Massage balloon assembly

Abstract

The invention provides a massage balloon assembly, and belongs to the technical field of vascular interventional operation medical instruments, the massage balloon assembly is used for extruding and expanding a blood flow guiding device, the massage balloon assembly comprises a catheter, a balloon is arranged at the position, close to the far end, of the catheter, the catheter is provided with a reducing section, and the diameter of the reducing section is gradually reduced from the near end to the far end; the balloon is arranged on the reducing section; the massage balloon assembly is mainly used for solving the technical problem that due to the fact that an existing massage balloon assembly is large in size, surgical operation is inconvenient.

Description

Technical Field

[0001] The invention belongs to the technical field of medical instruments for vascular intervention surgery, and in particular relates to a massage balloon assembly. Background Art

[0002] In recent years, the emergence of flow diverters (FDs) has provided clinicians and patients with more treatment options for intracranial aneurysm symptoms. The design concept of the flow diverter is to reduce the blood flow between the aneurysm and the parent artery through a higher stent mesh rate, induce thrombosis in the aneurysm, promote intimal hyperplasia at the neck of the aneurysm, thereby achieving the reconstruction of the parent artery and ultimately achieving the goal of aneurysm healing. The appropriate model of the flow diverter is an important factor in ensuring aneurysm occlusion. Only when the implanted flow diverter matches the diameter of the blood vessel can the stent be closely fitted to the vessel wall.

[0003] Therefore, after the blood flow guiding device is released, an X-ray fluoroscopic examination is required to confirm whether the stent is completely attached to the wall or kinked. If there is kinking or incomplete attachment to the wall, the massage balloon assembly needs to be reintroduced, and the massage balloon assembly is inserted into the inner diameter of the blood flow guiding device to expand, squeeze, and rotate the blood flow guiding device to adjust the expansion state of the blood flow guiding device, thereby making the blood flow guiding device fit the blood vessel wall.

[0004] At present, the delivery microcatheter for releasing the blood flow guiding device is usually a microcatheter of model 27 or 21, which has a smaller inner diameter, while the massage balloon assembly is larger in size. If the massage balloon assembly needs to be released, it is usually necessary to withdraw the delivery microcatheter for releasing the blood flow guiding device and then insert another delivery microcatheter with a larger inner diameter to achieve the release of the massage balloon assembly. However, such reciprocating withdrawal and replacement of the delivery microcatheter makes the surgical operation more inconvenient, affects the efficiency of the surgical operation, and increases the risk of infection.

[0005] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0006] The purpose of the present invention is to provide a massage balloon assembly, which mainly solves the technical problem that the existing massage balloon assembly is large in size and causes inconvenience in surgical operation.

[0007] In order to achieve the above-mentioned purpose, the massage balloon assembly of the present invention provides the following technical solutions:

[0008] A massage balloon assembly is used for squeezing and expanding a blood flow guiding device, comprising a catheter, wherein a balloon is arranged near the distal end of the catheter, the catheter has a diameter-changing section, the diameter of the diameter-changing section gradually decreases from the proximal end to the distal end, and the balloon is arranged on the diameter-changing section.

[0009] As a further optimized technical solution, the variable diameter section has cutting grooves arranged along the axial direction to increase the flexibility of the catheter.

[0010] As a further optimized technical solution, the cutting groove is in the shape of a continuous spiral line.

[0011] As a further optimized technical solution, the spiral inclination angle of the cutting groove is set differently in different regions from the proximal end to the distal end, and the spiral inclination angle of the proximal region is greater than that of the distal region.

[0012] As a further optimized technical solution, the variable diameter section has a first area, a second area, a third area, a fourth area and a fifth area which are arranged in sequence from the proximal end to the distal end, and the spiral inclination angles of the first area to the fifth area are 35°-30°-25°-20°-15° respectively, and the pitch of the first area to the fifth area gradually decreases.

[0013] As a further optimized technical solution, the balloon is arranged outside the fourth area, and both ends of the balloon are sealed and fixedly connected to the catheter. The inner cavity of the balloon is connected to the lumen of the catheter through the through hole on the side wall of the catheter, so as to inflate or deflate the balloon through the catheter; the balloon is made of silicone or TPU material with a hardness of 15A, and the elongation of the balloon is 1700-1950%.

[0014] As a further optimized technical solution, heat shrink tubes are respectively sleeved on the outer sides of both ends of the balloon, and the heat shrink tubes partially extend out of the balloon and are sleeved on the outer side of the catheter. The balloon is sealed and fixedly connected to the outer side of the catheter by using the heat shrink tubes.

[0015] As a further optimized technical solution, a developing ring is provided on the catheter to assist the operator in observing the extension status of the balloon catheter.

[0016] As a further optimized technical solution, there are three developing rings, one of which is arranged at the distal end of the catheter, and the other two developing rings are respectively arranged at both ends of the balloon.

[0017] As a further optimized technical solution, the proximal end of the catheter is connected to a handle, and the distal end of the handle is connected to an external stress diffusion tube and an internal stress diffusion tube in sequence. The handle is connected to the catheter through the internal stress diffusion tube, and a blocking ball is provided at the distal end of the catheter to block the lumen at the distal end of the catheter.

[0018] Beneficial effects: In the present application, a variable diameter section is provided on the catheter, and the diameter of the variable diameter section gradually decreases from the proximal end to the distal end, so that the catheter can pass through the delivery microcatheter of the blood flow guiding device. In this way, during the specific operation, there is no need to withdraw the delivery microcatheter of the blood flow guiding device and establish another passage to deliver the balloon. The balloon can be directly delivered through the delivery microcatheter of the blood flow guiding device, thereby effectively improving the convenience and safety of the operation and saving operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0020] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present invention;

[0021] Figure 2 A schematic diagram of the catheter structure of an embodiment of the present invention;

[0022] Figure 3 A schematic diagram of the structure of a catheter portion according to an embodiment of the present invention;

[0023] Figure 4 This is a schematic diagram of the connection between one end of a balloon and a catheter according to an embodiment of the present invention.

[0024] In the figure: 1. catheter; 11. variable diameter section; 111. first area; 112. second area; 113. third area; 114. fourth area; 115. fifth area; 2. balloon; 3. through hole; 4. cutting groove; 5. heat shrink tube; 6. developing ring; 7. handle; 8. external stress diffusion tube; 9. internal stress diffusion tube; 10. sealing ball. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0026] In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, they can be fixed connections or detachable connections; they can be directly connected or indirectly connected through intermediate components. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0027] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0028] The present application provides a massage balloon assembly, which reduces the overall diameter of the catheter to a size that can pass through a microcatheter of model 27 or 21 that delivers a blood flow guiding device by setting a variable diameter section on the catheter, thereby improving the convenience of surgical operations. In addition, by reselecting the material of the balloon, the balloon expansion diameter is made larger, thereby facilitating the adjustment of the release state of the blood flow guiding device.

[0029] Example 1

[0030] like Figure 1 As shown, the massage balloon assembly is used to be input into the inner cavity of the blood flow guiding device to squeeze and expand the blood flow guiding device, so as to fully massage and expand the unexpanded part of the blood flow guiding device, thereby making the blood flow guiding device fit closely with the blood vessel wall.

[0031] Specifically, the massage balloon assembly in the present application has a catheter 1, and the proximal end of the catheter 1 is connected to a handle 7, which is used to connect an external operating device. The distal end of the handle 7 is connected to an external stress diffusion tube 8 and an internal stress diffusion tube 9 in sequence, and the handle 7 is connected to the catheter 1 through the internal stress diffusion tube 8, so that the driving force of the operating handle 7 is conveniently transmitted to the catheter 1 through the external stress diffusion tube 8 and the internal stress diffusion tube 9. A blocking ball 10 formed by curing with UV glue is provided at the distal end of the catheter 1 to block the lumen at the distal end of the catheter 1 to prevent the flow medium injected into the lumen of the catheter 1 from the proximal end from flowing out from the distal end. At the same time, the blocking ball 10 formed by curing with UV glue is smooth and soft, which can avoid puncturing the blood vessel during the process of delivering the catheter 1 to the blood vessel.

[0032] A balloon 2 is provided near the distal end of the catheter 1, and the balloon 2 can be expanded to squeeze and massage the blood flow guide device. In the present application, the catheter 1 has a variable diameter section 11, and the variable diameter section 11 is specifically machined by grinding to gradually reduce the diameter from the proximal end to the distal end into a shape with a certain taper. The proximal diameter of the variable diameter section 11 is 0.35 mm, the distal diameter is 0.25 mm, and the overall length of the variable diameter section 11 is 200 mm. In other embodiments, the variable diameter section 11 can be processed into a plurality of equal diameter sections with gradually reduced diameters that are fixedly connected in sequence to achieve the purpose of the invention that the diameter of the variable diameter section 11 as a whole is gradually reduced from the proximal end to the distal end.

[0033] In order to increase the flexibility of the catheter 1, the variable diameter section 11 has a cutting groove 4 arranged along the axial direction. Specifically in this embodiment, the cutting groove 4 is a continuous spiral shape. In other embodiments, the cutting groove 4 can also be an intermittently arranged arc groove, as long as it can increase the flexibility of the variable diameter section 11. Any shape of the cutting groove 4 is acceptable.

[0034] like Figure 2 , Figure 3 As shown, the spiral inclination angle of the cutting groove 4 is set differently in different regions from the proximal end to the distal end. It should be noted here that "differently set in different regions" means that the diameter-changing section 11 has a first region 111, a second region 112, a third region 113, a fourth region 114 and a fifth region 115 which are sequentially connected and arranged from the proximal end to the distal end, and the spiral inclination angle of the cutting groove 4 on each region is the same in the region, but different from the spiral inclination angle of the cutting groove 4 in any other region. And the spiral inclination angle of the proximal region is greater than that of the distal region.

[0035] In this embodiment, the spiral inclination angles of the first region 111 to the fifth region 115 are 35°-30°-25°-20°-15° respectively, and the pitch of the first region 111 to the fifth region 115 gradually decreases. In this way, the cutting groove 4 of the variable diameter section 11 is gradually encrypted from the proximal end to the distal end, so that the flexibility can be gradually increased from the proximal end to the distal end, further improving the ability of the distal end of the catheter 1 to adapt to curved blood vessels, thereby making it more convenient to push the balloon 2.

[0036] Furthermore, a balloon 2 is installed at a position 10 mm away from the distal end on the fourth region 114 of the variable diameter section 11. At the same time, the balloon 2 is arranged outside the fourth region 114, and both ends of the balloon 2 are sealed and fixedly connected to the catheter 1. The inner cavity of the balloon 2 is connected to the lumen of the catheter 1 through three groups of elliptical through holes 3 on the side wall of the catheter 1. Each group of through holes 3 is evenly arranged around the axial direction of the catheter 1. That is, the angle between any two adjacent through holes 3 is 120°. In this way, a liquid or gas-like flowing medium can be injected into the lumen of the catheter 1 to fill the balloon 2. When the balloon 2 is used up, the gas or liquid injected into the catheter 1 can be discharged to shrink the balloon 2, that is, the through holes 3 are used to fill or shrink the balloon 2 through the catheter 1.

[0037] In this embodiment, the balloon 2 is made of 15A hardness silicone or TPU material, and the elongation of the balloon 2 is 1700-1950%, so that the maximum filling diameter of the balloon 2 can reach 5mm or more, which is more convenient for massaging and expanding the blood flow guiding device.

[0038] like Figure 4 As shown, heat shrink tubes 5 are respectively sleeved on the outer sides of both ends of the balloon 2, and the heat shrink tubes 5 partially extend out of the balloon 2 and sleeved on the outer side of the catheter 1. The balloon 2 is sealed and fixedly connected to the outer side of the catheter 1 by using the heat shrink tubes 5. Specifically, the PTFE heat shrink tube 5 shrinks under the condition of 400±10°C, and the ends of the balloon 2 are sealed and fixedly connected to the catheter 1. After fixation, the wall thickness of the PTFE heat shrink tube 5 is only 0.05mm, which will not affect the flexibility of the catheter 1.

[0039] Furthermore, in order to facilitate the operator to observe the extension state of the catheter 1 of the balloon 2 in the blood vessel, a developing ring 6 is provided on the catheter 1. In this embodiment, there are three developing rings 6, one developing ring 6 is provided at the distal end of the catheter 1 to observe the position of the catheter 1, and the other two developing rings 6 are provided at both ends of the balloon 2 to confirm that the balloon 2 is located at the narrow position of the blood flow guiding device after being filled.

[0040] In summary, in the present application, a variable diameter section 11 is provided on the catheter 1 so that the catheter 1 can be used as a universal delivery microcatheter of a blood flow guiding device. In this way, during a specific operation, there is no need to additionally withdraw the delivery microcatheter of the blood flow guiding device, and the balloon 2 can be directly delivered through the delivery microcatheter of the blood flow guiding device, thereby effectively improving the convenience and safety of the operation and saving operation time.

[0041] It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

[0042] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims

1. A massage balloon assembly for squeezing and expanding a blood flow guiding device, comprising a catheter (1), wherein a balloon (2) is arranged near the distal end of the catheter (1), characterized in that: The catheter (1) has a diameter-reducing section (11), the diameter of which gradually decreases from the proximal end to the distal end, and the balloon (2) is arranged on the diameter-reducing section (11).

2. The massage balloon assembly according to claim 1, characterized in that: The diameter-changing section (11) is provided with cutting grooves (4) arranged along the axial direction to increase the flexibility of the catheter (1).

3. The massage balloon assembly according to claim 2, characterized in that: The cutting groove (4) is in the shape of a continuous spiral line.

4. The massage balloon assembly according to claim 3, characterized in that: The spiral inclination angle of the cutting groove (4) is set differently in different regions from the proximal end to the distal end, and the spiral inclination angle of the proximal end region is greater than the spiral inclination angle of the distal end region.

5. The massage balloon assembly according to claim 4, characterized in that: The variable diameter section (11) comprises a first region (111), a second region (112), a third region (113), a fourth region (114) and a fifth region (115) which are arranged in sequence from the proximal end to the distal end, the helical inclination angles of the first region (111) to the fifth region (115) are 35°-30°-25°-20°-15° respectively, and the helical pitches of the first region (111) to the fifth region (115) gradually decrease.

6. The massage balloon assembly according to claim 5, characterized in that: The balloon (2) is arranged outside the fourth region (114), and both ends of the balloon (2) are sealed and fixedly connected to the catheter (1). The inner cavity of the balloon (2) is connected to the lumen of the catheter (1) through a through hole (3) on the side wall of the catheter (1), so as to fill or shrink the balloon (2) through the catheter (1); the balloon (2) is made of silicone or TPU material with a hardness of 15A, and the elongation of the balloon (2) is 1700-1950%.

7. The massage balloon assembly according to any one of claims 1 to 6, characterized in that: Heat shrink tubes (5) are respectively sleeved on the outer sides of both ends of the balloon (2); the heat shrink tubes (5) partially extend out of the balloon (2) and are sleeved on the outer side of the catheter (1); the balloon (2) is sealed and fixedly connected to the outer side of the catheter (1) by using the heat shrink tubes (5).

8. The massage balloon assembly according to any one of claims 1 to 6, characterized in that: The catheter (1) is provided with a developing ring (6) for assisting an operator in observing the extension state of the catheter (1) of the balloon (2).

9. The massage balloon assembly according to claim 8, characterized in that: There are three developing rings (6), one of which is arranged at the distal end of the catheter (1), and the other two developing rings (6) are respectively arranged at the two ends of the balloon (2).

10. The massage balloon assembly according to any one of claims 1 to 6, characterized in that: The proximal end of the catheter (1) is connected to a handle (7), and the distal end of the handle (7) is connected to an external stress diffusion tube (8) and an internal stress diffusion tube (9) in sequence. The handle (7) is connected to the catheter (1) via the internal stress diffusion tube (9), and a blocking ball (10) is provided at the distal end of the catheter (1) to block the lumen at the distal end of the catheter (1).

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