Bundling balloon dilatation device

Abstract

The invention relates to a cluster balloon dilatation device which is formed by sequentially connecting a tip, a cluster balloon, a tube cavity, a push rod and a handle seat, the cluster balloon is composed of at least two symmetrical single balloons, and a shared wall is arranged between every two adjacent single balloons; the tube cavity is of a double-layer tubular cavity structure composed of an outer tube and an inner tube, and the far end of the inner tube is axially arranged in the center of the bundling balloon. The near end of the single bag is communicated with the far end of the push rod through the outer tube. Compared with the prior art, the high-pressure dilatation balloon adopts an acute-angle-free structure, is suitable for being used in a human body lumen, realizes high-pressure dilatation by selecting any single balloon under the condition of one-time interventional therapy, reduces damage to a blood vessel wall when the balloon and a guide wire are replaced in an operation, has independence in compliance of each single balloon, and can be switched and selected according to needs; in addition, gaps are reserved between the single sacs of the cluster balloon, unexpected tearing of blood vessels or tissues in the expansion process can be effectively avoided, the effectiveness and safety of the structure are improved, and pain and decoction in and after an operation of a patient are reduced.

Description

Technical Field

[0001] The present invention relates to a balloon dilation catheter, and in particular to a cluster balloon dilation device, belonging to the technical field of medical devices. Background Art

[0002] With the continuous increase in the number of patients with embolism in the heart, brain and peripheral cavities, the impact of thrombosis on humans is becoming greater and is gradually getting younger. Rapid opening of complex calcified lesions is an essential means for treating patients and a prerequisite for subsequent treatment of interventional surgery. Ensuring the patency of the human circulation during the opening or establishment of the cavity is a necessary condition for maintaining the normal operation of the diseased organ and the upstream and downstream organs. However, existing single-balloon and other devices on the market cannot establish an effective channel in a cavity with hard or sharp blockages. Especially for some complex calcified lesions, when severe calcification occurs on a single surface of a blood vessel, ordinary single-balloon dilation cannot effectively open the blood vessel passage, and the use of rotational atherectomy is likely to tear the blood vessel on the better surface.

[0003] Therefore, it is extremely urgent to design a balloon dilation structure that can selectively open complex calcified lesions. Summary of the Invention

[0004] The present invention provides a cluster balloon dilation device, which solves the problem of difficult blood vessel opening in the prior art when severe calcification occurs on a single surface of a blood vessel with complex calcified lesions. The cluster balloon dilation device is suitable for various cavity blockages in the human body, maximizing the application effect of the device and ensuring the optimal treatment of patients during the surgical process. The technical solution is as follows: The cluster balloon dilation device is successively connected and composed of a tip, a cluster balloon, a lumen, a push rod and a handle base. The cluster balloon is symmetrically composed of at least 2 single balloons, and there is a common wall between adjacent single balloons; the lumen is a double-layer tubular cavity structure composed of an outer tube and an inner tube, and the distal end of the inner tube is axially arranged at the center of the cluster balloon; the proximal end of the single balloon is communicated with the distal end of the push rod through the outer tube.

[0005] Further, the cluster balloon is symmetrically composed of at most 5 single balloons. If the number exceeds this amount, it will affect the constricted outer diameter and passability of the cluster balloon, making it difficult to reach the lesion site.

[0006] Further, the number of cavity channels formed by the outer tube and the push rod is less than or equal to the number of single balloons.

[0007] Further, the proximal end of the push rod is connected to the distal end of the handle.

[0008] Further, a pressure injection port is arranged on the handle and communicated with the single balloon.

[0009] Further, the diameter and compliance of each single balloon are the same.

[0010] Furthermore, the diameter and compliance of each single balloon are different.

[0011] Furthermore, there are gaps between the single balloons, and the width of the gaps is 0.05 mm - 0.8 mm. If the gaps are too small, the effect of dispersing the force when the dispersive balloon dilates the blood vessel cannot be achieved, and it is easy to cause blood vessel tearing. If the gaps are too large, the problem that some lesions in the blood vessel cannot be dilated smoothly will occur.

[0012] The outer tube is radially provided with a rapid exchange port communicating with the tip provided at the distal end of the cluster balloon. The rapid exchange guide wire is inserted from the tip 2 and passes out through the rapid exchange port 9.

[0013] Compared with the prior art, the beneficial effects of the present invention are as follows: The entire cluster balloon dilation device adopts a structure without acute angles, which is suitable for use in the human lumen. Under the condition of a single interventional treatment, any single balloon can be selected for high-pressure dilation, reducing the damage to the blood vessel wall when replacing the balloon and the guide wire during the operation. For problems such as complex calcified lesions, the single balloon on the severely calcified surface can be dilated separately according to clinical needs. The compliance of each single balloon is independent and can be switched and selected according to needs. It can establish and open the lumen in various blocked lumens with hard, sharp, and irregular foreign bodies. Moreover, there are gaps between the single balloons of the cluster balloon, which can effectively avoid unexpected tearing of blood vessels or tissues during the dilation process, improving the effectiveness and safety of the structure, being easy to operate, providing a more secure surgical operation process basis for the operator, increasing the treatment means of the operator, and reducing the pain and suffering of the patient during and after the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0015] Figure 1 It is a schematic structural diagram of the cluster balloon dilation device; Figure 2 It is a schematic cross-sectional diagram of the cluster balloon structure; In the figure: 1. Cluster balloon, 2. Tip, 3. Inner tube, 4. Outer tube, 5. Pushing rod, 6. Handle, 7. Single balloon, 8. Common wall, 9. Rapid exchange port. Embodiment

[0016] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention. Embodiment

[0017] As Figure 1 shown, the clustered balloon dilation device is composed of a tip 2, a clustered balloon 1, a lumen, a push rod 5, and a handle 6. The clustered balloon 1 is composed of two single balloons 7. There is at least one common wall 8 between adjacent single balloons 7, and the single balloon 7 is circular. The tip 2 is located at the distal end of the clustered balloon 1. The inner tube 3 is axially arranged at the center of the clustered balloon 1. The lumen includes an outer tube 4 and the inner tube 3. The outer tube 4 is on the outer layer of the inner tube 3. The proximal end of the clustered balloon 1 is communicated with the distal end of the push rod 5 through the outer tube 4. The number of channels of the push rod 5 and the outer tube 4 is less than or equal to the number of single balloons 7. The proximal end of the push rod 5 is connected to the handle 6. Embodiment

[0018] During use, a rapid exchange guide wire is inserted from the tip 2 and passes out through the rapid exchange port 9. The push rod 5 is pushed to track the guide wire so that the clustered balloon dilation device reaches the lesion site. The handle 6 is connected to a stamping device for stamping to expand the clustered balloon 1 to the required diameter. During the process, if a calcified hard lesion is found, the interface of the handle 6 can be switched to select any single balloon for dilation, because each single balloon has its own independent pressurizing interface, and different single balloons can be pressurized at the handle end to achieve the effect of blood vessel dilation and opening. After the dilation is completed, the pressure is released, and the device can be withdrawn from the body along the guide wire. Embodiment

[0019] The inner tube 3 is arranged at the axis of the clustered balloon 1 to ensure that the entire clustered balloon is not eccentric. Embodiment

[0020] The compliance of each single balloon 7 can be the same compliance, or a combination of compliance and non-compliance, etc. The different surfaces of the clustered balloon can be expanded to different pressures as needed to solve the problem of severe calcification on some lesion surfaces. Embodiment

[0021] When the number of inner cavities of the push rod 5 is equal to the number of single balloons 7, any single balloon can be selected for stamping and dilation, and the pressures of different single balloons can be controlled separately. Embodiment

[0022] When the number of inner cavities of the push rod 5 is less than the number of single balloons 7, the reduction of the inner cavities reduces the pleated outer diameter of the product and improves the product's passability. The missing inner cavities are compensated by the compliance of the single balloon 7 itself, so that the single balloon can reach the expansion diameter under a certain pressure even without a separate inner cavity. Embodiment

[0023] For the cluster balloon dilation device, the nominal diameter and compliance of each single balloon have independent properties, and different surfaces of the cluster balloon dilation device can be dilated to different pressures according to needs to solve the problem of severe calcification on some lesion surfaces. Embodiment

[0024] When the number of inner cavities of the push rod is less than or equal to the number of single balloons, any single balloon can be selected for stamping and dilation. Embodiment

[0025] The single balloon is circular, oval, gourd-shaped or other shapes, which can maintain the stability of the expanded shape of the single balloon. Embodiment

[0026] The lumen is made of a polymer pipe material, and the single balloon is made of a polymer material. Embodiment

[0027] As Figure 2 shown, when the number of single balloons is 2, the single balloon is gourd-shaped, and the convex parts on both sides of the single balloon are in contact to form a common wall, and there is a gap in the middle concave part; when the number of single balloons is 3, the single balloon is circular and connected in a triangular shape, and each single balloon is in contact with the adjacent two single balloons respectively to form a common wall, and there is a gap in the middle of the 3 single balloons; when the number of single balloons is 5, the single balloon is circular and connected in a cross shape, and each single balloon is in contact with the single balloon in the middle to form a common wall, and there is a gap between the circumferentially adjacent single balloons.

[0028] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. Cluster balloon dilation device, which is composed of a tip, a cluster balloon, a lumen, a push rod and a handle base connected in sequence, characterized in that, The clustered balloon (1) is symmetrically composed of at least two single balloons (7), and there is a shared wall between adjacent single balloons; the lumen is a double-layer tubular cavity structure composed of an outer tube (4) and an inner tube (3), and the distal end of the inner tube (3) is axially arranged at the center of the clustered balloon (1); the proximal end of the single balloon (7) is communicated with the distal end of the push rod (5) through the outer tube (4).

2. The cluster balloon dilation device according to claim 1, wherein The clustered balloon (1) is symmetrically composed of at most five single balloons (7).

3. The cluster balloon dilation device according to claim 1, wherein The number of cavity channels formed by the outer tube (4) and the push rod (5) is less than or equal to the number of single balloons (7).

4. The cluster balloon dilation device according to claim 1, characterized in that The proximal end of the push rod (5) is connected to the distal end of the handle (6).

5. The cluster balloon dilation device according to claim 1, characterized in that, A pressure injection interface is arranged on the handle (6) and communicated with the single balloon (7).

6. The cluster balloon dilation device according to claim 1, wherein Each of the single balloons (7) has the same diameter and compliance.

7. The cluster balloon dilation device according to claim 1, wherein Each of the single balloons (7) has different diameters and compliances.

8. The cluster balloon dilation device according to claim 1, wherein There are gaps between the single balloons (7), and the width of the gaps is 0.05 mm - 0.8 mm.

9. The cluster balloon dilation device according to claim 1, wherein, The outer tube (4) is radially provided with a rapid exchange port (9) which is communicated with the tip (2) arranged at the distal end of the clustered balloon (1).

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