Spinal process free-floating balloon catheter

Abstract

The application discloses a spinous process anti-loose balloon catheter, which comprises an inner tube, a tip tube, an outer tube, a balloon unit, a proximal fixed sleeve, a proximal movable sleeve, a distal sleeve and three spinous process ribs, the distal end of the spinous process rib is fixedly connected with the distal sleeve, the proximal end of the spinous process rib is fixedly connected with the proximal movable sleeve, the distal sleeve is fixedly connected with the tip tube, the proximal movable sleeve is penetrated by the outer tube and can move relative to the outer tube, the proximal fixed sleeve is fixedly connected with the outer tube, and an elastic belt is arranged between the proximal end of each spinous process rib and the proximal fixed sleeve. When the balloon catheter of the application is inflated, the spinous process ribs can be in a normal state and the balloon is extruded, and when the balloon is depressurized, the spinous process ribs can be effectively constrained, which is favorable for the withdrawal of the balloon.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a spinous process-protected balloon catheter. Background Technology

[0002] The spinous balloon dilatation catheter is a medical device used for vascular interventional therapy. It uses spinous ridges (scribing wires) on the outer surface of the balloon to directionally scribble and cut calcified plaques or fibrotic lesions in the blood vessel when the balloon is inflated, thereby reducing the risk of dissection caused by simple balloon dilation and improving dilation efficiency.

[0003] In existing technologies, a spinous process balloon typically includes a balloon body, a catheter, and a spinous process assembly structure. The spinous process assembly structure consists of a spinous process ridge and circular sleeves fixed at both ends. The two circular sleeves are respectively fixedly connected to the outer tube and the tip tube, allowing the spinous process ridge to span the working section of the balloon and adhere to the outer surface of the balloon. In its factory-folded state, the balloon undergoes multi-wing folding (such as a three-wing fold), with the spinous process ridge contained within the balloon's folds. At this point, the spinous process ridge is constrained by the folds, resulting in good catheter insertion and passage.

[0004] However, in existing technologies, the spinous ridge is typically fixed only at points via circular cannulas at both ends, with no binding constraint between the middle working section and the outer surface of the balloon. When the balloon reaches the lesion and inflates, the balloon flaps unfold, and the middle section of the spinous ridge becomes free. Since the cross-section of the spinous ridge is usually an equilateral triangle (with its apex as a cutting edge), the free spinous ridge is prone to the following problems during balloon inflation:

[0005] First, the spinous process can flip. The spinous process of a triangular cross-section can flip in its free state, causing the cutting edge, which should be facing the vessel wall, to turn towards the balloon body, or even the base towards the vessel wall. In this case, the spinous process reduces the compression effect on the vessel wall and instead compresses the balloon, resulting in a significant decrease in dilation efficiency.

[0006] Secondly, the spinous process ridge cannot be reset during balloon decompression and retraction. After the balloon completes inflation and retracts, the spinous process ridge is exposed on the outer surface of the balloon in an irregular posture. During catheter retraction, the spinous process ridge may become disordered and cannot be restrained, significantly increasing the risk and difficulty of operation, and making it more difficult to successfully withdraw the catheter. Summary of the Invention

[0007] Purpose of the invention: This application aims to overcome the deficiencies of the prior art and provide a spinous process-preventing balloon catheter.

[0008] Technical solution: A spinous process-preventing balloon catheter, comprising an inner tube, a tip tube, an outer tube, a balloon unit, a proximal fixed cannula, a proximal movable cannula, a distal cannula, and three spinous process ridges. The distal end of each spinous process ridge is fixedly connected to the distal cannula, the proximal end of each spinous process ridge is fixedly connected to the proximal movable cannula, the distal cannula is fixedly connected to the tip tube, the proximal movable cannula is passed through the outer tube and can move relative to the outer tube, and the proximal fixed cannula is fixedly connected to the outer tube. An elastic band connects the proximal end of each spinous process ridge to the proximal fixed cannula.

[0009] Furthermore, the proximal fixing sleeve is welded to the outer tube, and the distal sleeve is welded to the tip tube.

[0010] Furthermore, the tip tube is welded and fixed to the inner tube.

[0011] Furthermore, the distal end of the elastic band is welded and fixed to the spinous process ridge, and the proximal end is welded and fixed to the proximal fixing sleeve.

[0012] Furthermore, the elastic band is made of a thermoplastic elastomer material.

[0013] Furthermore, the thermoplastic elastomer material is polyether block amide (PEBAX) or thermoplastic polyurethane (TPU).

[0014] Furthermore, the balloon unit includes a balloon body, a proximal tube connected to the balloon body, and a distal tube connected to the balloon body. The distal tube is fixedly connected to the distal end of the inner tube, and the proximal tube is fixedly connected to the distal end of the outer tube.

[0015] Furthermore, the proximal pin is welded and fixed to the outer tube, and the distal pin is welded and fixed to the inner tube.

[0016] Furthermore, the spinous process ridge is not fixedly connected to the proximal tube pin, the balloon body, or the distal tube pin.

[0017] Furthermore, the front ends of the tip tube and the inner tube are welded and fixed.

[0018] Furthermore, the inner tube is located inside the outer tube.

[0019] Furthermore, the proximal end of the spinous ridge has a stepped portion, the distal end of the elastic band is fixedly connected to the stepped portion, and the proximal end is fixedly connected to the proximal end fixing sleeve.

[0020] Furthermore, the elastic band is flat.

[0021] Furthermore, a first protrusion is fixed to the surface of the outer tube of the elastic band, the first protrusion having a first perforation, and a first elastic rope passing through the first perforation is connected between the proximal end of each ridge and the proximal end fixing sleeve.

[0022] Furthermore, the distal end of the first elastic rope is welded and fixed to the spinous process ridge, and the proximal end is welded and fixed to the proximal fixing sleeve.

[0023] Furthermore, the first elastic cord is made of a thermoplastic elastomer material.

[0024] Furthermore, the thermoplastic elastomer material is polyether block amide (PEBAX) or thermoplastic polyurethane (TPU).

[0025] Furthermore, two of the first protrusions are fixed at each elastic band.

[0026] Furthermore, a second protrusion is fixed on both sides of the spinous ridge, and a second through hole is provided at the second protrusion. Three sets of elastic limiting units are connected between the distal sleeve and the proximal fixing sleeve. Each set of elastic limiting units includes two second elastic ropes. The proximal end of the second elastic rope is connected to the proximal fixing sleeve, and the distal end is connected to the distal sleeve. The second elastic rope passes through the second through hole.

[0027] Furthermore, the distal end of the second elastic rope is welded and fixed to the distal end sleeve, and the proximal end is welded and fixed to the proximal end fixing sleeve.

[0028] Furthermore, the second elastic cord is made of a thermoplastic elastomer material.

[0029] Furthermore, the thermoplastic elastomer material is polyether block amide (PEBAX) or thermoplastic polyurethane (TPU).

[0030] Beneficial effects: Compared with the prior art, the balloon catheter of this application has the following advantages:

[0031] 1. Through the coordinated repositioning and restraint of the elastic band and the first elastic cord, the spinous ridge can be pulled back and closely adhere to the outer surface of the balloon during balloon decompression and contraction, maintaining a regular posture without disorder. This improves the safety and smoothness of catheter retraction.

[0032] 2. Through the limiting effect of the second elastic cord during balloon inflation, the spinous process ridge is stably constrained in the preset position during expansion. The two second elastic cords on both sides of the spinous process ridge can effectively prevent the spinous process ridge from flipping over, ensuring that the equilateral triangular cutting edge of the spinous process ridge always faces the blood vessel wall. Attached Figure Description

[0033] Figure 1 This is a first-view schematic diagram of the balloon catheter in Example 1;

[0034] Figure 2 This is a second-view schematic diagram of the balloon catheter in Example 1;

[0035] Figure 3This is a first-view schematic diagram of the balloon catheter in Example 2;

[0036] Figure 4 This is a second-view schematic diagram of the balloon catheter in Example 2. Detailed Implementation

[0037] Reference numerals: 1 Inner tube; 2 Outer tube; 3 Tip tube; 4.1 Distal tube leg; 4.2 Proximal tube leg; 4.3 Balloon body;

[0038] 5.1 Distal cannula; 5.2 Proximal movable cannula; 5.3 Proximal fixed cannula; 5.4 Spike ridge; 5.4.1 Stepped portion; 5.4.2 Second protrusion; 5.5 Elastic band; 5.5.1 First protrusion; 5.6 First elastic cord; 5.7 Second elastic cord.

[0039] Example 1

[0040] like Figure 1 , 2 As shown, a spinous process-preventing balloon catheter includes an inner tube 1, a tip tube 3, an outer tube 2, a balloon unit, a proximal fixed cannula 5.3, a proximal movable cannula 5.2, a distal cannula 5.1, and three spinous process ridges 5.4. The distal end of each spinous process ridge 5.4 is fixedly connected to the distal cannula 5.1, and the proximal end of each spinous process ridge 5.4 is fixedly connected to the proximal movable cannula 5.2. The distal cannula 5.1 is fixedly connected to the tip tube 3. The proximal movable cannula 5.2 is passed through the outer tube 2 and is movable relative to the outer tube 2. The proximal fixed cannula 5.3 is fixedly connected to the outer tube 2. An elastic band 5.5 connects the proximal end of each spinous process ridge 5.4 to the proximal fixed cannula 5.3. The proximal fixed cannula 5.3 is welded to the outer tube 2, and the distal cannula 5.1 is welded to the tip tube 3. The tip tube 3 is welded to the inner tube 1. The balloon unit includes a balloon body 4.3, a proximal tube 4.2 connected to the balloon body 4.3, and a distal tube 4.1 connected to the balloon body 4.3. The distal tube 4.1 is fixedly connected to the distal end of the inner tube 1, and the proximal tube 4.2 is fixedly connected to the distal end of the outer tube 2. The proximal end of the spinous ridge 5.4 has a stepped portion 5.4.1, the distal end of the elastic band 5.5 is fixedly connected to the stepped portion 5.4.1, and the proximal end is fixedly connected to the proximal fixing sleeve 5.3. The elastic band 5.5 is flat; a first protrusion 5.5.1 is fixed on the surface of the elastic band 5.5 facing the outer tube 2. The first protrusion 5.5.1 has a first perforation, and a first elastic cord 5.6 passing through the first perforation connects the proximal end of each spinous ridge 5.4 and the proximal fixing sleeve 5.2. Two of the first protrusions 5.5.1 are fixed at each elastic band 5.5.

[0041] The spinous process balloon of this application features a spinous process ridge enclosed within the balloon's flaps during deployment, allowing for excellent overall balloon catheter advancement. Furthermore, the tip of the spinous process balloon is not significantly different from traditional spinous process balloons, maintaining good advanceability. When the balloon inflates, the balloon body expands, compressing the spinous process ridge. This causes the proximal movable cannula to move towards the proximal foot of the balloon, while the positions of the proximal fixed cannula and the outer tube remain fixed. As the proximal movable cannula moves away from the proximal fixed cannula, the elastic band is stretched, resulting in better contact and engagement between the spinous process ridge and the balloon body under the tension of the elastic band.

[0042] As the medium inside the balloon is subsequently aspirated and the balloon deflates, the elastic bands shorten and reposition themselves. This causes the proximal movable cannula to move towards the proximal fixed cannula. Under the action of the three elastic bands, the spinous ridge remains attached to the balloon body, preventing it from becoming loose or slipping. Furthermore, during this process, the first elastic cord assists in the movement of the proximal movable cannula towards the proximal fixed cannula while simultaneously ensuring the elastic bands adhere to the outer tube. This better aligns the proximal components of the balloon with the outer tube, facilitating balloon catheter withdrawal.

[0043] Example 2

[0044] like Figure 3 , 4As shown, a spinous process-preventing balloon catheter includes an inner tube 1, a tip tube 3, an outer tube 2, a balloon unit, a proximal fixed cannula 5.3, a proximal movable cannula 5.2, a distal cannula 5.1, and three spinous process ridges 5.4. The distal end of each spinous process ridge 5.4 is fixedly connected to the distal cannula 5.1, and the proximal end of each spinous process ridge 5.4 is fixedly connected to the proximal movable cannula 5.2. The distal cannula 5.1 is fixedly connected to the tip tube 3. The proximal movable cannula 5.2 is passed through the outer tube 2 and is movable relative to the outer tube 2. The proximal fixed cannula 5.3 is fixedly connected to the outer tube 2. An elastic band 5.5 connects the proximal end of each spinous process ridge 5.1 to the proximal fixed cannula 5.3. The proximal fixed cannula 5.3 is welded to the outer tube 2, and the distal cannula 5.1 is welded to the tip tube 3. The tip tube 3 is welded to the inner tube 1. The balloon unit includes a balloon body 4.3, a proximal tube 4.2 connected to the balloon body 4.3, and a distal tube 4.1 connected to the balloon body 4.3. The distal tube 4.1 is fixedly connected to the distal end of the inner tube 1, and the proximal tube 4.2 is fixedly connected to the distal end of the outer tube 2. The proximal tube 4.2 is welded to the outer tube 2, and the distal tube 4.1 is welded to the inner tube 1. The spinous ridge 5.4 is not fixedly connected to the proximal tube 4.2, the balloon body 4.3, or the distal tube 4.1. The tip tube 3 is welded to the front end of the inner tube 1. The inner tube 1 is located inside the outer tube 2. The proximal end of the spinous ridge 5.4 has a stepped portion 5.4.1, the distal end of the elastic band 5.5 is fixedly connected to the stepped portion 5.4.1, and the proximal end is fixedly connected to the proximal fixing sleeve 5.3. The elastic band 5.5 is flat. A first protrusion 5.5.1 is fixed to the surface of the elastic band 5.5 facing the outer tube 2. The first protrusion 5.5.1 has a first perforation. A first elastic rope 5.6 passing through the first perforation is connected between the proximal end of each ridge 5.4 and the proximal fixing sleeve 5.2. Two first protrusions 5.5.1 are fixed at each elastic band 5.5. A second protrusion 5.4.2 is fixed on both sides of the ridge 5.4. The second protrusion 5.4.2 has a second perforation. Three sets of elastic limiting units are connected between the distal sleeve 4.1 and the proximal fixing sleeve 5.3. Each set of elastic limiting units includes two second elastic ropes 5.7. The proximal end of the second elastic rope 5.7 is connected to the proximal fixing sleeve 5.3, and the distal end is connected to the distal sleeve 5.1. The second elastic rope 5.7 passes through the second perforation.

[0045] Compared to Embodiment 1, Embodiment 2 adds three sets of elastic limiting units to Embodiment 1, so that each spinous ridge has a second elastic cord on both sides. When the balloon is pushed to the designated position and during balloon inflation, the two second elastic cords on both sides of the spinous ridge will hold the spinous ridge only against the balloon surface, and make the surface of the spinous ridge that should be against the balloon surface tightly against the balloon surface. Thus, the cutting edge of the spinous ridge can face the plaque on the blood vessel wall, thereby preventing the spinous ridge from twisting during balloon inflation and causing the cutting edge to not face the blood vessel wall.

[0046] Although the present invention has been illustrated and described with reference to preferred embodiments, those skilled in the art should understand that various changes and modifications can be made to the present invention without departing from the scope defined by the claims.

Claims

1. A balloon catheter with a spinous process to prevent free movement, characterized in that, It includes an inner tube, a tip tube, an outer tube, a balloon unit, a proximal fixed cannula, a proximal movable cannula, a distal cannula, and three spinous ridges. The distal end of each spinous ridge is fixedly connected to the distal cannula, the proximal end of each spinous ridge is fixedly connected to the proximal movable cannula, the distal cannula is fixedly connected to the tip tube, the proximal movable cannula is passed through the outer tube and can move relative to the outer tube, and the proximal fixed cannula is fixedly connected to the outer tube. An elastic band connects the proximal end of each spinous ridge to the proximal fixed cannula.

2. The spike-process anti-freezing balloon catheter according to claim 1, characterized in that, The balloon unit includes a balloon body, a proximal tube connected to the balloon body, and a distal tube connected to the balloon body. The distal tube is fixedly connected to the distal end of the inner tube, and the proximal tube is fixedly connected to the distal end of the outer tube.

3. The spike-process anti-freezing balloon catheter according to claim 1, characterized in that, The proximal end of the spinous ridge has a stepped portion, the distal end of the elastic band is fixedly connected to the stepped portion, and the proximal end is fixedly connected to the proximal end fixing sleeve.

4. The spike-process anti-freezing balloon catheter according to claim 3, characterized in that, The elastic band is flat; a first protrusion is fixed to the surface of the elastic band facing the outer tube, the first protrusion has a first perforation, and a first elastic rope passing through the first perforation is connected between the proximal end of each ridge and the proximal end fixing sleeve.

5. The spike-process anti-freezing balloon catheter according to claim 4, characterized in that, Two of the first protrusions are fixed at each elastic band.

6. The spike-process anti-freezing balloon catheter according to claim 1, characterized in that, A second protrusion is fixed on both sides of the spinous ridge, and a second through hole is provided at the second protrusion. Three sets of elastic limiting units are connected between the distal sleeve and the proximal fixed sleeve. Each set of elastic limiting units includes two second elastic ropes. The proximal end of the second elastic rope is connected to the proximal fixed sleeve, and the distal end is connected to the distal sleeve. The second elastic rope passes through the second through hole.

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