Scoring instrument based on paper-cut structure

Abstract

The invention relates to the technical field of medical instruments, in particular to a nicking instrument based on a paper-cut structure, which comprises a destressing sleeve and a catheter seat, and further comprises a pushing section, a metal tube and a hollow head, the right end of the destressing sleeve is connected with the catheter seat, the pushing section is mounted at the left end of the destressing sleeve, and the other end of the pushing section is connected with the metal tube; the pushing section and the metal tube are coaxially connected, a PTA balloon penetrates through the catheter base, the stress relieving sleeve and the pushing section and enters the metal tube after penetrating through the pushing section, the PTA balloon is embedded in the metal tube, the tail end of the metal tube is connected with a bullet-shaped hollow head, when the PTA balloon is full, the surface of the cut metal tube begins to expand, and when the surface of the cut metal tube is expanded, the surface of the cut metal tube is expanded. When the surface of the metal tube expands to a certain degree, the expansion process of the metal tube cannot be continued due to the limitation of the included angle of the rhombus, at the moment, the continuous expansion force of the PTA balloon enables the node of the cutting section to drive the connecting rod to overturn together, and the overturned connecting rod can apply circumferential force to the narrow part of the blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a notching device based on a paper-kirigami structure. Background Art

[0002] Scored balloon is a medical device used in vascular interventional treatment, commonly used in vascular dilation and stent implantation of coronary arteries or peripheral arteries. Its design purpose is to help increase blood flow and reduce the risk of restenosis by dilating narrowed or diseased blood vessels.

[0003] At present, special balloons such as cutting balloons and scoring balloons are often used to expand the plaques for vascular calcification to achieve the therapeutic effect of vascular patency. The cutting balloon is to attach a microscopic blade to the balloon, and use the balloon expansion to promote the cutting effect of the blade on the plaque; the scoring balloon is to distribute the cutting pieces with a triangular cross-section on the surface of the balloon. When the balloon expands, the pressure is focused on the cutting pieces to treat the plaque. The above two special balloons can tear the plaque along the long axis of the blood vessel to avoid the risk of acute vascular occlusion such as dissection hematoma caused by uneven disordered expansion, but the guide wire or blade on the surface will cause the outer diameter of the balloon to become larger and the flexibility to decrease, thereby increasing the push resistance. The cutting balloon has 4 blades, and the scoring balloon generally has 3 cutting pieces. The cutting balloon blade and the cutting piece of the scoring balloon are generally less than 0.3mm in depth, and the cutting piece length is less than 100mm. It is difficult to cover the size of the lesion, and it needs to be expanded in steps and multiple times, resulting in the occurrence of vascular dissection. Cutting and scoring balloons are large in size, complex to operate, expensive, and require large amounts of inventory.

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

[0005] The technical purpose to be achieved by the present invention is: the present invention designs a notching instrument based on a paper-cut structure. When the balloon is inflated, the diameter of the metal tube increases, and the connecting rod is deformed and flipped to form vertically arranged notching parts. When the pressure is released, the metal tube will assist the balloon to re-embrace and return to a non-expanded state, thereby avoiding the problem of excessive outer diameter of the catheter in the non-expanded state. In addition, the number and size of the notching parts can be adjusted by designing the paper-cut structure to adapt to different lesion sizes, reduce the number of expansions, and save surgical time.

[0006] To achieve the above object, the present invention provides the following technical solutions: The invention provides a scoring device based on a paper-cut structure, comprising a stress relief sleeve and a catheter seat, and also comprising a push section, a metal tube and a hollow head. The right end of the stress relief sleeve is connected to the catheter seat, and the left end of the stress relief sleeve is installed with the push section. The surface of the push section is set to a smooth surface layer, and the other end of the push section is connected to the metal tube. The push section and the metal tube are coaxially connected. A PTA balloon passes through the catheter seat, the stress relief sleeve and the push section, and the PTA balloon passes through the push section and enters the metal tube. The PTA balloon is nested inside the metal tube. The push section is used to push the metal tube to the target blood vessel. A bullet-shaped hollow head is connected to the end of the metal tube. When the PTA balloon is filled, the surface of the cut metal tube begins to expand. When the surface of the metal tube expands to a certain extent, due to the limitation of the rhombus angle, the expansion process of the metal tube cannot continue. At this time, the force of the continued expansion of the PTA balloon causes the node of the cutting section to drive the connecting rod to flip together, and the flipped connecting rod can apply circumferential force to the stenosis of the blood vessel.

[0007] The metal tube has a smooth surface and can be made of an alloy with a shape memory effect. The metal tube is a tubular hollow structure, and is a hollow metal tube with a paper-cut structure cut from a nickel-titanium alloy tube.

[0008] The surface of the metal tube is cut with repeatedly arranged scoring units, and the scoring units are hollow thin-walled metal sheets. The hollow cutting patterns in the scoring units are diamond or rectangular, and the scoring 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 scoring units.

[0009] The connection point of the metal tube after being cut is set as a connecting rod, the shape formed between the connecting rods is a rhombus or a rectangle, and the intersection of the connecting rods is set as a node, and the flip angle of the node during the PTA balloon expansion process is 0-90°.

[0010] The metal tube is closely attached to the outer surface of the PTA balloon.

[0011] The PTA balloon expands the metal tube, and the diamond-shaped cutting seams on the surface of the metal tube expand circumferentially after cutting. When the PTA balloon is depressurized, the connecting rods and nodes on the surface of the metal tube flip 90° back to the initial position to assist the PTA balloon in hugging back.

[0012] The beneficial effects of the present invention are as follows: 1. The diamond-shaped cutting seams on the surface of the metal tube and its expansion characteristics enable the metal tube to continue to exert circumferential force on the narrowed part of the blood vessel by flipping the cut nodes after expansion to a certain extent, thereby effectively avoiding excessive expansion and reducing damage to the blood vessels, while ensuring the accuracy of the treatment effect.

[0013] 2. By adjusting the number and size of the scoring units, increasing the number of metal sheets that flip over after the ductile metal tube is expanded, and changing the flipping effect of the scoring units in the ductile section, the uniformity of lesion treatment can be improved.

[0014] 3. By controlling the expansion degree of the PTA balloon, the node angle and cutting depth can be precisely controlled. This makes the cutting depth more controllable, meeting the treatment requirements of different lesion depths, thereby improving the accuracy of treatment.

[0015] 4. The hollow metal tube with paper-cut structure provides fine cutting during the expansion process, ensuring uniform nodes of the metal tube during expansion and preventing over-expansion. Moreover, through the combination of paper-cut structure and shape memory alloy, the metal tube can adapt to the shape and size of the blood vessel at different expansion stages. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] The above and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 It is an overall schematic diagram of the present invention; Figure 2 This is a diagram of the metal tube of the present invention in a non-turned state; Figure 3 This is a diagram showing the metal tube in a flipping state of the present invention; Figure 4 is a cross-sectional view of the metal tube of the present invention without being turned over; Figure 5 It is a flip cross-sectional view of the metal tube of the present invention.

[0018] In the figure: 1, stress relief sleeve; 2, catheter seat; 3, push section; 4, metal tube; 41, notch unit; 42, connecting rod; 43, node; 5, hollow head. DETAILED DESCRIPTION The technical solutions in the embodiments of the present invention will be described below in conjunction with the drawings in the embodiments of the present invention. The embodiments described below are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0019] like Figure 1 ,2 , 3, 4 and 5, the invention provides a scoring device based on a paper-cut structure, comprising a stress relief sleeve 1 and a catheter seat 2, and also comprising a push section 3, a metal tube 4 and a hollow head 5, wherein the right end of the stress relief sleeve 1 is connected to the catheter seat 2, and the left end of the stress relief sleeve 1 is equipped with a push section 3, the surface of the push section 3 is set as a smooth surface layer, and the other end of the push section 3 is connected to the metal tube 4, and the push section 3 and the metal tube 4 are coaxially connected, and a PTA balloon is passed through between the catheter seat 2, the stress relief sleeve 1 and the push section 3, and the PTA balloon passes through the push section 3 and enters the metal tube 4. The metal tube 4 has a PTA balloon nested inside it, and 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 bullet-shaped hollow head 5. When the PTA balloon is filled, 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 diamond angle. At this time, the force of the continued expansion of the PTA balloon causes the node 43 of the cut section to drive the connecting rod 42 to flip together, and the flipped connecting rod 42 can apply a circumferential force to the stenosis of the blood vessel.

[0020] By utilizing the diamond-shaped cutting seam on the surface of the metal tube 4 and its expansion characteristics, after the metal tube 4 expands to a certain extent, the node 43 after cutting is turned over, and the circumferential force can continue to be applied to the stenosis of the blood vessel, thereby effectively avoiding excessive expansion, reducing damage to the blood vessel, and ensuring the accuracy of the treatment effect. By adjusting the number of cutting scoring units 41, the cutting effect can be adjusted, the uniformity of blood vessel expansion and cutting can be enhanced, and the lesion area can be treated more evenly, thereby improving the treatment effect, which is particularly suitable for different degrees of vascular stenosis and lesions. By adjusting the number and size of the scoring units 41, the scoring instrument can adapt to vascular 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, the angle of the node 43 and the cutting depth can be accurately controlled. This makes the cutting depth more controllable, meets the treatment requirements of different lesion depths, thereby improving the accuracy of the treatment. The push section 3 is coaxially connected to the metal, which is used to adapt to the overall exchange balloon. Balloons of different sizes can be replaced during the operation to treat the lesion, and the range of treatment diseases is wider.

[0021] like Figure 1 , 2 As shown in , 3 and 5, 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 is a tubular hollow structure, and the metal tube 4 is a hollow metal tube 4 with a paper-cut structure cut from a nickel-titanium alloy tube.

[0022] By using an alloy with a shape memory effect, the metal tube 4 can be restored to a predetermined shape under certain conditions. This allows the metal tube 4 to automatically retract to its original shape after expansion during use, thereby avoiding an excessively large outer diameter of the catheter, reducing pressure on the blood vessels during operation, and reducing the risk of vascular damage. The hollow metal tube 4 with a paper-cut structure provides fine cutting during the expansion process, ensuring that the nodes 43 of the metal tube 4 are uniform when expanded, and preventing over-expansion. Through the combination of the paper-cut structure and the shape memory alloy, the metal tube 4 can be adapted to the size of the PTA balloon expansion, so that the shape and size of the blood vessels can be adapted to different expansion stages. Due to the shape memory effect and the flexibility of the paper-cut structure, the metal tube 4 can adjust the treatment intensity according to the depth and size of the lesion, thereby ensuring accurate treatment of various types of vascular lesions. In addition, the smooth surface of the metal tube 4 helps to reduce friction in the blood vessels, reduce operating resistance, and improve the smoothness and efficiency of the operation.

[0023] like Figure 2 and 3 As shown, the surface of the metal tube 4 is cut with repeatedly arranged scoring units 41, and the scoring units 41 are hollow thin-walled metal sheets. The hollow cutting pattern in the scoring units 41 is a diamond or rectangle, and the scoring 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 scoring units 41.

[0024] The scoring unit 41 adopts a hollow structure, which can provide precise cutting and expansion effects. The diamond or rectangular cutting pattern can produce uniform force distribution during the expansion process, avoiding over-expansion or excessive local pressure, thereby effectively expanding the vascular lumen and reducing damage to the vascular wall. The arrangement and cutting design of the scoring unit 41 can accurately control the expansion depth of the metal tube 4, prevent over-expansion or tearing of the blood vessels, and thus improve the safety of the operation. The adjustable arrangement of the scoring unit 41 enables the device to accurately treat vascular lesions of different depths and morphologies, whether it is mild stenosis or severe blockage, and can provide targeted treatment plans. By adjusting the number and size of the scoring units 41, increasing the number of metal sheets that flip over after the expansion of the extensible metal tube 4, and changing the flipping effect of the scoring unit 41 of the extensible section, the uniformity of lesion treatment can be improved.

[0025] like Figure 2 , 3 As shown in , 4 and 5, the connection of the metal tube 4 after being cut is set as a connecting rod 42, the shape formed between the connecting rods 42 and the connecting rods 42 is a diamond or rectangle, and the intersection of the connecting rods 42 and the connecting rods 42 is set as a node 43, and the flipping angle of the node 43 during the PTA balloon expansion process is 0-90°.

[0026] When the balloon is filled, the diameter of the metal tube 4 increases, and the connecting rod 42 and the node 43 are deformed and flipped to form vertically arranged notches. When the pressure is removed, the metal tube 4 will assist the balloon to retract and return to the non-expanded state, thereby avoiding the problem of excessive outer diameter of the catheter in the non-expanded state. At the same time, by designing the shear shape of the notch unit 41, the number and size of the notch parts can be adjusted to adapt to the size of different lesions, reduce the number of expansions, and save surgical time. In addition, by controlling the degree of expansion, 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.

[0027] like Figure 1 , 4 As shown in Figures 5 and 5 , the metal tube 4 is closely attached to the outer surface of the PTA balloon.

[0028] The metal tube 4 is in close contact with the outer surface of the PTA balloon, ensuring that the metal tube 4 can expand evenly during expansion and coordinate with the expansion action of the balloon. This provides higher treatment accuracy, allowing the metal tube 4 to work together with the balloon during treatment, reducing possible errors or instabilities during treatment.

[0029] like Figure 1 , 2 As shown in Figures 3, 4 and 5, the PTA balloon expands the metal tube 4. After cutting, the diamond-shaped cutting seams on the surface of the metal tube 4 expand circumferentially. When the PTA balloon is depressurized, the connecting rods 42 and nodes 43 on the surface of the metal tube 4 flip 90° back to their initial positions to assist the PTA balloon in hugging back.

[0030] When the diamond-shaped cutting seams on the surface of the metal tube 4 expand circumferentially, it can effectively prevent the metal tube 4 from being over-expanded locally, thereby avoiding blood vessel rupture or other damage. Since the expansion is limited, the metal tube 4 can provide a moderate force to protect the blood vessels from excessive expansion, thereby reducing the risk of surgery. By carefully designing the shape and angle of the diamond-shaped cutting seams, the depth of the cutting can be accurately controlled. When the metal tube 4 expands, the opening degree of the cutting seams will also change, thereby changing the angle of the node 43, affecting the depth and effect of the treatment. This design makes the treatment process more refined and can meet the treatment requirements of different lesions.

[0031] During the working process of the present invention, the medical staff pushes the metal tube 4 to the target blood vessel by pushing the pushing section 3. At this time, the PTA balloon enters the metal tube 4 through the catheter seat 2. When the PTA balloon expands, the diamond-shaped cutting seam on the surface of the metal tube 4 will 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 cutting seam. At this time, the force of the balloon's continued expansion will drive the cutting section node 43 and its connecting rod 42 to flip, so that the angle of the diamond-shaped cutting seam is further opened, allowing the balloon to continue to expand until the rated pressure is reached.

[0032] When the balloon is depressurized, the connecting rod 42 and the node 43 will automatically flip back to the initial position and assist the balloon to retract, making it easier to remove, effectively applying a circumferential force at the stenosis of the blood vessel, and helping to improve the expansion effect.

[0033] While 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 variations may be made to the embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A scoring device based on a paper-kirigami structure, comprising a stress relief sleeve (1) and a catheter seat (2), characterized in that: The invention also comprises a push section (3), a metal tube (4) and a hollow head (5); the right end of the stress relief sleeve (1) is connected to a catheter seat (2); the left end of the stress relief sleeve (1) is installed with a push section (3); the surface of the push section (3) is provided 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 is passed through between the catheter seat (2), the stress relief sleeve (1) and the push section (3); the PTA balloon passes through the push section (3) and enters into the metal tube (4); the inner surface of the metal tube (4) is provided with a PTA balloon. 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 bullet-shaped hollow head (5), when the PTA balloon is filled, the surface of the cut metal tube (4) begins to expand, when the surface of the metal tube (4) expands to a certain extent, due to the limitation of the diamond angle, the expansion process of the metal tube (4) cannot continue, at this time, the force of the continued expansion of the PTA balloon causes the node (43) of the cut section to drive the connecting rod (42) to flip together, and the flipped connecting rod (42) can exert a circumferential force on the stenosis of the blood vessel.

2. A scoring device based on a paper-kirigami structure according to claim 1, characterized in that: The metal tube (4) has a smooth surface, and the metal tube (4) can be made of an alloy having a shape memory effect. The metal tube (4) is a tubular hollow structure, and the metal tube (4) is a hollow metal tube (4) with a paper-cut structure cut from a nickel-titanium alloy tube.

3. A scoring device based on a paper-kirigami structure according to claim 2, characterized in that: The surface of the metal tube (4) is cut with repeatedly arranged notched units (41), the notched units (41) are hollowed-out thin-walled metal sheets, the hollowed-out cutting patterns in the notched units (41) are rhombus or rectangular, and the notched units (41) can be arranged along the axial direction or at a certain angle to the axial direction, and the metal tube (4) is a paper-cut structure formed by cutting the notched units (41).

4. A scoring device based on a paper-kirigami structure according to claim 3, characterized in that: 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) and the connecting rods (42) is a rhombus or a rectangle, and the intersection of the connecting rods (42) and the connecting rods (42) is set as a node (43), and the node (43) has a flip angle of 0-90 degrees during the PTA balloon expansion process.

5. A scoring device based on a paper-kirigami structure according to claim 4, characterized in that: The metal tube (4) is in close contact with the outer surface of the PTA balloon.

6. A scoring device based on a paper-kirigami structure according to claim 5, characterized in that: The PTA balloon expands the metal tube (4), and after cutting, the diamond-shaped cutting seams on the surface of the metal tube (4) expand in the circumferential direction. When the PTA balloon is depressurized, the connecting rods (42) and nodes (43) on the surface of the metal tube (4) flip 90 degrees to return to the initial position, thereby assisting the PTA balloon to re-embrace.

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