Conveying type balloon dilatation catheter

Abstract

The utility model discloses a conveying type balloon dilatation catheter which comprises a balloon catheter, a balloon is arranged at the far end of the balloon catheter, a micro catheter is arranged in the balloon catheter, the far end of the micro catheter extends out of the far end of the balloon catheter and penetrates out of the far end of the balloon, and a tip is arranged on a branch pipe body, penetrating out of the far end of the balloon, of the far end of the micro catheter. The far end of the balloon is connected with the far end of the micro catheter in a sealed mode, the near section of the balloon is connected with the far end of the balloon catheter in a sealed mode, a gap is formed between the near section of the balloon and the far end of the balloon catheter to form a filling cavity channel, and the hardness of the balloon catheter and the micro catheter is gradually increased from the far end to the near end. And hydrophilic coatings are coated on the outer surfaces of the balloon catheter and the balloon. Compared with the prior art, the balloon catheter and the micro catheter are combined into a whole, the whole process of balloon dilatation, stent release and balloon post-dilatation is completed in one step, the number of times of exchange of medical instruments in the body of a patient in an operation is reduced, and therefore the possibility of complications of the patient is reduced.

Description

Technical Field

[0001] The utility model relates to a medical device, in particular to a delivery type balloon dilation catheter. Background Art

[0002] With the aging of the population and the change of lifestyle, the number of cerebrovascular disease patients has increased, and the demand for such medical devices has also increased. The vascular lesions are complex, and the proximal and distal sizes, tapered angles, bifurcated lesions, etc. of different blood vessels require a more flexible balloon catheter design to adapt. Traditional balloon catheters have some limitations, such as the need for a high-pressure balloon to perform post-dilation on the stent. The rapid exchange design of the balloon still cannot achieve the single-person completion of the main operations during the surgery. Because after the balloon is dilated, a stent often needs to be further implanted, and the stent microcatheter does not have a rapid exchange design and still requires the overall exchange with the cooperation of two people. Therefore, to truly achieve rapid exchange of all operations, not only a rapidly exchangeable balloon is needed, but also rapidly exchangeable 0.017in microcatheters and 0.021in microcatheters. Clinically, some surgeons have tried to release an intracranial stent through an intracranial balloon (Gateway). Due to the gap between the stent guiding sheath and the balloon hub, it may cause the deformation of the head end of the guiding sheath during the stent delivery process, resulting in the failure to smoothly deliver the stent. Summary of the Utility Model

[0003] The purpose of the utility model is to provide a delivery type balloon dilation catheter, and the technical problem to be solved is to reduce the number of exchanges of instruments during the operation and reduce the possibility of complications.

[0004] To solve the above problems, the utility model is realized by adopting the following technical solutions: A delivery type balloon dilation catheter includes a balloon catheter. The distal end of the balloon catheter has a balloon that can be filled with liquid and expanded. A microcatheter is provided in the balloon catheter. The distal end of the microcatheter extends out of the distal end of the balloon catheter and passes through the distal end of the balloon. A tip is provided on the part of the tube body of the microcatheter where the distal end passes through the distal end of the balloon. The distal end of the balloon is hermetically connected to the distal end of the microcatheter, and the proximal segment of the balloon is hermetically connected to the distal end of the balloon catheter. The balloon catheter and the microcatheter are coaxial, and there is a gap between them to form a filling cavity channel, which is communicated with the inner cavity of the balloon. The lumen of the microcatheter is used to introduce a guide wire or a stent. The tube body hardness of the balloon catheter and the microcatheter gradually increases from the distal end to the proximal end. At least one reinforcing rib is provided in the microcatheter. A hydrophilic coating is applied on the outer surfaces of the balloon catheter and the balloon. At least the part of the tube body of the microcatheter located in the balloon and the tip are provided with radiopaque rings.

[0005] Further, the microcatheter includes a catheter outer layer, a catheter intermediate layer, and a catheter inner layer, and the reinforcing rib is provided in the catheter outer layer, the catheter intermediate layer, or the catheter inner layer.

[0006] Further, the reinforcing rib is provided in the catheter intermediate layer.

[0007] Further, the reinforcing rib is formed by winding at least two strands of fiber filaments.

[0008] Further, the middle layer of the catheter is a braided structure, and the reinforcing rib is interspersed in the braided structure.

[0009] Further, the middle layer of the catheter is formed by braiding at least strands of stainless steel wires.

[0010] Further, the outer layer of the catheter is made of a polymer material other than nylon and nylon in sequence from the distal end to the proximal end.

[0011] Further, the inner layer of the catheter is made of a polymer material.

[0012] Further, at least the proximal tube body of the balloon catheter in the balloon catheter is a double-layer structure section, and the distal tube body is a single-layer structure section.

[0013] Further, the double-layer structure section is composed of a polyimide material located in the inner layer and a polyether block polyamide material located in the outer layer, and the single-layer structure section is made of nylon and a polymer material other than nylon in sequence from the proximal end to the distal end.

[0014] Compared with the prior art, the present utility model realizes the integration of the balloon catheter and the microcatheter by arranging a catheter connected to the balloon in the balloon catheter, and realizes the whole process of balloon dilation, stent release, and post-balloon dilation in one step, reducing the number of exchanges of medical devices in the patient's body during the operation, thereby reducing the possibility of patient complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a schematic diagram of the overall structure of the present utility model.

[0016] Figure 2 is a schematic diagram of the structure between the balloon catheter and the catheter of the present utility model.

[0017] Figure 3 is a schematic diagram of the structure of the balloon catheter of the present utility model.

[0018] Figure 4 is a schematic diagram of the structure of the catheter of the present utility model.

[0019] Figure 5 is Figure 4 a cross-sectional view taken along the A-A direction in DETAILED DESCRIPTION OF THE EMBODIMENTS

[0020] The present utility model will be further described in detail below with reference to the drawings and embodiments.

[0021] In the present utility model, the distal end refers to the end away from the surgical operator; the proximal end refers to the end close to the surgical operator.

[0022] As Figure 1 and Figure 2 shown, the present utility model discloses a delivery type balloon dilation catheter, which is sequentially provided with a catheter hub 14, a stress-relieving tube 15, a balloon catheter 1, a balloon 3, and a tip 8 from the proximal end to the distal end. A microcatheter 2 is coaxially arranged in the balloon catheter 1. The distal end of the microcatheter 2 passes through the distal end of the balloon catheter 1, passes through the balloon 3, and then passes through the distal end of the balloon 3 and is fixedly connected to the tip 8. A through hole communicating with the microcatheter 2 is provided on the tip 8. The distal end of the balloon 3 is hermetically connected to the distal end of the microcatheter 2, and the proximal end of the balloon 3 is hermetically connected to the distal end of the balloon catheter 1. A gap is formed between the microcatheter 2 and the balloon catheter 1 to form a filling channel, and the filling channel communicates with the inner cavity of the balloon 3. The lumen of the microcatheter 2 is used for introducing a guide wire or a stent. The hardness of both the balloon catheter 1 and the microcatheter 2 gradually increases from the distal end to the proximal end, so as to improve the pushing and passing performance of the catheter, reduce the extrusion and collision of the catheter against the blood vessel wall, reduce bleeding and operation difficulty, and increase controllability; at least one reinforcing rib 4 is arranged in the microcatheter 2. The arrangement of the reinforcing rib 4 can enhance the toughness of the catheter and the anti-bending performance. Compared with the traditional process, the "forward slipping" situation is less (that is, suddenly slipping forward significantly when advancing forward), with high safety, good maneuverability, good forward directionality, good supportability, and at the same time reducing the defective rate of the product; a hydrophilic coating is applied on the outer surfaces of the balloon catheter 1 and the balloon 3 to improve the passing performance. A radiopaque ring 9 is provided on the tip 8 and the part of the microcatheter 2 located in the balloon 3. The radiopaque rings located in the balloon 3 are respectively located at the distal end and the proximal end of the balloon 3.

[0023] As Figure 2 and Figure 3 shown, a double-layer structure section 10 is arranged on the proximal tube body of the balloon catheter 1, and the distal tube body is a single-layer structure section 11. Among them, the double-layer structure section 10 is composed of an inner layer 12 and an outer layer 13. The arrangement of the double-layer structure section 10 can enhance the hardness of the proximal tube body and the pushing performance, making the pushing more labor-saving. The inner layer 12 is made of polyimide (PI) material, and the outer layer 13 is made of a polymer material, preferably polyether block polyamide (pebax) material.

[0024] As Figure 2 、 Figure 4 and Figure 5 shown, the microcatheter 2 sequentially includes a catheter outer layer 5, a catheter intermediate layer 6, and a catheter inner layer 7 from the outside to the inside. The reinforcing rib 4 is in the catheter intermediate layer 6.

[0025] In the present utility model, the reinforcing rib 4 is formed by winding two strands of fiber filaments; the middle layer 6 of the catheter is of a braided structure, and the reinforcing rib 4 is inserted into the braided structure. The middle layer 6 of the catheter is formed by braiding 14 strands of stainless steel wires. The reinforcing rib 4 and the middle layer 6 of the catheter are braided into one body, maintaining smoothness, and can also enhance the toughness of the catheter and strengthen the anti-bending performance; the outer layer 5 of the catheter is made of nylon and a polymer material in sequence from the proximal end to the distal end; the inner layer 7 of the catheter is made of a polymer material, preferably made of polytetrafluoroethylene (PTFE) material.

[0026] In the present utility model, the connection between the catheter seat 14 and the stress tube 15, the balloon catheter 1 and the microcatheter 2 adopts the existing technology. Among them, the catheter seat 14 is a catheter seat 14 with two interfaces. The two interfaces on the catheter seat 14 are respectively communicated with the inner cavity of the microcatheter 2 and the inflation channel of the balloon catheter 1. The handle seat 14 can be made of a polymer material, preferably polycarbonate.

[0027] The usage method of the present utility model is as follows: The balloon of the delivery-type balloon dilation catheter enters the vascular stenosis. The hydrophilic coating can improve the lubrication performance of the outer surface of the catheter, and the radiopaque ring can help the doctor accurately locate the position of the catheter in the patient's body. The inflation channel of the delivery-type balloon dilation catheter is pressurized by an external pressure control device, and the balloon at the distal end of the catheter is expanded, thereby expanding the vascular stenosis. Then, due to the negative pressure of the external pressure control device, the balloon is flattened and withdrawn from the original vascular stenosis. At this time, the entire balloon microcatheter does not need to be withdrawn from the patient's body. The balloon-expandable stent is directly advanced distally from the inner cavity of the microcatheter until the balloon-expandable stent reaches the original vascular stenosis. The balloon is expanded by using the pressurization of the external pressure control device to expand and fix the balloon-expandable stent at the original vascular stenosis. Finally, the delivery-type balloon dilation catheter is withdrawn from the patient's body, and the balloon-expandable stent will remain at the original vascular stenosis to keep the blood vessel fully unobstructed.

[0028] The present utility model has the following beneficial effects:

[0029] First, in terms of structure: The delivery-type balloon dilation catheter can complete the whole process of balloon pre-dilation, stent release, and balloon post-dilation in one step, combining the balloon catheter and the microcatheter into one, enabling the balloon-expandable stent or self-expanding stent to be implanted into the vascular stenosis of the patient in one step, reducing the number of exchanges of medical devices in the patient's body during the operation, and thus reducing the possibility of patient complications.

[0030] II. In terms of materials: Almost all of the materials for the inner and outer tubes of traditional delivery balloon dilation catheters are made of the polymer material pebax. The outer tube of our product, the balloon catheter, is composed of a double-layer tube made of the polymer material pebax and polyimide (PI), nylon, and the polymer material pebax from the proximal end to the distal end. Similarly, for the outer layer of the microcatheter, it is composed of nylon and the polymer material pebax from the proximal end to the distal end. Therefore, the hardness and strength of the structure gradually decrease from the proximal end to the distal end, so that the pushing and passing performance of the catheter in actual use is better, reducing the time for the catheter to enter the lesion and the operation difficulty.

[0031] Compared with traditional surgeries, it reduces the instrument exchange, simplifies the operation steps, reduces the fluoroscopy time, reduces the contrast agent dosage, shortens the operation time, reduces the operation risk, and improves the operation safety; compared with the inner and outer tubes of traditional delivery balloon dilation catheters, it speeds up the smoothness of pushing, increases the passing performance, reduces the squeezing and collision force of the catheter on the blood vessel wall, reduces bleeding and operation difficulty, and increases the controllability.

Claims

1. A delivery-type balloon dilatation catheter, comprising a balloon catheter (1), wherein the distal end of the balloon catheter (1) has a liquid-filled and dilatable balloon (3), characterized in that: The balloon catheter (1) is provided with a microcatheter (2), the distal end of the microcatheter (2) extends out of the distal end of the balloon catheter (1) and passes through the distal end of the balloon (3), a tip (8) is provided on the distal end of the microcatheter (2) that passes through the distal end of the balloon (3), the distal end of the balloon (3) is sealedly connected to the distal end of the microcatheter (2), the proximal end of the balloon (3) is sealedly connected to the distal end of the balloon catheter (1), the balloon catheter (1) and the microcatheter (2) are coaxial, and there is a gap between the two. A filling cavity is formed, the filling cavity is connected to the inner cavity of the balloon (3), and the lumen of the microcatheter (2) is used to pass a guide wire or a stent. The hardness of the tube body of the balloon catheter (1) and the microcatheter (2) gradually increases from the distal end to the proximal end. At least one reinforcing rib (4) is provided in the microcatheter (2). A hydrophilic coating is applied on the outer surface of the balloon catheter (1) and the balloon (3). At least a developing ring (9) is provided on the part of the tube body of the microcatheter (2) located in the balloon (3) and on the tip (8).

2. The delivery-type balloon dilatation catheter according to claim 1, characterized in that: The microcatheter (2) comprises a catheter outer layer (5), a catheter middle layer (6) and a catheter inner layer (7), and the reinforcing rib (4) is arranged in the catheter outer layer (5), the catheter middle layer (6) or the catheter inner layer (7).

3. The delivery-type balloon dilatation catheter according to claim 2, characterized in that: The reinforcing ribs (4) are arranged in the middle layer (6) of the conduit.

4. The delivery-type balloon dilatation catheter according to claim 3, characterized in that: The reinforcing rib (4) is formed by winding at least two strands of fiber filaments.

5. The delivery-type balloon dilatation catheter according to claim 4, characterized in that: The catheter middle layer (6) is a braided structure, and the reinforcing ribs (4) are inserted into the braided structure.

6. The delivery-type balloon dilatation catheter according to claim 5, characterized in that: The catheter intermediate layer (6) is woven from at least (14) strands of stainless steel wire.

7. The delivery-type balloon dilatation catheter according to claim 2, characterized in that: The outer layer (5) of the catheter is made of polymer materials other than nylon and nylon in sequence from the distal end to the proximal end.

8. The delivery-type balloon dilatation catheter according to claim 2, characterized in that: The inner layer (7) of the catheter is made of polymer material.

9. The delivery-type balloon dilatation catheter according to claim 1, characterized in that: In the balloon catheter (1), at least the proximal tube body of the balloon catheter (1) is a double-layer structure section (10), and the distal tube body is a single-layer structure section (11).

10. The delivery-type balloon dilatation catheter according to claim 9, characterized in that: The double-layer structure segment (10) is composed of a polyimide material located in the inner layer (12) and a polyether block polyamide material located in the outer layer (13), and the single-layer structure segment (11) is made of nylon and a polymer material other than nylon in sequence from the proximal end to the distal end.

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