repeated.

[0028] Example 2

[0029] Based on Example 1, such as Figures 4-7 As shown, it also includes several sets of protrusions 11, which are respectively fixed to the first stacked part and the second stacked part of the first airbag 7. The protrusions 11 in the same set are evenly distributed. The protrusions 11 are used to reduce the friction between the first stacked part and the second stacked part. All the protrusions 11 in the first stacked part of the first airbag 7 and all the protrusions 11 in the second stacked part of the first airbag 7 are staggered. The same set of protrusions 11 are inclined on the first airbag 7. The outer diameter of the sealing cover 6 projected on the side of the connecting frame 4 is larger than the diameter of the largest circumscribed circle formed by all the protrusions 11 on the first airbag 7.

[0030] In the above scheme, the first airbag 7 is... Figure 4 In the state shown, the protrusion 11 on the first stacked part of the first airbag 7 supports the second stacked part. When the first airbag 7 is deployed, the protrusion 11 on the first airbag 7 will not cause interference. The protrusion 11 on the second stacked part of the first airbag 7 supports the first stacked part, which greatly reduces the contact area and frictional resistance between the two stacked parts and reduces the mutual scratching of the coatings in the folded state.

[0031] Working principle: When the sealing cover 6 moves the left end of the first airbag 7 to the left, the protruding column 11 moves together with the deformation of the first airbag 7. During this process, the protruding column 11 supports the corresponding stacked parts, which greatly reduces the contact area and frictional resistance between the two stacked parts and reduces the mutual scratching of the coatings in the folded state. At the same time, when the first airbag 7 contacts the lesion site, the protruding column 11 contacts the lesion site first, which can perform point compression on the local lesion site, causing microscopic deformation of the blood vessel wall, which facilitates the penetration effect of drugs.

[0032] Those skilled in the art should understand that the above embodiments do not limit the present invention in any way, and all technical solutions obtained by equivalent substitution or equivalent transformation fall within the protection scope of the present invention.

Claims

1. A balloon dilation catheter with a drug-releasing coating, comprising a connector (1), the connector (1) having a first interface (101) and a second interface (102), an outer tube (2) mounted on the connector (1), a guidewire (3) being provided together with the connector (1) and the outer tube (2), the second interface (102) being for the guidewire (3) to pass through, characterized in that, The outer tube (2) is fixedly connected to a connecting frame (4), the outer tube (2) is slidably connected to a sliding cylinder (5), the sliding cylinder (5) is fixedly connected to a sealing cover (6), the guide wire (3) passes through the connector (1), the outer tube (2), the sliding cylinder (5) and the sealing cover (6) in sequence, the connecting frame (4) and the sealing cover (6) are jointly provided with a first airbag (7), the connecting frame (4) and the sealing cover (6) are used together to shield and seal the first airbag (7), and the surface of the first airbag (7) is coated with medicine.

2. A balloon dilation catheter with a drug-release coating according to claim 1, characterized in that, The first airbag (7) is provided with a first stacked portion and a second stacked portion. The first stacked portion of the first airbag (7) is located on the side close to the sliding cylinder (5), and the second stacked portion of the first airbag (7) is located on the side away from the sliding cylinder (5).

3. A balloon dilation catheter with a drug-release coating according to claim 1, characterized in that, The sealing cover (6) has a guide surface on the side away from the connecting frame (4).

4. A balloon dilation catheter with a drug-release coating according to claim 3, characterized in that, A second airbag (8) is provided on the outer side of the connecting frame (4), and a third airbag (9) is provided on the side of the sealing cover (6) away from the connecting frame (4). The sealing cover (6) has circumferentially distributed through holes. The through holes of the sealing cover (6) are used to communicate between the first airbag (7) and the third airbag (9). The second airbag (8) and the third airbag (9) are used together to seal the blood vessel.

5. A balloon dilation catheter with a drug-release coating according to claim 4, characterized in that, The surface of the drug on the first airbag (7) is coated with phospholipids to reduce drug friction and shedding.

6. A balloon dilation catheter with a drug-release coating according to claim 4, characterized in that, The guide wire (3) is equipped with a compression ring (10), which is used to compress the sealing cover (6) to move.

7. A balloon dilation catheter with a drug-release coating according to claim 5, characterized in that, It also includes several sets of protrusions (11), which are respectively fixed to the first stack and the second stack of the first airbag (7). There are several protrusions (11) in the same set, and the protrusions (11) are used to reduce the friction between the first stack and the second stack.

8. A balloon dilation catheter with a drug-release coating according to claim 7, characterized in that, All the protrusions (11) of the first stack of the first airbag (7) are staggered with all the protrusions (11) of the second stack of the first airbag (7).

9. A balloon dilation catheter with a drug-release coating according to claim 8, characterized in that, The same set of protruding pillars (11) are obliquely distributed on the first airbag (7).

10. A balloon dilation catheter with a drug-release coating according to claim 9, characterized in that, The outer diameter of the sealing cover (6) projected on the side of the connecting frame (4) is greater than the diameter of the largest circumcircle formed by all the protrusions (11) on the first airbag (7).

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