Cutting balloon

Abstract

The utility model provides a cutting balloon. The cutting balloon comprises a balloon body and a cutting assembly. The cutting assembly comprises a tool apron and a blade, the tool apron is provided with an upper surface and a lower surface which are opposite, the lower surface is attached to the outer surface of the balloon, the blade is provided with a bottom end and a tip end which are opposite, and the thickness of the blade tends to decrease from the bottom end to the tip end. The bottom end of the blade is embedded into the tool apron so that the upper surface of the tool apron can be higher than the bottom end of the blade. According to the cutting balloon, the bonding force between the blade and the balloon can be improved, and the surgical risk is greatly reduced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a cutting balloon. Background Art

[0002] Interventional therapy is a minimally invasive treatment, which is to introduce special catheters, guidewires and other precision instruments into the human body under the guidance of medical imaging equipment to diagnose and treat local diseases in the body. Due to its advantages of minimally invasive, safe, simple operation, good efficacy and rapid effect, it has become the third largest clinical treatment method alongside internal medicine and surgical treatment.

[0003] The balloon is an interventional treatment device frequently used in clinical medicine. The main principle is that when the balloon reaches the location of the lesion, the balloon expands to prop up the blood vessel, and corresponding treatment is performed at the location of the balloon expansion. Among them, the cutting balloon is a special balloon with 3-4 micro blades installed longitudinally on the balloon. Before the balloon reaches the lesion, the blades are tightly wrapped in a specially folded balloon material and will not damage normal blood vessels along the path. After the balloon reaches the lesion, the blades extend out of the balloon when the balloon is expanded and filled, causing a longitudinal incision in the vascular media, thereby safely and effectively cutting the vascular wall. However, there are a large number of adverse events with the cutting balloons currently on the market, in which the blades on the balloon fall off during surgery, posing a safety hazard. Utility Model Content

[0004] In order to solve the technical problems existing in the prior art, the present application provides a cutting balloon, which can improve the adhesion between the blade and the balloon and greatly reduce the risk of surgery.

[0005] In order to achieve the above objectives, the technical solutions provided by this application are as follows:

[0006] A cutting balloon comprises: a balloon and a cutting assembly; the cutting assembly comprises: a blade holder and a blade, the blade holder having a relative upper surface and a lower surface, the lower surface being in contact with the outer surface of the balloon, the blade having a relative bottom end and a tip end, the thickness of the blade decreasing from the bottom end to the tip end, the bottom end of the blade being embedded in the blade holder so that the upper surface of the blade holder is higher than the bottom end of the blade.

[0007] As a preferred embodiment, the balloon extends along a first longitudinal direction, and the cutting assembly comprises a plurality of cutting assemblies, which are arranged at intervals along the first longitudinal direction and / or arranged at intervals along the circumferential direction of the balloon, or offset in the circumferential direction of the balloon along the extension direction of the balloon.

[0008] As a preferred embodiment, one or more blades are arranged on the blade holder.

[0009] As a preferred embodiment, the balloon extends along a first longitudinal direction, and the plurality of blades are arranged on the blade holder along the first longitudinal direction and / or along a circumferential direction of the balloon.

[0010] As a preferred embodiment, a groove is arranged on the outer surface of the balloon, the groove is used to accommodate the blade holder, and at least the tip of the blade is exposed relative to the outer surface of the balloon.

[0011] As a preferred embodiment, a filler is provided between the groove and the cutting assembly, and the filler is used to solidify the tool holder.

[0012] As a preferred embodiment, the knife seat has a longitudinally extending main body, the main body has two opposite ends in the longitudinal extension direction, and the two ends of the knife seat are configured with arcs.

[0013] As a preferred embodiment, the bottom end of the blade is provided with an opening or roughened at a position where it contacts the blade seat.

[0014] As a preferred embodiment, a predetermined roughness is arranged on the outer surface of the balloon.

[0015] As a preferred embodiment, the outer surface of the balloon is bonded and fixed to the lower surface of the knife holder.

[0016] Beneficial effects:

[0017] The cutting balloon provided in the embodiment of the present application is fixedly connected to the blade by the blade holder, avoiding direct bonding between the balloon and the blade, thereby increasing the bonding area between the balloon and the cutting assembly and improving the bonding strength of the blade. In addition, the bottom end of the blade is embedded in the blade holder so that the upper surface of the blade holder is higher than the bottom end of the blade, ensuring the fixing strength between the blade and the blade holder, and then the blade holder is bonded as a whole to the outer surface of the balloon to prevent the blade from falling off the balloon surface.

[0018] With reference to the following description and drawings, the specific embodiments of the present application are disclosed in detail, indicating the manner in which the principles of the present application can be adopted. It should be understood that the embodiments of the present application are not limited in scope.

[0019] Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments, combined with features in other embodiments, or substituted for features in other embodiments.

[0020] It should be emphasized that the term “include / comprises” when used herein refers to the presence of features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps or components. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without paying any creative labor.

[0022] Figure 1 Shown is an axial cross-sectional view of the cutting balloon in an embodiment of the present application;

[0023] Figure 2 Shown is a cross-sectional view of the outer surface of the cutting balloon in an embodiment of the present application;

[0024] Figure 3 Shown is a balloon axonometric view of a cutting balloon in an embodiment of the present application;

[0025] Figure 4 Shown is an axonometric view of a cutting assembly in an embodiment of the present application;

[0026] Figure 5 Shown is an axial cross-sectional view of the cutting assembly in an embodiment of the present application;

[0027] Figure 6 Shown is a radial cross-sectional view of the cutting assembly in an embodiment of the present application;

[0028] Figure 7 Shown is an axial cross-sectional view of a cutting assembly having double blades in an embodiment of the present application;

[0029] Figure 8 Shown is an axial cross-sectional view of a cutting assembly having three blades in an embodiment of the present application;

[0030] Fig. 9 Shown is a schematic diagram of a cutting assembly in an embodiment of the present application having multiple rows of blades;

[0031] Fig.10 The figure shows a schematic diagram of a multi-blade structure of the blade of the cutting assembly in the embodiment of the present application.

[0032] Description of reference numerals:

[0033] 1. Balloon; 2. Cutting assembly; 21. Blade holder; 211. Upper surface; 212. Lower surface; 213. Arc structure; 22. Blade; 221. Bottom end; 222. Tip; 23. Opening; 3. Groove; 4. Middle gap; 5. Catheter shaft. DETAILED DESCRIPTION

[0034] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific implementation methods. It should be understood that these implementation methods are only used to illustrate the present invention and are not used to limit the scope. After reading the present invention, modifications of various equivalent forms of the present invention by those skilled in the art all fall within the scope defined in this application.

[0035] It should be noted that when an element is referred to as being "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0036] The following will be combined Figures 1 to 10 The cutting balloon of the embodiment of the present specification is explained and described. It should be noted that in the embodiment of the present utility model, the same reference numerals represent the same components. For the sake of brevity, the detailed description of the same components is omitted in different embodiments, and the descriptions of the same components can be referenced and quoted to each other.

[0037] The present specification provides a cutting balloon, comprising: a balloon 1 and a cutting assembly 2; the cutting assembly 2 comprises: a blade holder 21 and a blade 22, the blade holder 21 having a relative upper surface 211 and a lower surface 212, the lower surface 212 being in contact with the outer surface of the balloon 1, the blade 22 having a relative bottom end 221 and a tip 222, the thickness of the blade 22 tends to decrease from the bottom end 221 to the tip 222, the bottom end 221 of the blade 22 is embedded in the blade holder 21 so that the upper surface 211 of the blade holder 21 is higher than the bottom end 221 of the blade 22.

[0038] In the cutting balloon provided in the embodiment of the present application, the balloon 1 and the blade 22 are fixedly connected by the blade holder 21, so that the balloon 1 and the blade 22 are prevented from being directly bonded, thereby increasing the bonding area between the balloon 1 and the cutting assembly 2 and improving the bonding force of the blade 22. In addition, the bottom end of the blade 22 is embedded in the blade holder 21 so that the upper surface 211 of the blade holder 21 is higher than the bottom end 221 of the blade 22, thereby ensuring the fixing strength between the blade 22 and the blade holder 21, and then the blade holder 21 is bonded as a whole to the outer surface of the balloon 1 to prevent the blade 22 from falling off the surface of the balloon 1.

[0039] In this manual, if Figures 1 to 3As shown, the cutting balloon includes a balloon 1 connected to a catheter shaft 5. The balloon 1 has a cavity that can be filled with gas or liquid, and the balloon 1 has an inner surface located in the cavity and an outer surface opposite to the inner surface, and a cutting component 2 is arranged on the outer surface of the balloon 1. Generally speaking, the cutting balloon can be advanced along the guide wire, through the blood vessel, and reach the target lesion. Once positioned at the target position in the blood vessel, the balloon 1 can be inflated or injected with liquid, so that the cutting component 2 on the outer surface of the balloon 1 applies a radial outward force to the lesion to achieve the purpose of treatment.

[0040] Among them, the number and position of the cutting assembly 2 are not specifically limited. For example, it can include 1, 2, 3 or more, and these cutting assemblies 2 can be arranged at any position along the balloon 1, or multiple cutting assemblies 2 are arranged in a regular, irregular or any suitable manner. In order to be able to transport the cutting balloon along the guide wire, an inner tube member can be present in the catheter shaft 5, and the inner tube member includes an inner cavity for receiving the guide wire. In addition, the space between the inner tube member and the catheter shaft 5 can be used for gas injection or liquid injection, so that the space between the inner tube member and the catheter shaft 5 is connected to the cavity of the balloon 1 to allow the fluid medium to flow into and out of the balloon 1.

[0041] In some embodiments, the balloon 1 extends along a first longitudinal direction, and the cutting assembly 2 has a plurality of cutting assemblies 2: arranged at intervals along the first longitudinal direction and / or arranged at intervals along the circumferential direction of the balloon 1, or offset in the circumferential direction of the balloon 1 along the extension direction of the balloon 1.

[0042] In this embodiment, a plurality of cutting assemblies 2 may be arranged at intervals along the first longitudinal direction of the balloon 1, that is, a plurality of cutting assemblies 2 may be arranged at intervals along the entire length of the balloon 1; or a plurality of cutting assemblies 2 may be arranged at intervals along the circumferential direction of the balloon 1. Alternatively, under the premise of ensuring a sufficient number of cutting assemblies 2, some of the cutting assemblies 2 may be arranged at intervals along the first longitudinal direction of the balloon 1, and some of the cutting assemblies 2 may be arranged at intervals along the circumferential direction of the balloon 1. Alternatively, the cutting assemblies 2 may be offset in the circumferential direction of the balloon 1 along the extension direction of the balloon 1, that is, the cutting assemblies 2 may be distributed obliquely on the outer surface of the balloon 1.

[0043] like Figure 4 and Figure 6 As shown, the cutting assembly 2 includes a knife seat 21 and a blade 22. The knife seat 21 has an upper surface 211 and a lower surface 212 opposite to each other, and the lower surface 212 is in contact with the outer surface of the balloon 1. The blade 22 has a bottom end 221 and a tip 222 opposite to each other, and the thickness of the bottom end 221 is greater than the thickness of the tip 222. The bottom end 221 of the blade 22 is embedded from the upper surface 211 of the knife seat 21 into the interior of the knife seat 21, so that the knife seat 21 and the blade 22 form a stable connection.

[0044] The blade 22 and the blade holder 21 are in a long strip structure as a whole, and the outer contour size of the blade holder 21 is larger than the outer contour size of the blade 22. Preferably, the blade holder 21 is made of a polymer material. When making the cutting assembly 2, the bottom end 221 of the blade 22 is first wrapped with a polymer material to form the blade holder 21, and then the blade holder 21 is bonded to the outer surface of the balloon 1. Thus, the upper surface 211 of the blade holder 21 is higher than the bottom end 221 of the blade 22. The blade 22 can be made of any suitable material, such as metal, metal alloy, polymer, metal-polymer composite material, etc., or any other suitable material. For example, the blade 22 can be made of stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy or other metal materials.

[0045] In this specification, one or more blades 22 are arranged on the blade holder 21. Figures 7 to 9 As shown, the balloon 1 extends along a first longitudinal direction, and the plurality of blades 22 are on the blade holder 21 : arranged along the first longitudinal direction and / or along the circumferential direction of the balloon 1 .

[0046] Specifically, multiple blades 22 can be arranged longitudinally on the blade holder 21, or the blade holder 21 has a sufficient width to allow the blades 22 to be arranged transversely on the blade holder 21. When multiple blades 22 are arranged longitudinally on the blade holder 21, there is an intermediate gap 4 between the multiple blades 22, so that the cutting assembly 2 is a segmented structure, and when the cutting balloon passes through a tortuous blood vessel, the balloon 1 corresponding to the part of the cutting assembly 2 can be bent. When the cutting assembly 2 is designed as a segmented structure, in order to improve the passability of the balloon 1, the length and number of the blades 22 can be adjusted according to clinical needs to form products of different specifications. When multiple blades 22 are fixed on a blade holder 21, the lower surface 212 of the blade holder 21 is bonded and fixed to the outer surface of the balloon 1, so that multiple blades 22 can be fixed at the same time, and the bonding stability can be ensured.

[0047] When the plurality of blades 22 are arranged transversely on the blade holder 21, there may be a gap between the plurality of blades 22, or there may be no gap between the plurality of blades 22. Fig.10 As shown, the blade 22 is a multi-blade structure and may have a plurality of tips 222. The multi-row blades or multi-blade blades may increase the cutting marks on the target lesion site in the blood vessel when the cutting balloon is cut once.

[0048] In some embodiments, Figure 4 and Figure 5As shown, the blade holder 21 has a longitudinally extending body, and the body has two opposite ends in the longitudinal extension direction, and the two ends of the blade holder 21 are constructed with an arc. Specifically, the two ends of the blade holder 21 are designed as an arc structure 213 to ensure that the cutting balloon is prevented from being scratched by the blade holder 21 and other instruments when withdrawing. For example, therapeutic products such as cutting balloons will be delivered to the target position in the blood vessel through a sheath or a guide catheter, and when withdrawing the cutting balloon, it will also be withdrawn from the target position through the sheath or the guide catheter. When withdrawing, the two side edges of the cutting component 2 are made into an arc transition, which can prevent the cutting component 2 from being scratched by the guide catheter port, thereby reducing the risk of the blade 22 falling off.

[0049] In some embodiments, Figure 2 and Figure 3 As shown, a groove 3 is provided on the outer surface of the balloon 1, and the groove 3 is used to accommodate the knife seat 21, and at least the tip 222 of the blade 22 is exposed relative to the outer surface of the balloon 1. In this embodiment, a groove 3 is provided on the outer surface of the balloon 1, and the knife seat 21 is fixed in the groove 3 when being bonded and fixed to the outer surface of the balloon 1, so that the height of the cutting assembly 2 protruding from the outer surface of the balloon 1 as a whole is reduced, and the maximum outer diameter of the cutting balloon passing through the blood vessel is reduced. Thereby, it is possible to further avoid the knife seat 21 from scratching other instruments when the cutting balloon is withdrawn, and prevent the blade 22 from falling off the balloon 1 when the product is withdrawn.

[0050] Furthermore, a filler is provided between the groove 3 and the cutting assembly 2, and the filler is used to solidify the knife seat 21. The filler can be a kind of glue, which can fix the entire cutting assembly 2 in the groove 3 by heating and solidifying, and can cover all gaps between the cutting assembly 2 and the groove 3, so as to play a role of reinforcement and protection.

[0051] Furthermore, in order to correspond to the number of cutting components 2, the number of the grooves 3 is equivalent to the cutting components 2, the length and width of the grooves 3 need to be adjusted according to the length and width of the blade seat 21 on the cutting component 2, and the depth of the grooves 3 needs to ensure that at least the tip 222 of the blade 22 on the cutting component 2 can be exposed, so that the depth of the grooves 3 needs to be adjusted according to the distance from the tip 222 to the bottom 221 on the blade 22, and the height of the blade seat 21.

[0052] In some embodiments, Figures 5 to 8As shown, the bottom end 221 of the blade 22 is provided with an opening 23 or roughened at a position where it contacts the blade holder 21. The bottom end 221 of the blade 22 is provided with an opening 23 or roughened so that when the bottom end 221 of the blade 22 is wrapped with a polymer material, the bonding between the polymer material and the bottom end 221 of the blade 22 can be enhanced, that is, the blade 22 and the blade holder 21 are tightly bonded to prevent the two from being separated.

[0053] In some embodiments, a predetermined roughness is provided on the outer surface of the balloon 1. For example, when preparing the balloon 1, the inner surface of the mold thereof can be roughened, so that the outer surface of the balloon 1 can be ensured to have a certain roughness. Roughening the outer surface of the balloon 1 can improve the bonding strength between the cutting assembly 2 and the balloon 1. For another example, the balloon surface can be treated by plasma activation before bonding, which can also make the outer surface of the balloon 1 have a certain roughness.

[0054] The above embodiments are only for illustrating the technical concept and features of the present application, and their purpose is to enable people familiar with the technology to understand the content of the present application and implement it accordingly, and they cannot be used to limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit of the present application should be included in the protection scope of the present application.

[0055] It should be understood that the above description is for illustration and not for limitation. By reading the above description, many embodiments and many applications beyond the provided examples will be apparent to those skilled in the art. For comprehensive purposes, all articles and references, including the disclosures of patent applications and announcements, are incorporated herein by reference.

Claims

1. A cutting balloon, characterized in that: include: balloon and cutting assembly; The cutting assembly includes: a blade seat and a blade, the blade seat having relative upper and lower surfaces, the lower surface being in contact with the outer surface of the balloon, the blade having relative bottom ends and tip ends, the thickness of the blade decreasing from the bottom end to the tip end, the bottom end of the blade being embedded in the blade seat so that the upper surface of the blade seat is higher than the bottom end of the blade.

2. The cutting balloon according to claim 1, characterized in that: The balloon extends along a first longitudinal direction, and the cutting components include a plurality of cutting components, which are arranged at intervals along the first longitudinal direction and / or arranged at intervals along the circumferential direction of the balloon, or offset in the circumferential direction of the balloon along the extension direction of the balloon.

3. The cutting balloon according to claim 1, characterized in that: One or more blades are arranged on the blade seat.

4. The cutting balloon according to claim 3, characterized in that: The balloon extends along a first longitudinal direction, and the plurality of blades are arranged on the blade holder along the first longitudinal direction and / or along a circumferential direction of the balloon.

5. The cutting balloon according to claim 1, characterized in that: A groove is arranged on the outer surface of the balloon, the groove is used to accommodate the blade seat, and at least the tip of the blade is exposed relative to the outer surface of the balloon.

6. The cutting balloon according to claim 5, characterized in that: A filler is arranged between the groove and the cutting assembly, and the filler is used to solidify the tool holder.

7. The cutting balloon according to claim 1, characterized in that: The knife seat has a longitudinally extending main body, wherein the main body has two opposite ends in the longitudinal extending direction thereof, and the two ends of the knife seat are configured with arcs.

8. The cutting balloon according to claim 1, wherein: The bottom end of the blade is provided with an opening or roughened at a position where it contacts the blade seat.

9. The cutting balloon according to claim 1, characterized in that: A predetermined roughness is arranged on the outer surface of the balloon.

10. The cutting balloon according to claim 1, wherein: The outer surface of the balloon is bonded and fixed to the lower surface of the knife seat.

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