Self-tearing drug balloon catheter

Abstract

The utility model discloses a self-tearing medicine balloon catheter which comprises a catheter body. A balloon main body is arranged outside the catheter, the balloon main body comprises a filling layer, a rupture layer is arranged outside the filling layer, and a space between the rupture layer and the filling layer serves as a medicine storage cavity; a tearing path is preset on the surface of the rupture layer, and the tearing path is used for enabling the rupture layer to rupture after the filling layer expands, so that the medicine in the medicine storage cavity is released. The medicine storage layer and the tearing layer are designed on the outer surface of the balloon, and the tearing layer can be torn actively in the balloon expansion process, so that medicine is released to the inner wall of a blood vessel, meanwhile, falling of the medicine on the surface in the balloon conveying process can be reduced, and the treatment effect on a target position is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical machinery, in particular to a self-tearing drug balloon catheter. Background Art

[0002] Ischemic cerebrovascular disease is caused by damage to the blood vessel walls, changes in blood composition, or abnormal hemodynamics, which lead to obstruction of blood supply to the brain. This disease can cause necrosis or softening of brain tissue in the blood supply area due to ischemia and hypoxia, resulting in short-term or long-term local or extensive damage, and then triggering a series of neurological impairments. As one of the three major causes of human death, ischemic cerebrovascular disease has attracted much attention due to its high morbidity, high disability rate, and high mortality rate. After extensive clinical verification abroad, drug balloon delivery drug therapy has shown significant advantages in resolving intravascular stenosis. Compared with other treatment methods, drug balloon therapy can effectively reduce the restenosis rate of blood vessels and stents, and will not cause a series of complications such as inflammation of the inner wall of the blood vessel.

[0003] Current drug-eluting balloon structures generally spray the drug onto the balloon surface. After the balloon reaches the lesion site, it is inflated so that the outer surface of the balloon contacts the inner wall of the blood vessel, thereby releasing the drug and inhibiting the proliferation of the inner wall of the blood vessel. According to clinical statistics, the drug release process generally takes 20 seconds to 2 minutes. However, the intracranial blood vessels are relatively tortuous and complex. The drug coating sprayed on the outer wall of the balloon is prone to drug loss during delivery through the balloon catheter, resulting in a reduction in drug dosage. In clinical practice, longer filling times are often required to ensure therapeutic effects. However, due to the poor tolerance of intracranial tissue to ischemia and other conditions, prolonged balloon filling will have adverse effects on the tissues behind the blood vessels, such as continuous pressure on surrounding tissues, which may lead to tissue ischemia, necrosis, or fibrosis. This compression may also affect the normal function of nerves, blood vessels, or organs, but if the balloon filling time is too short, it will not achieve a good therapeutic effect. Utility Model Content

[0004] The purpose of the present utility model is to solve the above problems and provide a self-tearing drug balloon catheter.

[0005] In order to achieve the above-mentioned purpose, the present invention specifically adopts the following technical solutions:

[0006] A self-tearing drug balloon catheter, comprising:

[0007] catheter;

[0008] The catheter is provided with a balloon body on the outside, the balloon body including a filling layer, a rupture layer is provided on the outside of the filling layer, and the space between the rupture layer and the filling layer serves as a drug storage cavity;

[0009] A tearing path is preset on the surface of the rupture layer, and the tearing path is used to rupture the rupture layer after the filling layer expands, so as to release the medicine in the medicine storage cavity.

[0010] As a further description of the above technical solution, the balloon body is composed of a plurality of independent petal-shaped balloon units surrounding the catheter, and each of the petal-shaped balloon units includes a filling layer, a rupture layer, and a tearing path arranged on the surface of the rupture layer.

[0011] As a further description of the above technical solution, a plurality of filling channels are opened inside the catheter, and each of the filling channels is connected to the corresponding filling layer.

[0012] As a further description of the above technical solution, the tearing path is opened along the axial direction of the valve-shaped balloon unit or in a direction perpendicular to the axial direction.

[0013] As a further description of the above technical solution, a suture line is preset on the tearing path.

[0014] As a further description of the above technical solution, the material of the rupture layer is polylactic acid and polycaprolactone.

[0015] As a further description of the above technical solution, the surface of the filling layer is in a folded state in an initial state, and the grooves in the filling layer in the folded state are used to fix the medicine.

[0016] As a further description of the above technical solution, the shape of each balloon petal unit is the same. The beneficial effects of the present invention are as follows:

[0017] 1. The utility model designs a drug storage layer and a tear layer on the outer surface of the balloon. The tear layer can be actively torn during the balloon expansion process, thereby releasing the drug to the inner wall of the blood vessel. At the same time, it can reduce the shedding of the surface drug during the balloon delivery process and improve the treatment effect on the target location.

[0018] 2. The utility model adopts a multi-valve design through the balloon. After the balloon reaches the target position, only the balloon valve at the lesion position needs to be expanded, and the remaining non-expanded parts can ensure blood flow, overcoming the problem of poor tolerance of intracranial tissue to ischemia.

[0019] In order to more clearly illustrate the structural features and functions of the present invention, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of a self-tearing drug-eluting balloon catheter;

[0021] Figure 2 is a cross-sectional view of a balloon catheter;

[0022] Figure 3 This is a schematic diagram of a partially inflated valve-shaped balloon unit in a balloon catheter;

[0023] Figure 4 Schematic diagram of the valve-shaped balloon unit.

[0024] Figure numerals: 1. catheter; 2. filling layer; 3. rupture layer; 4. drug storage cavity; 5. tear path; 6. valve-shaped balloon unit; 7. filling channel. DETAILED DESCRIPTION

[0025] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention.

[0026] like Figure 1-Figure 4 As shown, in one embodiment, a self-tearing drug balloon catheter 1 includes a catheter 1, and a filling channel is provided between the inner wall and the outer wall of the catheter 1. A filling medium such as physiological saline can be introduced into the filling channel to fill the balloon body, thereby allowing the drug on the balloon to approach the target position. Specifically, the filling medium is filled into the filling layer 2 in the balloon body through the filling channel to achieve the expansion of the balloon.

[0027] A rupture layer 3 is disposed outside the filling layer 2, and the space between the filling layer 2 and the rupture layer 3 constitutes the drug storage cavity 4. Specifically, the rupture layer 3, which can be referred to as a rupturable layer 3, has a pre-set tear path 5 on its surface. When the balloon body is in its uninflated state, the rupture layer 3 has low surface tension and, therefore, the tear path 5 will not rupture. Consequently, the drug disposed between the filling layer 2 and the rupture layer 3 will not be exposed, effectively reducing the risk of drug loss during delivery of the drug balloon through tortuous and narrow blood vessels. After the drug balloon is delivered to the treatment site, filling fluid is introduced through the filling channel, causing the filling layer 2 to expand, and the external rupture layer 3 to expand accordingly. After expanding to a certain extent, the rupture layer 3 ruptures along the tear path 5, releasing the drug within and enabling treatment of the target site.

[0028] In summary, by providing a rupture layer 3 on the outer surface of the balloon and providing drugs inside the rupture layer 3, the problem of excessive loss of surface drugs during balloon delivery, which affects the treatment effect, can be reduced.

[0029] Please continue reading Figure 3, as for the entire balloon body, it is composed of several independent flap-like balloon units 6 arranged around the catheter 1. In this embodiment, the size and shape of each flap-like balloon unit 6 are the same, while in other feasible embodiments, the size and shape of each flap-like balloon unit 6 may be different and adjusted according to actual needs. Mutual independence here means that each flap-like balloon unit 6 is connected to the filling layer 2 through a filling channel, and a rupture layer 3 is provided on the filling layer 2 of each flap-like balloon unit 6, and a tearing path 5 is opened on each rupture layer 3. Therefore, when in use, if only a part of the area in the blood vessel needs to be treated, after the drug balloon is transported to the target position, the filling medium is filled into the flap-like balloon unit 6 near the target area to expand the flap-like balloon unit 6, while the other flap-like balloon units 6 remain in an unexpanded state. In short, after the balloon is in place, only the balloon at the target treatment position needs to be inflated. The remaining non-expanded part can ensure blood circulation and reduce the continuous pressure on the surrounding tissues due to the long-term inflation of the balloon, which may lead to tissue ischemia, necrosis or fibrosis.

[0030] Please continue reading Figure 4 In this embodiment, the tear path 5 is formed along the axial direction of the valve-shaped balloon unit 6. When the rupture layer 3 ruptures, the tear path 5 is formed along the axial direction to expose the internal drug, so that the internal drug can be evenly released, thereby better achieving treatment of the target location. In other feasible embodiments, the tear path 5 can also be formed in a direction perpendicular to the axial direction (not shown in the figure), as long as the drug can be released after the tearing.

[0031] Furthermore, a suture (not shown) can be provided along the tear path 5. This suture prevents premature tearing of the drug balloon during delivery or during the gradual expansion of the balloon body, effectively reducing drug shedding during delivery. The suture should possess sufficient strength and toughness, and the material should be biocompatible, thus reducing vascular irritation and inflammatory responses. Meanwhile, the material of the rupture layer 3 can be polylactic acid (PLA) or polycaprolactone (PCL), which are biodegradable materials with good biocompatibility and drug release properties.

[0032] See also Figure 2 The surface of the filling layer 2 within the balloon body is initially folded. This folded state contains multiple grooves that secure the drug. After the filling layer 2 expands, the grooves gradually disappear, releasing the drug. Even if the tear path 5 of the rupture layer 3 opens prematurely during drug delivery, the grooves secure the drug, reducing the likelihood of drug loss and enhancing the therapeutic effect at the target site.

[0033] The above description of the disclosed embodiments will enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A self-tearing drug balloon catheter, characterized in that: include: catheter; The catheter is provided with a balloon body on the outside, the balloon body including a filling layer, a rupture layer is provided on the outside of the filling layer, and the space between the rupture layer and the filling layer serves as a drug storage cavity; A tearing path is preset on the surface of the rupture layer, and the tearing path is used to rupture the rupture layer after the filling layer expands, so as to release the medicine in the medicine storage cavity.

2. The self-tearing drug balloon catheter according to claim 1, characterized in that: The balloon body is composed of a plurality of mutually independent petal-shaped balloon units surrounding the catheter, and each of the petal-shaped balloon units includes a filling layer, a rupture layer, and a tearing path arranged on the surface of the rupture layer.

3. The self-tearing drug balloon catheter according to claim 1, characterized in that: A plurality of filling channels are provided inside the catheter, and each of the filling channels is communicated with the corresponding filling layer.

4. The self-tearing drug balloon catheter according to claim 2, characterized in that: The tearing path is opened along the axial direction of the valve-shaped balloon unit or in a direction perpendicular to the axial direction.

5. The self-tearing drug balloon catheter according to claim 4, characterized in that: A suture line is preset on the tearing path.

6. The self-tearing drug balloon catheter according to claim 1, characterized in that: The surface of the filling layer is in a folded state in an initial state, and the grooves in the filling layer in the folded state are used to fix the medicine.

7. The self-tearing drug balloon catheter according to claim 2, characterized in that: Each of the balloon petal-shaped units has the same shape.

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