A scoring device based on paper-cutting structure

Abstract

This invention relates to the field of medical device technology, specifically to a notching device based on a paper-cut structure, comprising a stress-relieving sleeve and a catheter hub, as well as a pusher section, a metal tube, and a hollow head. The right end of the stress-relieving sleeve is connected to the catheter hub, and the left end of the stress-relieving sleeve is fitted with the pusher section. The other end of the pusher section is connected to the metal tube, which is coaxially connected. A PTA balloon passes through the catheter hub, the stress-relieving sleeve, and the pusher section, and the PTA balloon passes through the pusher section into the metal tube. The PTA balloon is nested inside the metal tube, and the end of the metal tube is connected to a bullet-shaped hollow head. When the PTA balloon is inflated, the surface of the cut metal tube begins to expand. When the surface of the metal tube expands to a certain extent, the expansion process cannot continue due to the limitation of the rhomboid angle. At this time, the force of the continued expansion of the PTA balloon causes the node of the cut section to rotate together with the connecting rod. The rotated connecting rod can apply circumferential force to the narrowed part of the blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a scoring device based on a paper-cutting structure. Background Technology

[0002] A scoring balloon is a medical device used in interventional vascular procedures, commonly for the dilation and stenting of coronary or peripheral arteries. It is designed to help increase blood flow and reduce the risk of restenosis by dilating narrowed or diseased blood vessels.

[0003] Currently, for vascular calcification, specialized balloons such as cutting balloons and scoring balloons are commonly used to dilate the plaque and achieve vascular patency. Cutting balloons attach microblades to the balloon, and balloon expansion causes the blades to cut the plaque. Scoring balloons have triangular cutting elements distributed on the balloon surface; when the balloon expands, pressure is focused on these cutting elements to treat the plaque. Both types of specialized balloons can tear plaques along the long axis of the vessel, avoiding the risk of acute vascular occlusion such as dissection and hematoma caused by uneven and disordered expansion. However, the guidewires or blades on the surface increase the outer diameter of the balloon and reduce its flexibility, thus increasing the pushing resistance. Furthermore, cutting balloons typically have four blades, while scoring balloons generally have three. The cutting depth of both cutting balloon blades and scoring balloons is generally less than 0.3 mm, and the cutting length is less than 100 mm, making it difficult to cover the lesion size. This necessitates multiple dilation steps, potentially leading to vascular dissection. Cutting balloons and scoring balloons are large in size, complex to operate, costly, and require a large inventory.

[0004] In view of the above, in order to overcome the above technical problems, the present invention designs a scoring device based on a paper-cutting structure, which solves the above technical problems. Summary of the Invention

[0005] The technical objective of this invention is as follows: By designing a scoring device based on a paper-cut structure, when the balloon is inflated, the diameter of the metal tube increases, and the connecting rod deforms and flips to form vertically arranged scoring elements. When the pressure is released, the metal tube assists the balloon to retract and return to the non-dilated state, avoiding the problem of excessive outer diameter of the catheter in the non-dilated state. Furthermore, the number and size of the scoring elements can be adjusted by designing the paper-cut structure to adapt to different lesion sizes, reduce the number of dilation operations, and save surgical time.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] The invention provides a notching device based on a paper-cut structure, including a stress-relieving sleeve and a catheter hub, as well as a pusher section, a metal tube, and a hollow head. The right end of the stress-relieving sleeve is connected to the catheter hub, and the left end of the stress-relieving sleeve is equipped with the pusher section. The surface of the pusher section is set with a smooth surface layer, and the other end of the pusher section is connected to the metal tube. The pusher section and the metal tube are coaxially connected. A PTA balloon passes through the catheter hub, the stress-relieving sleeve, and the pusher section, and the PTA balloon passes through the pusher section and enters the metal tube. The PTA balloon is nested inside the metal tube. The pusher section is used to push the metal tube to the target blood vessel. The end of the metal tube is connected to a bullet-shaped hollow head. When the PTA balloon is inflated, the surface of the cut metal tube begins to expand. When the surface of the metal tube expands to a certain extent, the expansion process of the metal tube cannot continue due to the limitation of the rhomboid angle. At this time, the force of the continued expansion of the PTA balloon causes the node of the cutting section to rotate together with the connecting rod. The rotated connecting rod can apply circumferential force to the narrowed part of the blood vessel.

[0008] The surface of the metal tube is smooth. The metal tube may be made of an alloy with shape memory effect. The metal tube has a tubular hollow structure and is a paper-cut hollow metal tube cut from a nickel-titanium alloy tube.

[0009] The surface of the metal tube is cut with repeating etched units, which are hollow thin-walled metal sheets. The hollow cutting patterns in the etched units are rhomboid or rectangular, and the etched units can be arranged along the axial direction or at a certain angle to the axial direction. The metal tube is a paper-cut structure formed by cutting the etched units.

[0010] The joint where the metal tube is cut is designated as a connecting rod. The shape formed between the connecting rods is rhomboid or rectangular, and the intersection of the connecting rods is designated as a node. The node rotates at an angle of 0-90° during the expansion of the PTA balloon.

[0011] The metal tube is attached tightly to the outer surface of the PTA balloon.

[0012] The PTA balloon inflates the metal tube, and the diamond-shaped cuts on the surface of the metal tube after cutting expand circumferentially. When the PTA balloon depressurizes, the connecting rods and nodes on the surface of the metal tube rotate 90° back to their initial positions, assisting the PTA balloon in repositioning.

[0013] The beneficial effects of this invention are as follows:

[0014] 1. The diamond-shaped cut slits on the surface of the metal tube and their expansion characteristics allow the metal tube to expand to a certain extent. By flipping the cut nodes, circumferential force can continue to be applied to the narrowed part of the blood vessel, thereby effectively avoiding over-expansion, reducing damage to the blood vessel, and ensuring the precision of the treatment effect.

[0015] 2. By adjusting the number and size of the scoring units, increasing the number of metal sheets that flip after the expansion of the extendable metal tube, and changing the flipping effect of the scoring units in the extendable segment, the uniformity of lesion treatment can be improved.

[0016] 3. By controlling the inflation degree of the PTA balloon, precise control over the node angle and cutting depth can be achieved. This makes the cutting depth more controllable, meeting the treatment needs of different lesion depths, thereby improving the accuracy of treatment.

[0017] 4. The paper-cut structure of the hollowed-out metal tube provides precise cutting during the expansion process, ensuring uniform nodes during expansion and preventing over-expansion. Furthermore, through the combination of the paper-cut structure and shape memory alloy, the metal tube can adapt to the shape and size of the blood vessels at different expansion stages. Attached Figure Description

[0018] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0019] The above and other aspects of the invention will now be described by way of example only, with reference to the accompanying drawings, in which:

[0020] Figure 1 This is an overall schematic diagram of the invention;

[0021] Figure 2 This is a diagram of the metal tube of the present invention in its unflipped state;

[0022] Figure 3 This is a diagram showing the flipped state of the metal tube of the present invention;

[0023] Figure 4 This is a cross-sectional view of the metal tube of the present invention before it is flipped over;

[0024] Figure 5 This is a cross-sectional view of the metal tube of the present invention when flipped.

[0025] In the figure: 1. Stress-relieving sleeve; 2. Guide tube seat; 3. Push section; 4. Metal tube; 41. Scoring unit; 42. Connecting rod; 43. Node; 5. Hollow head. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be described below with reference to the accompanying drawings. The embodiments described below are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] like Figure 1 , 2 As shown in Figures 3, 4, and 5, the invention provides a scoring device based on a paper-cutting structure, including a stress-relieving sleeve 1 and a catheter seat 2, as well as a pusher section 3, a metal tube 4, and a hollow head 5. The right end of the stress-relieving sleeve 1 is connected to the catheter seat 2, and the left end of the stress-relieving sleeve 1 is fitted with the pusher section 3. The surface of the pusher section 3 is made into a smooth surface layer, and the other end of the pusher section 3 is connected to the metal tube 4. The pusher section 3 and the metal tube 4 are coaxially connected. A PTA balloon passes through the catheter seat 2, the stress-relieving sleeve 1, and the pusher section 3, and the PTA balloon passes through the pusher section 3 and enters the metal tube 4. Within the tube 4, a PTA balloon is nested inside the metal tube 4. The pusher section 3 is used to push the metal tube 4 to the target blood vessel. The end of the metal tube 4 is connected to a bullet-shaped hollow head 5. When the PTA balloon is inflated, the surface of the cut metal tube 4 begins to expand. When the surface of the metal tube 4 expands to a certain extent, the expansion process of the metal tube 4 cannot continue due to the limitation of the rhomboid angle. At this time, the force of the PTA balloon continuing to expand causes the node 43 of the cut section to rotate together with the connecting rod 42. The rotated connecting rod 42 can apply circumferential force to the narrowed part of the blood vessel.

[0028] Utilizing the rhomboid slits on the surface of the metal tube 4 and its expansion characteristics, after the metal tube 4 expands to a certain extent, the cut node 43 is flipped to continue applying circumferential force to the narrowed area of ​​the blood vessel, effectively avoiding over-expansion, reducing damage to the blood vessel, and ensuring the precision of the treatment effect. By adjusting the number of cutting notch units 41, the cutting effect can be adjusted, enhancing the uniformity of blood vessel expansion and cutting, and treating the lesion area more evenly, thereby improving the treatment effect, especially suitable for blood vessel stenosis and lesions of different degrees. By adjusting the number and size of the notch units 41, the notch instrument can adapt to blood vessel lesions of different sizes and shapes, and can be flexibly adjusted according to the specific condition of the patient. At the same time, by controlling the expansion degree of the PTA balloon, precise control of the angle of node 43 and the cutting depth can be achieved. This makes the cutting depth more controllable, meeting the treatment needs of different lesion depths, thereby improving the precision of the treatment. The push segment 3 is coaxially connected to the metal, which is used to adapt to the integral exchangeable balloon. Different sized balloons can be replaced during the operation to treat the lesion, thus expanding the range of diseases that can be treated.

[0029] like Figure 1 , 2As shown in Figures 3 and 5, the surface of the metal tube 4 is smooth. The metal tube 4 may be made of an alloy with shape memory effect. The metal tube 4 has a tubular hollow structure and is a paper-cut hollow metal tube 4 cut from a nickel-titanium alloy tube.

[0030] Using an alloy with shape memory effect, the metal tube 4 can recover to a predetermined shape under specific conditions. This allows the metal tube 4 to automatically retract to its original shape after expansion during use, thereby avoiding excessive catheter diameter, reducing pressure on the blood vessel during operation, and lowering the risk of vascular injury. The paper-cut structure of the perforated metal tube 4 provides precise cutting during expansion, ensuring uniformity of the nodes 43 during expansion and preventing over-expansion. The combination of the paper-cut structure and the shape memory alloy allows the metal tube 4 to be adapted to the size of the PTA balloon expansion, thus adapting to the shape and size of the blood vessel at different expansion stages. Due to the flexibility of the shape memory effect and the paper-cut structure, the metal tube 4 can adjust the treatment intensity according to the depth and size of the lesion, thereby ensuring precise treatment of various types of vascular lesions. In addition, the smooth surface of the metal tube 4 helps reduce intravascular friction, lowers operational resistance, and improves the smoothness and efficiency of the operation.

[0031] like Figure 2 and 3 As shown, the surface of the metal tube 4 is cut with repeating etched units 41. The etched unit 41 is a hollow thin-walled metal sheet. The hollow cutting pattern in the etched unit 41 is rhomboid or rectangular. The etched units 41 can be arranged along the axial direction or at a certain angle to the axial direction. The metal tube 4 is a paper-cut structure formed by cutting the etched units 41.

[0032] The scoring unit 41 employs a hollow structure, providing precise cutting and expansion effects. The rhomboid or rectangular cutting pattern generates a uniform force distribution during expansion, avoiding over-expansion or excessive local pressure, thereby effectively enlarging the vascular lumen and reducing damage to the vessel wall. The arrangement and cutting design of the scoring unit 41 precisely controls the expansion depth of the metal tube 4, preventing over-expansion or tearing of the vessel, thus improving surgical safety. The adjustable arrangement of the scoring unit 41 allows the device to precisely treat vascular lesions of different depths and shapes, providing targeted treatment plans for both mild stenosis and severe blockage. By adjusting the number and size of the scoring unit 41, increasing the number of metal plates that flip after expansion of the extendable metal tube 4, and altering the flipping effect of the extendable scoring unit 41, the uniformity of lesion treatment can be improved.

[0033] like Figure 2 , 3As shown in Figures 4 and 5, the connection point of the metal tube 4 after being cut is set as a connecting rod 42. The shape formed between the connecting rods 42 is a rhombus or a rectangle, and the junction of the connecting rods 42 is set as a node 43. The node 43 flips at an angle of 0-90° during the expansion of the PTA balloon.

[0034] When the balloon inflates, the diameter of the metal tube 4 increases, and the connecting rod 42 and node 43 deform and flip, forming vertically arranged notches. When the pressure is released, the metal tube 4 assists the balloon to retract and return to its non-inflated state, thus avoiding the problem of an excessively large catheter outer diameter in the non-inflated state. Simultaneously, the number and size of the notching elements can be adjusted by designing the shear shape of the notching unit 41 to accommodate different lesion sizes, reducing the number of inflating procedures and saving surgical time. Furthermore, by controlling the degree of inflation, the angle of the node 43 can be adjusted, thereby achieving precise control of the cutting depth to meet the treatment needs of different lesions.

[0035] like Figure 1 , 4 As shown in Figures 5 and 6, the metal tube 4 is tightly attached to the outer surface of the PTA balloon.

[0036] The metal tube 4 is tightly attached to the outer surface of the PTA balloon, ensuring that it expands uniformly during inflation and coordinates with the balloon's expansion. This provides higher treatment precision, allowing the metal tube 4 to work in conjunction with the balloon during treatment and reducing potential errors or instabilities.

[0037] like Figure 1 , 2 As shown in Figures 3, 4, and 5, the PTA balloon inflates the metal tube 4. After cutting, the diamond-shaped cut slits on the surface of the metal tube 4 expand circumferentially. When the PTA balloon depressurizes, the connecting rod 42 and node 43 on the surface of the metal tube 4 rotate 90° back to their initial positions, assisting the PTA balloon in repositioning.

[0038] When the diamond-shaped sutures on the surface of the metal tube 4 expand circumferentially, they effectively prevent excessive local expansion of the metal tube 4, thereby avoiding vascular rupture or other damage. Because expansion is restricted, the metal tube 4 can provide appropriate force, protecting the blood vessel from excessive expansion and reducing surgical risks. By carefully designing the shape and angle of the diamond-shaped sutures, the cutting depth can be precisely controlled. As the metal tube 4 expands, the opening degree of the sutures changes accordingly, thus altering the angle of node 43 and affecting the depth and effectiveness of treatment. This design makes the treatment process more precise and can meet the treatment needs of different lesions.

[0039] During operation, medical personnel push the pusher section 3 to advance the metal tube 4 to the target blood vessel. At this time, the PTA balloon enters the metal tube 4 through the catheter hub 2. When the PTA balloon inflates, the diamond-shaped slits on the surface of the metal tube 4 expand circumferentially. When the metal tube 4 expands to a certain extent, the balloon cannot continue to expand due to the limitation of the angle of the diamond-shaped slits. At this point, the force of the balloon's continued expansion causes the cutting section node 43 and its connecting rod 42 to flip, thereby further opening the angle of the diamond-shaped slits, allowing the balloon to continue expanding until the rated pressure is reached.

[0040] When the balloon is depressurized, the connecting rod 42 and the node 43 automatically flip back to their initial positions and assist the balloon in retraction, making it easy to remove. This effectively applies circumferential force to the narrowed area of ​​the blood vessel, helping to improve the dilation effect.

[0041] Embodiments of the present invention have been shown and described. It will be apparent to those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A scoring device based on a paper-cutting structure, comprising a stress-relieving sleeve (1) and a guide tube seat (2), characterized in that, It also includes a push section (3), a metal tube (4), and a hollow head (5). The right end of the stress-relieving sleeve (1) is connected to a catheter seat (2), and the left end of the stress-relieving sleeve (1) is equipped with a push section (3). The surface of the push section (3) is set as a smooth surface layer. The other end of the push section (3) is connected to a metal tube (4). The push section (3) and the metal tube (4) are coaxially connected. A PTA balloon passes through the catheter seat (2), the stress-relieving sleeve (1), and the push section (3), and the PTA balloon passes through the push section (3) and enters the metal tube (4). The inner surface of the metal tube (4) is... The PTA balloon is nested in the middle. The pushing section (3) is used to push the metal tube (4) to the target blood vessel. The end of the metal tube (4) is connected to a hollow head (5) in the shape of a bullet. When the PTA balloon is inflated, the surface of the cut metal tube (4) begins to expand. When the surface of the metal tube (4) expands to a certain extent, the expansion process of the metal tube (4) cannot continue due to the limitation of the rhomboid angle. At this time, the force of the PTA balloon continuing to expand causes the node (43) of the cutting section to drive the connecting rod (42) to flip together. The flipped connecting rod (42) can apply circumferential force to the narrow part of the blood vessel. The surface of the metal tube (4) is smooth. The metal tube (4) can be made of an alloy with shape memory effect. The metal tube (4) has a tubular hollow structure and is a paper-cut hollow metal tube (4) cut from a nickel-titanium alloy tube. The surface of the metal tube (4) is cut with repeating etched units (41). The etched units (41) are hollow thin-walled metal sheets. The hollow cutting patterns in the etched units (41) are rhombuses or rectangles. The etched units (41) can be arranged along the axial direction or at a certain angle to the axial direction. The metal tube (4) is a paper-cut structure formed by cutting the etched units (41). The metal tube (4) is cut and the connection is set as a connecting rod (42). The shape formed between the connecting rod (42) and the connecting rod (42) is rhomboid or rectangular. The junction of the connecting rod (42) and the connecting rod (42) is set as a node (43). The node (43) flips at an angle of 0-90° during the expansion of the PTA balloon. The metal tube (4) is tightly attached to the outer surface of the PTA balloon; The PTA balloon inflates the metal tube (4), and the diamond-shaped cut slits on the surface of the metal tube (4) after cutting expand circumferentially. When the PTA balloon depressurizes, the connecting rod (42) and node (43) on the surface of the metal tube (4) rotate 90° back to their initial positions to assist the PTA balloon in repositioning.

Images