Cutting balloon and preparation tool thereof

Abstract

The cutting balloon comprises a balloon body and a plurality of blade assemblies arranged on the outer wall of the balloon body in the axial direction, each blade assembly comprises a blade and a tool apron, and each blade is of a long-strip-shaped structure and comprises a cutting edge perpendicular to the outer wall of the balloon body and back on to the balloon body; the blade holder is of a sheet-shaped structure and used for fixing the blade to the balloon. The tool apron comprises a connecting part and reinforcing parts, the connecting part is of a long-strip-shaped structure, and the reinforcing parts are of a tooth-shaped structure and connected to the two sides, extending in the axial direction, of the connecting part. The top face of the connecting part is used for being connected with a blade, the bottom face of the connecting part and the bottom face of the reinforcing part are fixed to the outer wall of the balloon through adhesive, and tooth-shaped gaps of the reinforcing part are filled with the adhesive. The invention further provides a preparation method of the cutting balloon. The cutting balloon is simple in structure, and the blade assembly is firmly connected with the balloon.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a cutting balloon and a preparation tool thereof. Background Art

[0002] Cardiovascular and cerebrovascular diseases are associated with high morbidity, mortality, and disability rates. Diseases such as atherosclerosis can cause blood vessel blockage or narrowing, which can lead to severe consequences such as cardiac oxygen deprivation and stroke.

[0003] Current treatments for vascular occlusion and stenosis include percutaneous transluminal angioplasty (PTA), percutaneous transluminal coronary angioplasty (PTCA), and plaque resection. Angioplasty techniques typically involve the use of a balloon catheter, which is positioned near the stenotic lesion and then inflated to dilate the vessel. However, conventional balloon expansion can cause plaque compression and rupture, as well as elastic expansion of the vessel. This elastic recoil can easily lead to restenosis and is ineffective against certain types of sclerotic lesions. The cutting balloon is an interventional treatment developed based on traditional angioplasty. It consists of a balloon and several metal blades mounted longitudinally on its surface. Before reaching the lesion, the blades are tightly wrapped within the folded balloon. After reaching the lesion and inflating the balloon, the blades extend from the balloon, creating an incision in the tunica media, thereby treating the sclerotic lesion and reducing restenosis.

[0004] Existing cutting balloons on the market typically mount the blade on a mounting base, which is then attached to the balloon's outer wall via gluing or other methods to secure the blade. However, this mounting method can easily lead to oversizing, and the blade can easily lift from the base or even fall off during balloon delivery. Summary of the Invention

[0005] Based on this, the purpose of the present invention is to provide a cutting balloon and its preparation tooling, which are used to solve the problem that the blade assembly on the cutting balloon in the prior art is difficult to install and easy to fall off.

[0006] One object of the present invention is to provide a cutting balloon, comprising a balloon and a plurality of blade assemblies axially arranged on the outer wall of the balloon, wherein the blade assembly comprises blades and a blade holder, wherein the blades have an elongated structure and include cutting edges perpendicular to the outer wall of the balloon and facing away from the balloon; the blade holder has a sheet-like structure for fixing the blades on the balloon; The blade holder includes a connecting part and a reinforcing part, the connecting part has a long strip structure, and the reinforcing part has a tooth-like structure, which is connected to both sides of the connecting part extending axially; the top surface of the connecting part is used to connect the blade, and the bottom surfaces of the connecting part and the reinforcing part are fixedly connected to the outer wall of the balloon by an adhesive, and the adhesive is filled in the tooth-like gap of the reinforcing part.

[0007] Furthermore, the blade assembly is integrally formed from one or more materials selected from stainless steel, nickel-titanium alloy, cobalt-based alloy, magnesium-lithium alloy, nickel-iron alloy, and tungsten steel; and the blade angle of the blade is 15-45°.

[0008] Furthermore, the number of the multiple blade assemblies is 2 to 6 groups, and they are evenly spaced and arranged in the circumferential direction of the outer wall of the balloon.

[0009] Furthermore, the bottom surface of the knife holder has a curved surface structure adapted to the outer wall of the balloon when it is inflated.

[0010] Furthermore, the knife holder has a plurality of grooves distributed on the bottom surface, and the grooves are recessed inwards. When the bottom surface of the knife holder is bonded to the outer wall of the balloon, the grooves are filled with adhesive.

[0011] Furthermore, the length of the blade is 5-200 mm; the height of the blade along the radial direction of the balloon is 0.1-0.4 mm; and the width of the bottom of the blade is 0.1-0.2 mm.

[0012] Furthermore, the connecting portion has a rectangular structure, the length of the connecting portion is not less than the length of the blade, the width of the connecting portion is not less than the width of the bottom of the blade, the length of the connecting portion is 5~200mm; the width is 0.1~0.2mm; and the thickness is 0.05~0.2mm.

[0013] Furthermore, the reinforcing portion includes a plurality of racks extending to both sides along the width direction of the connecting portion, the racks having a rectangular sheet structure, the length of the racks extending along the circumference of the balloon being 0.1~0.3mm; the width along the extension direction of the connecting portion being 0.05~0.1mm, and the spacing between two adjacent racks being 0.01~0.2mm.

[0014] A second object of the present invention is to provide a cutting balloon preparation tool for assembling any of the above-mentioned cutting balloons, the preparation tool comprising a sleeve, the radial dimension of the sleeve being slightly larger than the radial dimension of the inflated balloon; the sleeve being provided with a plurality of slots extending through the sidewall, the number of the slots being the same as the number of the blade assemblies, the length of the slots being greater than the length of the blades, and the width being less than the width of the blade holder; The plurality of blades are respectively passed through the inner cavity of the sleeve through the slot to the outside of the sleeve, and the balloon is filled so that the outer wall of the balloon is close to the bottom of each blade assembly. Glue is applied between the balloon and the blade assembly to achieve the assembly of the cutting balloon.

[0015] Furthermore, the width of the slot is slightly larger than the width of the bottom of the blade.

[0016] The cutting balloon provided by the present invention has a simple structure. By providing a reinforcement portion with a serrated structure, the adhesive can fully bond to the blade holder during the bonding process of the blade assembly, thereby making the bonding of the blade assembly stable and firm; the preparation tooling provided by the present invention has a simple structure. By controlling the filling degree of the balloon, the amount of glue dispensed between the outer wall of the balloon and the blade holder can be adjusted, thereby adjusting the height of the blade. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0018] Figure 1 Schematic diagram of the structure of the cutting balloon in the first embodiment.

[0019] Figure 2 It is a side view of the blade assembly in the first embodiment.

[0020] Figure 3 It is a front view of the blade assembly in the first embodiment.

[0021] Figure 4 It is a top view of the tool holder in the first embodiment.

[0022] Figure 5 It is a structural diagram of the preparation tooling in the second embodiment.

[0023] Figure 6 Schematic diagram of assembling a cutting balloon using the tooling prepared in the second embodiment.

[0024] Figure 7 for Figure 6 Cross-sectional view at the AA position.

[0025] Figure 8 for Figure 7 A partial enlarged view of position B in the middle. DETAILED DESCRIPTION

[0026] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0027] In this specification, the proximal end refers to the end closer to the operator during surgery, and the distal end refers to the end farther away from the operator during surgery.

[0028] The present invention provides a cutting balloon, comprising a balloon and a plurality of blade assemblies axially arranged on the outer wall of the balloon, wherein the blade assembly comprises a blade and a blade holder, wherein the blade has an elongated structure and comprises a cutting edge perpendicular to the outer wall of the balloon and facing away from the balloon; the blade holder has a sheet-like structure and is used to fix the blade on the balloon; the blade holder comprises a connecting portion and a reinforcing portion, wherein the connecting portion has an elongated structure and the reinforcing portion has a tooth-like structure and is connected to both sides of the connecting portion extending along the axial direction; the top surface of the connecting portion is used to connect the blade, and the bottom surfaces of the connecting portion and the reinforcing portion are fixedly connected to the outer wall of the balloon by an adhesive, and the adhesive is filled in the tooth-like gap of the reinforcing portion.

[0029] The cutting balloon provided by the present invention has a simple structure. By providing a tooth-shaped reinforcement part, the use of blade holder material can be reduced, thereby improving the overall flexibility of the balloon; at the same time, the contact area between the adhesive and the blade holder can be increased, so that the balloon and the blade assembly are tightly and firmly connected.

[0030] refer to Figures 1 to 3 The first embodiment of the present invention provides a cutting balloon 10, comprising a catheter 11, a balloon 12 and a plurality of blade assemblies 13, wherein the balloon 12 is wrapped around the distal end of the catheter 11; the plurality of blade assemblies 13 are axially arranged on the outer wall of the balloon 12, and the blade assembly 13 includes a blade 131 and a blade holder 132, wherein the blade 131 has a long strip structure, including a blade perpendicular to the outer wall of the balloon 12 and facing away from the balloon 12; the blade holder 132 has a sheet structure for fixing the blade 131 Fixed on the balloon 12; the blade holder 132 includes a connecting portion 132a and a reinforcing portion 132b, the connecting portion 132a has a long strip structure; the reinforcing portion 132b has a tooth-like structure, connected to both sides of the connecting portion 132a extending along the axial direction; the top surface of the connecting portion 132a is used to connect the blade 131, and the bottom surfaces of the connecting portion 132a and the reinforcing portion 132b are fixedly connected to the outer wall of the balloon 12 by an adhesive, and the adhesive is filled in the tooth-like gap of the reinforcing portion 132b.

[0031] In the present invention, the blade assembly 13 is integrally formed from one or more materials selected from stainless steel, nickel-titanium alloy, cobalt-based alloy, magnesium-lithium alloy, nickel-iron alloy, and tungsten steel; the blade has an angle of 15 to 45 degrees. The blade assembly 13 provided on the cutting balloon has excellent wear resistance.

[0032] In the present invention, the number of blade assemblies 13 can be 2-6, and the plurality of blade assemblies 13 are evenly spaced along the circumference on the outer wall of the balloon 12. This solution can balance the size of the cutting balloon and the treatment effect.

[0033] refer to Figure 3 The bottom surface of the knife seat 132 has a curved surface structure that matches the outer wall of the balloon when it is filled. Specifically, the radial cross-section of the bottom surface of the knife seat 132 has the same circumferential curvature as the radial cross-section of the balloon wall when it is filled.

[0034] Furthermore, the bottom surface of the blade holder 132 has multiple grooves. When the bottom surface of the blade holder 132 is bonded to the outer wall of the balloon 12, the grooves are filled with adhesive. This solution increases the friction coefficient of the bottom surface of the blade holder 132, making the bond between the blade holder and the balloon more secure. At the same time, when the bottom surface of the blade holder is bonded to the outer wall of the balloon via adhesive, the adhesive can fill the grooves, further improving the bond strength.

[0035] Furthermore, the length of the blade 131 is 5-200 mm; the height of the blade along the radial direction of the balloon is 0.1-0.4 mm; and the width of the bottom of the blade is 0.1-0.2 mm.

[0036] Furthermore, the connecting portion 132a has a rectangular structure, the length of which is not less than the length of the blade 131, and the width of which is not less than the width of the bottom of the blade.

[0037] Specifically, the length of the connecting portion 132 a is 5 to 200 mm, the width is 0.1 to 0.2 mm, and the thickness is 0.05 to 0.2 mm.

[0038] Furthermore, the reinforcing portion 132b includes a plurality of racks extending to both sides along the width direction of the connecting portion 132a. The racks have a rectangular sheet structure, and the length of the racks extending along the circumference of the balloon is 0.1~0.3mm; the width along the extension direction of the connecting portion 132a is 0.05~0.1mm, and the spacing between two adjacent racks is 0.01~0.2mm.

[0039] refer to Figure 5 The second embodiment of the present invention provides a preparation tool 20 for a cutting balloon, which is used to assemble the cutting balloon 10 provided in the above embodiment. The preparation tool 20 includes a sleeve 21, and the radial dimension of the sleeve 21 is slightly larger than the radial dimension of the filled balloon 12; the sleeve 21 is provided with a plurality of slots 22 passing through the side wall, and the number of the slots 22 is the same as the number of the blade assembly 13. The length of the slot 22 is greater than the length of the blade 131, and the width is less than the width of the blade seat 132.

[0040] refer to Figures 6 to 8The steps of making a cutting balloon using the above-mentioned preparation tool 20 are as follows: the blades 131 of multiple blade assemblies 13 are passed through the inner cavity of the sleeve 21 through the slot 22 to the outside of the sleeve 21; the balloon catheter assembly is inserted into the inner cavity of the sleeve 21, the balloon 12 is filled so that its outer wall is close to the bottom surface of each blade assembly 13, and glue is applied between the balloon 12 and the bottom surface of the blade assembly 13. After the adhesive is cured, the cutting balloon 10 can be assembled.

[0041] The manufacturing tooling provided in this embodiment can control the thickness of the glue dispensed by controlling the filling degree of the balloon 12, that is, the height of the blade (the height between the blade and the outer wall of the balloon) can be adjusted.

[0042] Furthermore, the width of the slot 22 is slightly larger than the width of the bottom of the blade 131. With the manufacturing tool provided in this solution, when the blade passes through the slot 22, the bottom of the blade abuts against the edge of the slot 22. The manufacturing tool provided in this solution can fully pressurize the balloon when it is inflated, thereby making the blade assembly more tightly bonded.

[0043] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or make equivalent replacements for some or all of the technical features therein. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A cutting balloon, characterized in that: The invention comprises a balloon and a plurality of blade assemblies axially arranged on the outer wall of the balloon, wherein the blade assembly comprises blades and a blade holder, wherein the blades have an elongated structure and include cutting edges perpendicular to the outer wall of the balloon and facing away from the balloon; the blade holder has a sheet-like structure and is used to fix the blades on the balloon; The blade holder includes a connecting part and a reinforcing part, the connecting part has a long strip structure, and the reinforcing part has a tooth-like structure, which is connected to both sides of the connecting part extending axially; the top surface of the connecting part is used to connect the blade, and the bottom surfaces of the connecting part and the reinforcing part are fixedly connected to the outer wall of the balloon by an adhesive, and the adhesive is filled in the tooth-like gap of the reinforcing part.

2. The cutting balloon according to claim 1, wherein: The blade assembly is integrally formed from one or more materials selected from stainless steel, nickel-titanium alloy, cobalt-based alloy, magnesium-lithium alloy, nickel-iron alloy, and tungsten steel; and the blade angle is 15-45°.

3. The cutting balloon according to claim 1, wherein: The number of the multiple blade assemblies is 2 to 6 groups, and they are evenly spaced and arranged in the circumferential direction of the outer wall of the balloon.

4. The cutting balloon according to claim 3, characterized in that The bottom surface of the knife seat has a curved surface structure adapted to the outer wall of the balloon when it is inflated.

5. The cutting balloon according to claim 4, characterized in that The bottom surface of the knife holder is provided with a plurality of grooves. When the bottom surface of the knife holder is bonded to the outer wall of the balloon, the grooves are filled with adhesive.

6. The cutting balloon according to claim 1, characterized in that The length of the blade is 5-200 mm; the height of the blade along the radial direction of the balloon is 0.1-0.4 mm; and the width of the bottom of the blade is 0.1-0.2 mm.

7. The cutting balloon according to claim 6, characterized in that The connecting portion has a rectangular structure, the length of the connecting portion is not less than the length of the blade, the width of the connecting portion is not less than the width of the bottom of the blade, the length of the connecting portion is 5 to 200 mm, and the width is 0.1 to 0.2 mm; The thickness is 0.05~0.2mm.

8. The cutting balloon according to claim 7, characterized in that The reinforcing part includes a plurality of racks extending to both sides along the width direction of the connecting part. The racks have a rectangular sheet structure. The length of the racks extending along the circumference of the balloon is 0.1~0.3mm; the width along the extension direction of the connecting part is 0.05~0.1mm, and the spacing between two adjacent racks is 0.01~0.2mm.

9. A cutting balloon preparation tool for assembling the cutting balloon according to any one of claims 1 to 8, characterized in that: The preparation tool comprises a sleeve, the radial dimension of which is slightly larger than the radial dimension of the inflated balloon; the sleeve is provided with a plurality of slots penetrating the side wall, the number of the slots being the same as the number of the blade assemblies, the length of the slots being larger than the length of the blades, and the width being smaller than the width of the blade holder; The blades of the multiple blade assemblies are respectively passed through the inner cavity of the sleeve through the slot to the outside of the sleeve, and the balloon is filled so that the outer wall of the balloon is close to the bottom surface of each blade assembly. Glue is applied between the balloon and the blade assembly to achieve the assembly of the cutting balloon.

10. The cutting balloon preparation tool according to claim 9, characterized in that: The width of the slot is slightly larger than the width of the bottom of the blade.

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