Special-shaped balloon

Abstract

The special-shaped balloon comprises a catheter seat, a three-cavity middle rod, an outer-layer balloon body and an inner-layer balloon body, a protrusion is arranged on the surface of the outer-layer balloon body in the circumferential direction and comprises a protrusion root portion and a protrusion top portion, the two ends of the protrusion root portion are connected with the protrusion top portion and the outer-layer balloon body respectively, and when the outer-layer balloon body is in an expansion state, the protrusion root portion is connected with the protrusion top portion and the inner-layer balloon body. The top of each protrusion is in close contact with the adjacent top of each protrusion, and a gap exists between the root of each protrusion and the adjacent root of each protrusion. The special-shaped balloon disclosed by the invention can be used for expanding a narrow part of a blood vessel, and blood can pass through a formed channel to reach the far end of the blood vessel, so that the blood blocking time and the blocking amount of the narrow blood vessel are effectively reduced, the ischemic injury of an organism is reduced, the operative complications are reduced, and the prognosis of a patient is improved.

Description

Technical Field

[0001] The invention relates to a medical balloon, in particular to a special-shaped balloon, and belongs to the field of medical devices. Background Art

[0002] With the advancement of science and technology, my country's medical industry has continued to develop, and technical means such as luminal implant interventional treatment have also been rapidly developed. With the advantage of less trauma, it has gradually replaced the "traditional" surgical method. At present, percutaneous coronary artery implant intervention has a history of more than 40 years, and cerebrovascular implant intervention has a history of more than 30 years in my country. It is widely used in the treatment of human lumen stenosis such as coronary atherosclerosis and ischemic stroke, which can effectively improve arterial blood flow and relieve symptoms such as ischemia. Implantation is to place a metal stent in the narrow part of the blood vessel to expand and recanalize the narrowed and occluded blood vessels or cavities. During the stent placement process, a balloon needs to be used for post-expansion to make it fit into the narrow lumen. If the stent is not completely fitted with the inner wall of the lumen, the incidence of stent restenosis will increase significantly, especially for patients with underlying diseases such as hypertension, hyperlipidemia, and hyperglycemia. It is necessary to extend the balloon post-expansion time to make the stent fit better with the inner wall of the lesion lumen. The conventional device for post-stent dilatation is an ordinary balloon dilatation catheter, which completely blocks the blood vessel during the dilatation process, and blood flow cannot reach the distal end of the blood vessel, which can easily cause irreversible ischemic damage. Interventional surgery is to deliver a balloon catheter or a drug balloon to the narrowed part of the blood vessel. A large pressure is required to expand the balloon so that the balloon can fit the inner wall of the lesion cavity completely. However, blood will be blocked during the dilatation process. Long-term blockage may cause ischemic damage to important organs and increase the cavity pressure of the lesion. The surgical risk is increased and the patient's prognosis is poor.

[0003] With the arrival of an aging population in my country, the requirements for the safety of cavity treatment surgery are constantly increasing, and higher requirements are also placed on treatment equipment. Therefore, there is an urgent need for a special-shaped balloon that does not block blood flow.

[0004] The invention patent with application publication number CN114832216A discloses a single-chamber perfusion balloon dilatation catheter, which adopts a special structural design of a single-chamber support balloon composed of an outer annular cylinder and an inner annular cylinder on a prefabricated special-shaped balloon and has a circular ring-shaped cross-section after being fully expanded. The support balloon with an internal annular columnar hollow chamber and an end tube running through the middle of the support balloon form a blood flow channel with an annular cross-section to achieve the perfusion function. However, this patent can only achieve the perfusion of external blood, and cannot allow the blood in the blood vessel segment itself to pass through, and the cavity pressure in the diseased area cannot be effectively released.

[0005] The invention patent with the publication number of CN103949003A discloses an expandable non - occlusive balloon catheter and its preparation method. The balloon edge of this patent has two or three petals, forming one or three hollow channels, so that the expanded balloon will not completely block the blood vessel segment, and the blood still maintains a flowing state. However, this patent adopts a single - layer balloon design, with poor pressure resistance and anti - deformation ability, and is prone to deformation and blockage of the hollow channel in a severely stenotic lumen. Summary of the Invention

[0006] To solve the above - mentioned technical problems, the present invention discloses a special - shaped balloon, and the technical solution is as follows: A special - shaped balloon, comprising a catheter hub, a three - lumen intermediate rod, an outer balloon and an inner balloon. The outer balloon is circumferentially provided with protrusions on its surface. The protrusions include a protrusion root and a protrusion top. Both ends of the protrusion root are respectively connected to the protrusion top and the outer balloon. When the outer balloon is in an expanded state, the protrusion tops are in close contact with adjacent protrusion tops, and there is a gap between adjacent protrusion roots.

[0007] The three - lumen intermediate rod includes three concentric channels, which are the first channel, the second channel and the third channel in sequence from inside to outside. The proximal end of the three - lumen intermediate rod is connected to the catheter hub. The distal end of the second channel communicates with the cavity of the inner balloon, and the distal end of the third channel communicates with the cavity of the outer balloon. The inner balloon is located inside the outer balloon.

[0008] The catheter hub is provided with a first cavity, a second cavity, a third cavity and a three - lumen channel. The three - lumen channel communicates with the first cavity, the second cavity and the third cavity. The proximal end of the three - lumen intermediate rod is inserted into the three - lumen channel. The first channel communicates with the first cavity, the second channel communicates with the second cavity, and the third channel communicates with the third cavity.

[0009] The protrusion top is an umbrella - shaped structure or an inverted multi - frustum structure. Preferably, it is an inverted multi - frustum structure, which has better support performance.

[0010] The protrusion root is a cube, or a cylinder, or a cone, or a triangular prism.

[0011] The protrusion is provided with a nail - shaped cavity. The nail head of the nail - shaped cavity is located at the protrusion top, the nail body of the nail - shaped cavity is located at the protrusion root, and the nail tip of the nail - shaped cavity communicates with the cavity of the outer balloon.

[0012] The interval between adjacent protrusions is 0.1 mm - 30 mm. The protrusion interval can ensure that when in an expanded state, a space (i.e., a blood channel) is formed between the protrusion roots to allow blood to pass through.

[0013] The upper limit of the protrusion is the maximum value determined according to the diameter of the human body lumen.

[0014] The outer surface of the top of the protrusion is smooth, the top of the protrusion has a certain curvature towards the outside, and the surface area of the top of the protrusion towards the outside is 0.01 mm 2 -900 mm 2 , and the surface area of the top of the protrusion is adjusted according to the interval distance to ensure close contact of the top of the protrusion during balloon dilation.

[0015] A third-layer balloon is provided between the outer balloon and the inner balloon.

[0016] Holes are provided on the surface of the outer balloon and the protrusion.

[0017] The surface of the outer balloon and the protrusion can be coated with a coating.

[0018] The coating is a drug coating or a polymer film coating.

[0019] Compared with the prior art, its beneficial effects are as follows: During use, the outer balloon is delivered to the vascular stenosis site. First, the inner balloon is filled to the required diameter through the second channel, and the outer balloon is pre-dilated by the supporting force of the inner balloon. Then, the outer balloon is dilated through the third channel, and the protrusion expands accordingly. When the outer balloon is in the expanded state and is squeezed by external pressure, the protrusion is not easily deformed and can maintain its original shape. When the outer balloon is fully dilated, the tops of the protrusions are tightly clustered into a seamless platform, and several channels are formed between the roots. The seamless platform formed by the tops of the protrusions can be used to uniformly and effectively dilate the vascular stenosis site, and the several channels formed by the roots of the protrusions can allow the blood flowing in the blood vessel to pass through. The blood reaches the distal end of the blood vessel, effectively reducing the blood blockage time and blockage volume of the stenotic blood vessel, reducing ischemic injury of the body, reducing surgical complications, and improving the prognosis of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a schematic diagram of the overall structure; Figure 2 is Figure 1 an enlarged schematic diagram of part A in Figure 3 is Figure 1 an enlarged schematic diagram of part B in Figure 4 is a schematic diagram of the structure of 31 - protrusion root and 32 - protrusion top in Embodiment 1; Figure 5 is a schematic diagram of the structure of 33 - blood channel in Embodiment 1; Figure 6 is a schematic diagram of the structure of 31 - protrusion root and 32 - protrusion top in Embodiment 2; Figure 7It is a schematic diagram of the 33-blood channel structure in Embodiment 2; In the figure: 1. catheter seat; 2. three-chamber intermediate rod, 21. first channel, 22. second channel, 23. third channel; 3. outer balloon, 31. bulge root, 32. bulge top, 33. blood channel; 4. inner balloon. Embodiment

[0021] The technical solution of the present invention will be further described in combination with the accompanying drawings and specific embodiments. The following embodiments are only specific embodiments of the present invention and do not limit the usage mode of the present invention. Embodiment

[0022] A special-shaped balloon, with an outer balloon diameter of 8 mm and a length of 20 mm. Protrusions are arranged at intervals of 5 mm along the effective length direction of the balloon and at intervals of 3.14 mm along the circumferential direction of the balloon, with a total of 32 protrusions. The bulge top is an umbrella-shaped structure, 5 mm long and 3.14 mm wide towards the outside, 1 mm long and 1 mm wide towards the inside, and the vertical height is 2 mm. The bulge root is located directly below the top and is a cube with a length, width, and height of 1 mm. The inner balloon has a diameter of 6 mm and a length of 18 mm. The inner balloon communicates with the second channel, and the outer balloon communicates with the third channel.

[0023] During the doctor's use, the balloon is delivered to the vascular stenosis site. The inner balloon is rapidly expanded through the second channel, and the outer balloon is supported. The outer balloon is filled to 10 atm through the third channel, and the protrusions rapidly expand. The bulge tops tightly cluster into a seamless platform and contact the inner wall of the stenosis section lumen, maintaining for 30 s to fully expand the stenosis site. During the expansion process, 8 hollow channels are formed at the bulge roots, penetrating the proximal and distal ends of the diseased blood vessel. The total cross-sectional area of the hollow channels is 51.36 mm 2 , assuming the blood flow velocity of this blood vessel is 100 cm / s, a total of 154.08 ml of blood flows through during the entire expansion process, reaching the distal end of the blood vessel, effectively reducing the ischemic injury of the body. Embodiment

[0024] A special-shaped balloon, with an outer balloon diameter of 12 mm and a length of 30 mm. A total of 6 protrusions penetrating the effective length direction of the balloon are arranged at intervals of 6.28 mm along the circumferential direction of the balloon. The bulge top is an umbrella-shaped structure, 30 mm long and 6.28 mm wide towards the outside, 30 mm long and 2 mm wide towards the inside, and the vertical height is 2 mm. The bulge root is located directly below the top, 30 mm long, 2 mm wide, and 3 mm high. The inner balloon has a diameter of 11 mm and a length of 28 mm. The surface of the outer balloon is coated with a rapamycin drug coating. The inner balloon communicates with the second channel, and the outer balloon communicates with the third channel.

[0025] During the doctor's use, the balloon is delivered to the vascular stenosis site. The inner balloon is rapidly expanded through the second channel, and the outer balloon is supported. The outer balloon is filled to 4 atm through the third channel, and the protrusions rapidly expand. The tops of the protrusions tightly cluster into a seamless platform that contacts the inner wall of the stenosis segment lumen, and the stenosis site is expanded for 60 s, allowing the rapamycin drug coating to fully adhere to the wall. During the expansion process, 6 hollow channels are formed at the roots of the protrusions. The total cross-sectional area of the hollow channels is 128.40 mm 2 , assuming the blood flow velocity in the blood vessel is 50 cm / s, a total of 385.20 ml of blood flows through during the entire expansion process, reaching the distal end of the blood vessel and effectively reducing the ischemic injury of the body. Embodiment

[0026] A special-shaped balloon, wherein the outer balloon is provided with protrusions penetrating the effective length direction of the balloon at intervals along the circumferential direction of the balloon. The top of the protrusion is an inverted frustum structure, and the outer surface area of the top of the protrusion facing outward is 0.01 mm 2 . The outer balloon surface is coated with a rapamycin drug coating. The inner balloon communicates with the second channel, and the outer balloon communicates with the third channel.

[0027] During the doctor's use, the balloon is delivered to the vascular stenosis site. The inner balloon is rapidly expanded through the second channel, and the outer balloon is supported. The outer balloon is filled through the third channel, and the protrusions rapidly expand. The tops of the protrusions tightly cluster into a seamless platform that contacts the inner wall of the stenosis segment lumen, and the stenosis site is expanded, allowing the rapamycin drug coating to fully adhere to the wall. During the expansion process, the space left between the roots of the protrusions forms hollow channels, and the blood reaches the distal end of the blood vessel through the hollow channels, effectively reducing the ischemic injury of the body. Embodiment

[0028] A special-shaped balloon, wherein the outer balloon is provided with protrusions penetrating the effective length direction of the balloon at intervals along the circumferential direction of the balloon. The top of the protrusion is an inverted frustum structure, which has better support performance and can resist stronger external extrusion forces, keeping the space (i.e., the blood channel) unchanged in shape and unobstructed for blood passage. The outer surface area of the top of the protrusion facing outward is 900 mm 2 . The outer balloon surface is coated with a rapamycin drug coating. The inner balloon communicates with the second channel, and the outer balloon communicates with the third channel.

[0029] During the doctor's use, the balloon is delivered to the vascular stenosis site. The inner balloon is rapidly expanded through the second channel, and the outer balloon is supported. The outer balloon is filled through the third channel, and the protrusions rapidly expand. The tops of the protrusions tightly cluster into a seamless platform that contacts the inner wall of the stenosis segment lumen, and the stenosis site is expanded, allowing the rapamycin drug coating to fully adhere to the wall. During the expansion process, the space left between the roots of the protrusions forms hollow channels, and the blood reaches the distal end of the blood vessel through the hollow channels, effectively reducing the ischemic injury of the body.

[0030] Above, specific descriptions of the general embodiments of the present invention have been given. Without creative efforts, other embodiments can also be obtained through the above embodiments, and all are within the protection scope of the present invention.

Claims

1. A special-shaped balloon, comprising a catheter seat (1), a three-lumen intermediate rod (2), an outer balloon (3) and an inner balloon (4), characterized in that, The outer balloon (3) is provided with protrusions circumferentially spaced on its surface. The protrusions include a protrusion root (31) and a protrusion top (32). The protrusion top (32) communicates with the outer balloon (3) through the protrusion root (31). When the outer balloon (3) is in an expanded state, two adjacent protrusion tops (32) are in close contact, and there is a space between two adjacent protrusion roots (31).

2. The special-shaped balloon according to claim 1, characterized in that, The three - lumen intermediate rod (2) includes three concentric channels, which are, from the inside to the outside, the first channel (21), the second channel (22), and the third channel (23) in sequence. The proximal end of the three - lumen intermediate rod (2) is connected to the catheter hub (1). The distal end of the second channel (22) communicates with the cavity of the inner balloon (4), and the distal end of the third channel (23) communicates with the cavity of the outer balloon (3). The inner balloon (4) is located inside the outer balloon (3).

3. The special-shaped balloon according to claim 2, wherein, The catheter hub (1) is provided with a first cavity, a second cavity, a third cavity, and a three - lumen channel. The three - lumen channel communicates with the first cavity, the second cavity, and the third cavity. The proximal end of the three - lumen intermediate rod (2) is inserted into the three - lumen channel. The first channel (21) communicates with the first cavity, the second channel (22) communicates with the second cavity, and the third channel (23) communicates with the third cavity.

4. The special-shaped balloon according to claim 1, characterized in that, The protrusion top (32) is an umbrella - shaped structure or an inverted multi - frustum structure.

5. The special-shaped balloon according to claim 3, wherein, The inside of the protrusion is a nail - shaped cavity structure. The nail head of the nail - shaped cavity is located at the protrusion top (32), the nail body of the nail - shaped cavity is located at the protrusion root (31), and the tip of the nail - shaped cavity communicates with the cavity inside the outer balloon (3).

6. The special-shaped balloon according to claim 1, characterized in that, The interval between the protrusion and the adjacent protrusion is 0.1 mm - 30 mm.

7. The special-shaped balloon according to claim 1, characterized in that, The outer surface of the top of the protrusion (32) is smooth, the top of the protrusion (32) has a certain curvature towards the outside, and the surface area of the top of the protrusion (32) towards the outside is 0.01 mm 2 - 900 mm 2 .

8. A special-shaped balloon according to claim 1, characterized in that, A third - layer balloon is provided between the outer balloon and the inner balloon.

9. A special-shaped balloon according to claim 1, characterized in that, The outer balloon (3) and the surface of the protrusion are provided with holes.

10. A special-shaped balloon according to claim 8, characterized in that, The outer balloon (3) and the surface of the protrusion can be coated with a coating.

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