Nicking balloon catheter

Abstract

The utility model discloses a nicked balloon catheter which comprises a balloon, a catheter body, a catheter body and a catheter body. The catheter is used for pushing the balloon; the net rack is arranged outside the balloon, the net rack comprises a plurality of nicking rods distributed in the circumferential direction of the balloon and connecting wires arranged between every two adjacent nicking rods, the two ends of each connecting wire are connected with the corresponding two adjacent nicking rods respectively, the nicking rods are arranged on the same nicking rod, and the nicking rods are connected with the connecting wires respectively. Every two adjacent connecting wires are arranged on the left side and the right side of the same nicking rod respectively, the nicking balloon catheter has a contraction state and an expansion state, when the nicking balloon catheter is in the contraction state, the balloon contracts, the nicking rods extend in the length direction of the balloon, and when the nicking balloon catheter is in the expansion state, the nicking rods extend in the length direction of the balloon. The radial distance of the net rack is larger than that of the balloon, the balloon expands, and the net rack protrudes out of the surface of the balloon.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, and particularly relates to a notched balloon catheter. Background Art

[0002] Peripheral Artery Disease (PAD) in the human body is a common disease, which generally refers to various peripheral artery lesions except for coronary arteries and intracranial arteries. One of the main current methods for treating PAD is angioplasty, and the instrument used is a balloon dilatation catheter. Through the balloon dilatation catheter, angioplasty is implemented to shape the blood vessel passage, or when a stent needs to be placed in the blood vessel to ensure blood vessel patency, the balloon catheter is used for pre-dilatation or re-dilatation, etc.

[0003] Existing cutting balloons or notched balloons are formed by inlaying or bonding cutting blades or notching components with notching ability on the surface of a common-structured balloon. During the process of angioplasty, cutting balloons or notched balloons are usually used for dilating the diseased part of the blood vessel. Such devices can produce a plurality of straight and / or curved indentations or incisions on the surface of the diseased part. When the balloon further dilates the lesion in the blood vessel, these indentations or incisions serve as the concentration points of the dilatation force on the circumferential tissue of the lesion. Compared with the effect of ordinary balloon angioplasty, the diseased position can be dilated with a smaller dilatation pressure, and at the same time, because of the cutting or notching ability, the dilatation becomes easier, a larger lumen size is obtained, the rebound is reduced, and the damage to the blood vessel wall is also reduced. In addition, if there is further placement of a therapeutic drug at the diseased position, the drug will be more easily infiltrated into the notches or incisions on the vascular intima and gradually diffuse into the tissues of the deep blood vessel wall. Therefore, such balloon dilatation catheter devices have good lumen dilatation effects during the treatment of lesions.

[0004] Existing structures with similar longitudinal blades firmly adhered to the balloon are generally considered to be the most effective structures for cutting plaques or fibers, but such structures are not flexible enough, usually cannot reach and treat very tortuous lesions, and the balloon diameters of products with such structures are small and the lengths are short.

[0005] Existing spiral notching wire structures surrounding the balloon periphery produce spiral notching grooves at the lesion during dilation, but in the actual implementation process, as the notched balloon dilates, the spiral structure may be more likely to become uncontrollable and has poor elastic recovery.

[0006] Existing multi-wire notched balloons arrange one or more straight wires along the longitudinal direction of the balloon in the circumferential direction evenly, so that longitudinal notching grooves can be produced. However, when the number of wires in such a structure is greater than 3, wire entanglement is likely to occur, thus also limiting the number of notches.

[0007] Therefore, in the existing technology, the notched balloon catheter either has poor structural stability or has problems restricting balloon expansion, resulting in an unsatisfactory notching effect, which in turn affects the treatment effect. Summary of the Invention

[0008] The purpose of the present utility model is to overcome the defects in the existing technology and provide a novel notched balloon catheter.

[0009] To achieve the above object, the technical solution adopted by the present utility model is:

[0010] A notched balloon catheter, comprising:

[0011] A balloon, which can be relatively contracted and expanded;

[0012] A catheter for pushing the balloon;

[0013] A wire frame disposed outside the balloon. The wire frame includes a plurality of notched rods distributed along the circumferential direction of the balloon and connecting wires disposed between two adjacent notched rods. Both ends of each connecting wire are respectively connected to two adjacent notched rods. On the same notched rod, two adjacent connecting wires are respectively disposed on the left and right sides of the same notched rod. The notched balloon catheter has a contracted state and an expanded state. When in the contracted state, the balloon contracts, and the notched rods extend along the length direction of the balloon. When in the expanded state, the radial distance of the wire frame is greater than the radial distance of the balloon, the balloon expands, and the wire frame protrudes from the surface of the balloon.

[0014] In some embodiments, when in the contracted state, the included angle between the notched rod and the axial direction of the balloon is 0 to 45°.

[0015] In some embodiments, when in the contracted state, the notched rod is one of a straight line, a wavy line, a straight line with an arc, and a broken line.

[0016] In some embodiments, when the notched rod is one of a wavy line, a straight line with an arc, and a broken line, when converting from the contracted state to the expanded state, the notched rod undergoes tensile deformation.

[0017] In some embodiments, when in the contracted state, the connecting wire is one of an S shape, a Z shape, and an irregular wavy shape.

[0018] In some embodiments, when converting from the contracted state to the expanded state, the connecting wire undergoes tensile deformation.

[0019] In some embodiments, the scoring rod includes a main body portion, a proximal end portion and a distal end portion respectively disposed at two ends of the main body portion, and the main body portion is connected to the connecting wire.

[0020] In some embodiments, when in the contracted state, the proximal end portion and / or the distal end portion have an S-shaped bend.

[0021] In some embodiments, the distal end portion and / or the proximal end portion are fixedly connected to the balloon by welding or bonding.

[0022] In some embodiments, when in the expanded state, the scoring rod spirally surrounds the outside of the balloon.

[0023] In some embodiments, the mesh frame is made of a flexible material, and the thickness of the scoring rod and / or the connecting wire is 0.1-0.5 mm.

[0024] In some embodiments, when in the expanded state, two adjacent scoring rods and two adjacent connecting wires located between the two adjacent scoring rods enclose a quadrilateral.

[0025] In some embodiments, in the enclosed quadrilateral, the lengths of two adjacent scoring rods are equal, and the lengths of two adjacent connecting wires are equal.

[0026] In some embodiments, the catheter includes a catheter seat disposed at the proximal end of the catheter, an outer tube disposed outside the balloon, and an inner tube disposed inside the balloon. The catheter has a first cavity and a second cavity. The first cavity is used for threading a guide wire, and the second cavity is used for perfusing liquid or gas.

[0027] Due to the application of the above technical solutions, the present utility model has the following advantages compared with the prior art:

[0028] 1. In this solution, the connecting wires of the mesh frame are connected in a staggered manner, so that the whole mesh frame has a better elastic deformation space, and the risk of the connecting wire breaking caused by the scoring structure embedding into the blood vessel when the balloon expands is reduced;

[0029] 2. In this solution, the scoring rod can generate different tensile deformations according to the expansion size of the balloon. Since the overall design size is larger than the balloon size in the radial direction, the mesh frame can always be in a convex state on the surface of the balloon. In this way, when in use, both the scoring rod and the connecting wire of the mesh frame can play a scoring role;

[0030] 3. In this solution, the connecting wires of the scoring mesh frame device can adjust the density and the connecting wires of the connecting wires according to the length and the diameter of the balloon. Therefore, to a certain extent, it can ensure that the rollback property of the balloon is improved, and it does not affect the expansion of the balloon when the balloon expands. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 Schematic diagram of the flattened and unfolded state of the scored balloon catheter in a contracted state in an embodiment of the present utility model;

[0032] Figure 2 Three-dimensional schematic diagram of the scored balloon catheter in a contracted state in an embodiment of the present utility model;

[0033] Figure 3 Three-dimensional schematic diagram of the scored balloon catheter in an inflated state in an embodiment of the present utility model;

[0034] The reference numerals in the figure are:

[0035] 1 - balloon; 2 - catheter; 21 - catheter hub; 22 - outer tube; 23 - inner tube; 24 - first lumen; 25 - second lumen; 3 - wire frame; 31 - scored rod; 311 - main body portion; 312 - proximal end portion; 313 - distal end portion; 32 - connecting wire; 4 - radiopaque ring. Detailed implementation manners

[0036] The technical solution of the present utility model will be further described below in conjunction with the accompanying drawings and specific embodiments.

[0037] In the description of the present utility model, directions such as "left", "right", "proximal end portion", "distal end portion", etc. are all defined with reference to the directions observed when the user uses the scored balloon catheter of the present utility model. The end closer to the user's hand operating the instrument is the "proximal end portion", and the farther end is the "distal end portion". That is, as Figure 2 shown, the upper side direction in the figure is the "distal end portion", the lower side direction in the figure is the "proximal end portion", the left side direction in the figure is "left", and the right side direction in the figure is "right". The definition of the above directions is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present utility model.

[0038] This embodiment provides a scored balloon catheter. Referring to Figures 1-3 shown, in some embodiments, the scored balloon catheter includes a balloon 1, a catheter 2 and a wire frame 3. The scored balloon catheter has an inflated state and a contracted state. The balloon 1 can be relatively contracted and inflated. The catheter 2 is used to push the balloon 1. Gas or liquid is introduced into the balloon 1 through the catheter 2 to inflate the balloon 1. Specifically, the catheter 2 includes a catheter hub 21 provided at the proximal end of the catheter, an outer tube 22 provided outside the balloon 1, and an inner tube 23 provided inside the balloon 1. The catheter hub 21 is specifically provided in a Y shape. The catheter 2 has a first lumen 24 and a second lumen 25. The first lumen 24 is used for threading a guide wire, and the second lumen 25 is used for perfusing liquid or gas after being connected to a pressurizing device.

[0039] The notched balloon catheter may further include a radiopaque ring 4, which is disposed at both ends of the balloon 2 in the longitudinal direction (axial direction) for marking the position of the notched balloon catheter under X-ray.

[0040] The wire frame 4 is disposed outside the balloon 2 and expands with the expansion of the balloon 2 and contracts with the contraction of the balloon 3. The wire frame 4 includes a plurality of notched rods 31 distributed along the circumferential direction of the balloon 2 and connecting wires 32 disposed between two adjacent notched rods 31. The number of notched rods 31 may be 3 to 8, preferably 6. Both ends of the connecting wire 32 are respectively connected to two adjacent notched rods 31. On the same notched rod 31, two adjacent connecting wires 32 are respectively disposed on the left and right sides of the same notched rod 31, that is, on the same notched rod 31, two adjacent connecting wires 32 are connected in a staggered manner. On the same notched rod 31, the adjacent connection points thereof connected to the connecting wire 32 are not in the same radial direction, and are in an interleaved connection structure.

[0041] The notched rod 31 includes a main body portion 311, a proximal end portion 312 and a distal end portion 313 respectively disposed at both ends of the main body portion 311. The main body portion 311 is connected to the connecting wire 32, and the distal end portion 313 and / or the proximal end portion 312 are fixedly connected to the balloon 1 by welding or bonding. When the notched balloon catheter is in a contracted state, the notched rod 31 may be set as one of a straight line, a wavy line, a straight line with an arc, and a broken line. When the notched rod 31 is one of a wavy line, a straight line with an arc, and a broken line, when converting from the contracted state to the expanded state, the notched rod 31 will be stretched and deformed, so that the wire frame 3 can expand synchronously with the balloon 1; when the notched balloon catheter is in a contracted state, the connecting wire may also be set as one of an S shape, a Z shape, and an irregular wavy shape. When converting from the contracted state to the expanded state, the connecting wire 32 will be stretched and deformed, so that the wire frame 3 can expand synchronously with the balloon 1; when the notched balloon catheter is in a contracted state, the proximal end portion 312 and / or the distal end portion 313 may be set to have an S-shaped bend. Then, when the balloon 1 expands, the S-shaped bend is stretched and deformed, so that the wire frame 3 can expand synchronously with the balloon 1.

[0042] The thickness of the notched rod 31 and / or the connecting wire 32 in the wire frame 3 is 0.1 - 0.5 mm. Compared with the wire frame 3 with a thickness less than 0.1 mm, by setting the notched rod 31 and / or the connecting wire 32 with a certain thickness, the notching and cutting effect of the wire frame 3 on blood vessels is stronger. The wire frame 3 is made of a flexible material. In some embodiments, the wire frame may be processed from a metal tube, and the metal material may be a nickel-titanium alloy.

[0043] Such as Figures 1-2As shown, when the scored balloon catheter is in a contracted state, the balloon 1 contracts, and the scored rod 31 extends along the length direction of the balloon 1. The angle between the scored rod 31 and the axial direction of the balloon 1 is 0-45°, preferably 5°. By setting the scored rod 31 to be inclined relative to the axial direction of the balloon 1, when the balloon 1 is expanded, the scored rod 31 can be spirally wrapped around the balloon 1, so that the structure of the mesh frame 3 is more stable, the fitting effect on the balloon 1 is better, and the cutting effect on the blood vessel is also better. Figure 3 As shown, when the scored balloon catheter is in an expanded state, the radial distance of the mesh 3 is greater than the radial distance of the balloon 3, the balloon 1 expands, the mesh 3 protrudes from the surface of the balloon 1, the scored rods 31 spirally surround the outside of the balloon 1, and the two adjacent scored rods 31 and the two adjacent connecting wires 32 located between the two adjacent scored rods 31 are arranged to form a quadrilateral. In some embodiments, in the quadrilateral formed by the arrangement, the lengths of the two adjacent scored rods 31 are equal, and the lengths of the two adjacent connecting wires 32 are equal. This arrangement allows the mesh 3 to cut the blood vessel more evenly, and the mesh 3 is also more flexible as the balloon 1 is deployed.

[0044] In the utility model, the density of the connecting wires 32 in the mesh frame can be adjusted according to the length and diameter of the balloon 1, thereby ensuring the contraction and expansion of the balloon 1, and the expansion of the balloon will not be affected by the limitation of the mesh frame 3.

[0045] The following describes the method for operating the scored balloon catheter of the utility model by the user:

[0046] 1. The guide wire is inserted into the blood vessel.

[0047] 2. The guide wire is inserted into the first lumen of the catheter, and the notched balloon catheter is inserted into the blood vessel along the guide wire to the location of the vascular lesion.

[0048] 3. The second lumen of the catheter is connected to a charging device to inject liquid or gas.

[0049] 4. The balloon expands, and the mesh expands accordingly. The scoring wires and connecting wires score the lesion site to cut open the stubborn plaque and complete the vascular dilation.

[0050] 5. Use the inflation device to slowly withdraw the liquid or gas, evacuate the balloon, deflate the balloon, retract the stent, and remove the stent.

[0051] After the balloon 1 is pressurized, the connecting wire 32 will be straightened and deformed due to the misaligned distribution of the notched rods 31. Since the initially designed mesh frame 31 is larger than the size of the matching balloon 1 after expansion, the mesh frame 3 will always be on the surface of the balloon 1 after the balloon 1 is expanded, that is, the expansion of the balloon 1 will not be restricted, and the mesh frame 3 will always protrude from the surface of the balloon 1. After the balloon 1 is depressurized, the mesh frame 3 will retract with the balloon 1 and break away from the contact with the blood vessel wall, and then the balloon 1 can be withdrawn from the body along with the guide wire.

[0052] The above embodiments are only used to illustrate the technical concept and features of the present utility model. The purpose is to enable those skilled in the art to understand the content of the present utility model and implement it accordingly, and it should not be used to limit the protection scope of the present utility model. Any equivalent changes or modifications made according to the spirit and essence of the present utility model should be covered within the protection scope of the present utility model.

Claims

1. A notched balloon catheter, characterized in that, Comprising: A balloon that can be relatively contracted and expanded; A catheter for pushing the balloon; A wire frame disposed outside the balloon. The wire frame includes a plurality of scored rods distributed along the circumferential direction of the balloon and connecting wires disposed between two adjacent scored rods. Both ends of each connecting wire are respectively connected to two adjacent scored rods. On the same scored rod, two adjacent connecting wires are respectively disposed on the left and right sides of the same scored rod. The scored balloon catheter has a contracted state and an expanded state. When in the contracted state, the balloon contracts, and the scored rods extend along the length direction of the balloon. When in the expanded state, the radial distance of the wire frame is greater than the radial distance of the balloon, the balloon expands, and the wire frame protrudes from the surface of the balloon.

2. The notched balloon catheter according to claim 1, wherein: When in the contracted state, the included angle between the scored rods and the axial direction of the balloon is 0 to 45°.

3. The notched balloon catheter according to claim 1, wherein: When in the contracted state, the scored rods are one of a straight line, a wavy line, a straight line with an arc, and a broken line.

4. The notched balloon catheter according to claim 3, characterized in that: When the scored rods are one of a wavy line, a straight line with an arc, and a broken line, when converting from the contracted state to the expanded state, the scored rods undergo tensile deformation.

5. The notched balloon catheter according to claim 1, wherein: When in the contracted state, the connecting wires are one of an S shape, a Z shape, and an irregular wavy shape.

6. The notched balloon catheter according to claim 3, wherein: When converting from the contracted state to the expanded state, the connecting wires undergo tensile deformation.

7. The notched balloon catheter according to claim 1, wherein: The scored rods include a main body portion, a proximal end portion, and a distal end portion respectively disposed at both ends of the main body portion. The main body portion is connected to the connecting wires.

8. The notched balloon catheter according to claim 7, wherein: When in the contracted state, the proximal end portion and / or the distal end portion have an S-shaped bend.

9. The notched balloon catheter according to claim 7, wherein: The distal end portion and / or the proximal end portion are fixedly connected to the balloon by welding or bonding.

10. The notched balloon catheter according to any one of claims 1-9, characterized in that: When in the expanded state, the scored rods are spirally wound around the balloon.

11. The scored balloon catheter according to any one of claims 1-9, characterized in that: The wire frame is made of a flexible material, and the thickness of the scored rods and / or the connecting wires is 0.1 - 0.5 mm.

12. The notched balloon catheter according to any one of claims 1-9, characterized in that: When in the expanded state, two adjacent scored rods and two adjacent connecting wires located between the two adjacent scored rods enclose a quadrilateral.

13. The notched balloon catheter according to claim 12, wherein: In the enclosed quadrilateral, the lengths of two adjacent scored rods are equal, and the lengths of two adjacent connecting wires are equal.

14. The notched balloon catheter according to any one of claims 1-9, characterized in that: The catheter includes a catheter seat disposed at the proximal end of the catheter, an outer tube disposed outside the balloon, and an inner tube disposed inside the balloon. The catheter has a first cavity for threading a guide wire and a second cavity for perfusing liquid or gas.

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