A cutting balloon

Abstract

The utility model discloses a cutting balloon, it includes: push rod, balloon head and inflation pipeline, the balloon head fixed setting in push rod one end, push rod is used for adjusting the balloon head reaches corresponding position, the balloon head sets up blade, inflation pipeline with balloon head intercommunication, through inflation pipeline to balloon head inflation, the balloon head inflation will the blade push out, to execute cutting action. The cutting balloon of the utility model can solve the problem that the middle occlusion section is located in the subintimal false lumen.

Description

Technical Field

[0001] This utility model relates to chronic occlusive lesions, and more specifically to a cutting balloon. Background Technology

[0002] Following successful interventional treatment of chronic total occlusion (CTO), a subintimal false lumen often exists within the occluded segment. Stent implantation at this point can lead to the loss of branch vessels within the false lumen segment and an increased rate of in-stent restenosis. For clinical CTO lesions, after opening the occluded segment via guidewire alone or antegrade dissection re-entry (ADR), in cases where the proximal and distal occluded segments are within the true lumen while the intermediate segment is subintimal, effectively converting this subintimal false lumen into a true lumen is crucial for achieving optimal treatment outcomes for CTO patients. Currently, there are no medical devices developed and used domestically or internationally to bridge the true and false lumens of coronary arteries.

[0003] The information in the background section is merely intended to illustrate the general background of this invention and should not be construed as an admission or implication in any way that such information constitutes prior art known to those skilled in the art. Utility Model Content

[0004] To address at least some of the technical problems in the prior art, this utility model provides a cutting balloon. Specifically, this utility model includes the following:

[0005] A first aspect of this utility model provides a cutting balloon, comprising: a push rod, a balloon head end, an inflation tube, and a single-arm balloon connected to the head end; the balloon head end is fixedly disposed at one end of the push rod, and the push rod is used to adjust the position of the balloon head end; a blade is disposed at the balloon head end; the inflation tube communicates with the balloon head end and the single-arm balloon; air is inflated to the balloon head end through the inflation tube, and the balloon head end expands to push out the blade to perform a cutting action.

[0006] In some embodiments, a unilateral arm balloon is disposed near the blade at the balloon tip; the unilateral arm balloon is in communication with the balloon tip; when the inflation tubing is not inflating the balloon tip and the unilateral arm balloon, the unilateral arm balloon covers the blade; when the inflation tubing inflates the balloon tip and the unilateral arm balloon, the unilateral arm balloon inflates and exposes the blade.

[0007] In some embodiments, the unilateral arm balloon is provided with a balloon groove near the blade, the balloon groove being used to accommodate the blade when the unilateral arm balloon is not inflated.

[0008] In some embodiments, wherein the unilateral arm balloon is inflated, the unilateral arm balloon gradually tapers from its tail end to its tip; wherein the portion of the unilateral arm balloon connected to the balloon head end is the tail end of the unilateral arm balloon, and the portion of the unilateral arm balloon away from the balloon head end is the tip of the unilateral arm balloon.

[0009] In some embodiments, the outer diameter of the lumen of the unilateral arm balloon is 2 mm or 1.5 mm when the unilateral arm balloon is inflated.

[0010] In some embodiments, the blade is 1 mm or 1.2 mm in length.

[0011] In some embodiments, the balloon tip is made of PTFE.

[0012] In some embodiments, the push rod is a hollow structure along its length, and the inflation tube is disposed in the hollow structure of the push rod.

[0013] In some embodiments, the outer diameter of the balloon tip is 1.5 mm.

[0014] In some embodiments, a guidewire guiding cavity is further included, which is disposed on the outer side of the balloon tip; the guidewire guiding cavity is used to guide the travel path of the balloon tip.

[0015] The cutting balloon of this invention solves the problem of the false cavity located under the intima in the middle occlusion segment, so that the entire occlusion segment is a true cavity.

[0016] It should be understood that the above general description and the following specific embodiments are merely exemplary and illustrative, and do not limit the scope of the present invention. Attached Figure Description

[0017] The accompanying drawings are part of the specification of this utility model and illustrate exemplary embodiments of the utility model. The drawings, together with the description in the specification, are used to illustrate the principles of the utility model.

[0018] Figure 1 This is a schematic diagram of the cutting balloon in an inflated state according to an embodiment of the present invention;

[0019] Figure 2 This is a schematic diagram of the cutting balloon in an uninflated state according to an embodiment of the present invention;

[0020] Figure 3 This is a schematic diagram of the balloon tip in an inflated state according to an embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of the balloon tip in an uninflated state according to an embodiment of the present invention.

[0022] Explanation of reference numerals in the attached figures:

[0023] 1-Push rod; 2-Balloon tip; 3-Blade; 4-Single arm balloon; 5-Balloon groove; 6-Pressure pump inflation port; 7-Guide wire guide cavity. Detailed Implementation

[0024] Various exemplary embodiments of the present invention are now described in detail. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, features and implementations of the present invention.

[0025] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, regarding numerical ranges in this invention, it should be understood that the upper and lower limits of the range and each intermediate value between them are specifically disclosed. Any stated value or intermediate value within a stated range, as well as any other stated value or each smaller range between intermediate values ​​within a range, are also included within this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0026] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to literature in this specification are incorporated by way of citation to disclose and describe the methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail. Unless otherwise stated, “%” means percentage based on weight.

[0027] The directional terms used in the following description refer to the directions shown in the figures and are not intended to limit the specific structure of the embodiments of this utility model. In the description of this utility model, it should be noted that, unless otherwise stated, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0028] Furthermore, the terms "comprising," "including," "having," or any other variations thereof are intended to cover non-exclusive inclusion, such that a structure or component that includes a list of elements includes not only those elements but also other structural elements that are not expressly listed or inherent to the structure or component. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the article or apparatus that includes the element.

[0029] Spatial relation terms such as "below," "under," "under," "low," "above," "on," and "high" are used for descriptive convenience to explain the positioning of one element relative to a second element, indicating that these terms are intended to cover different orientations of the device, in addition to those different from those shown in the figure. Furthermore, phrases such as "one element on / below another element" can indicate that two elements are in direct contact, or that there are other elements between the two elements. In addition, terms such as "first" and "second" are also used to describe individual elements, areas, parts, etc., without specifically indicating order or sequence, and should not be considered restrictive. Similar terms are used throughout the description to represent similar elements.

[0030] Example

[0031] like Figure 1 and 2 As shown, this utility model provides a cutting balloon, including: a push rod 1, a balloon head end 2, and an inflation tube. The balloon head end 2 is fixedly disposed at one end of the push rod 1, and the push rod 1 is used to adjust the position of the balloon head end 2. A blade 3 is disposed on the balloon head end 2. The inflation tube is connected to the balloon head end 2. Inflation is performed on the balloon head end 2 through the inflation tube, and the balloon head end 2 expands to push out the blade 3, thereby performing a cutting action on the inner membrane of the true and false cavities.

[0032] In this embodiment, the pusher 1 is used to push the balloon tip 2 to the intima flap near the true and false lumen. Inflation of the balloon tip 2 is performed through the inflation tubing (e.g., using 12 atm pressure). The blade 3 positioned on the balloon tip 2 is then pushed out to penetrate the intima flap, completing the cutting of the true and false lumen intima, thus converting the false lumen segment into a full true lumen. For example, the inflation tubing can be located inside the pusher 1. Using this cutting balloon to penetrate the true and false lumen of the coronary artery can open the occluded segment in CTO patients, maximizing the preservation of side branches, and expanding the indications for ADR technology. For example, this application is particularly suitable for vessels with large branches in the occluded segment (e.g., left anterior descending artery, LAD). Furthermore, using this cutting balloon to penetrate the true and false lumen of the coronary artery can further improve the CTO patency rate, reduce operation time, radiation and contrast agent dosage, and improve patient prognosis.

[0033] According to one embodiment of this utility model, a unilateral balloon 4 is disposed at the balloon tip 2 near the blade 3. The unilateral balloon 4 is connected to the balloon tip 2. When the inflation tubing is not inflating the balloon tip 2 and the unilateral balloon 4, the unilateral balloon 4 covers the blade 3. When the inflation tubing inflates the balloon tip 2 and the unilateral balloon 4, the unilateral balloon 4 expands, exposing the blade 3.

[0034] In this embodiment, the inflation tubing, the balloon tip 2, and the unilateral arm balloon 4 can be an integrated structure that is connected to each other. For example, when the inflation tubing inflates the balloon tip 2 and the unilateral arm balloon 4, the expansion of the unilateral arm balloon 4 exposes the blade 3, placing the blade 3 between the push rod 1 and the unilateral arm balloon 4.

[0035] like Figure 3 and 4 As shown, according to one embodiment of the present invention, a balloon groove 5 is provided near the blade 3 in the unilateral arm balloon 4. The balloon groove 5 is used to accommodate the blade 3 when the unilateral arm balloon is not inflated.

[0036] In this embodiment, for example, the balloon groove 5 can be made of a material that is not easily scratched by sharp objects.

[0037] For example, a unilateral arm balloon 4 is positioned on the side of the balloon tip 2 near the push rod 1, and a blade 3 is positioned between the unilateral arm balloon 4 and the push rod 1 (i.e., spaced apart from the push rod when the unilateral arm balloon is inflated). When the balloon tip 2 and the unilateral arm balloon 4 are not inflated, the blade 3 is located in the balloon groove 5. Using the push rod 1, the balloon tip 2 is pushed to the inner membrane near the true and false lumens. Inflation is then performed on the balloon tip 2 and the unilateral arm balloon 4 through the inflation tubing. The balloon tip 2 expands, separating the unilateral arm balloon 4 from the push rod 1 and pushing out the blade 3 hidden in the balloon groove 5. At this point, the inflated unilateral arm balloon 4 is located in the true lumen. Pulling back the push rod 1 causes the inner membrane of the true and false lumens to be sandwiched between the push rod 1 and the unilateral arm balloon 4. The blade is located on the inner membrane of the true and false lumens and cuts the inner membrane located in the true and false lumens.

[0038] According to one embodiment of the present invention, when the unilateral arm balloon 4 is inflated, the unilateral arm balloon 4 gradually tapers from its tail end to its tip. 。 The portion of the unilateral arm balloon 4 that connects to the balloon head end 2 is the tail end of the unilateral arm balloon 4, and the portion of the unilateral arm balloon 4 furthest from the balloon head end 2 is the tip end of the unilateral arm balloon 4. When the unilateral arm balloon 4 is inflated, it gradually tapers from the tail end to the tip end.

[0039] In this embodiment, for example, the pusher 1 is used to push the balloon tip 2 to the intima flap near the true and false lumen. Inflation is then performed on the balloon tip 2 and the unilateral balloon 4 via the inflation tubing, with the tip of the unilateral balloon 4 pointing towards the proximal end of the coronary artery. The unilateral balloon 4 gradually tapers from its tail end to its tip. ， It facilitates the passage of a unilateral arm balloon through the true cavity compressed by the hematoma. 。

[0040] According to one embodiment of the present invention, the outer diameter of the lumen of a unilateral arm balloon in the inflated state is designed based on the true inner diameter of the lumen.

[0041] In this embodiment, for example, when the unilateral arm balloon is inflated, the outer diameter of the lumen of the unilateral arm balloon is 2 mm or 1.5 mm.

[0042] According to one embodiment of the present invention, the length of the blade 3 is 1 mm or 1.2 mm.

[0043] In this embodiment, for example, the length of the blade 3 is 1 mm or 1.2 mm. This is only used as an example to illustrate the length of the blade 3 and is not intended to limit the scope of protection of this utility model.

[0044] In this embodiment, for example, the width of the blade 3 can be 1 mm.

[0045] According to one embodiment of the present invention, the balloon tip 2 is made of PTFE material.

[0046] In this embodiment, for example, the balloon tip 2 can be made of soft PTFE material.

[0047] According to one embodiment of the present invention, the push rod 1 is a hollow structure along its length, and an inflation tube is disposed in the hollow structure of the push rod 1.

[0048] In this embodiment, for example, the push rod 1 can be a hollow structure. One end of the push rod 1 is provided with a pressure pump inflation port 6, which is used to connect to an inflation device to inflate the balloon head end 2 (and the single-arm balloon 4) provided at the other end of the push rod 1.

[0049] According to one embodiment of the present invention, the outer diameter of the balloon tip 2 is 1.5 mm.

[0050] In this embodiment, the balloon tip 2 is larger than that of a normal balloon tip, which makes it easier to retract the blade 3 when it is not inflated.

[0051] like Figure 1 and 2As shown, according to one embodiment of the present invention, in addition to the push rod 1, the balloon tip 2, and the inflation tubing, the cutting balloon also includes a guide wire guiding cavity 7, which is disposed on the outer side of the balloon tip 2. The guide wire guiding cavity 7 is used to guide the travel path of the balloon tip 2.

[0052] In this embodiment, the guidewire guiding lumen 7 is used to guide the balloon tip 2 along the guidewire into the corresponding blood vessel location, so as to approach or move away from the intima patch of the true and false lumen. For example, after the balloon tip 2 enters the proximal true lumen, negative pressure is applied to aspirate the gas, causing the balloon groove 5 of the unilateral arm balloon 4 to close again and cover the blade 3 at the balloon tip 2. At the same time, the balloon tip 2 and the unilateral arm balloon 4 retract and fit tightly against the push rod 1, exiting the body along the guiding catheter.

[0053] Although this invention has been described with reference to exemplary embodiments, it should be understood that this invention is not limited to the disclosed exemplary embodiments. Various adjustments or changes may be made to the exemplary embodiments of this invention without departing from the scope or spirit of this invention. The scope of the claims should be based on the broadest interpretation to cover all modifications and equivalent structures and functions.

Claims

1. A cutting balloon, comprising: The balloon includes a push rod, a balloon head, and an inflation tubing; the balloon head is fixedly mounted on one end of the push rod, and the push rod is used to adjust the position of the balloon head; the balloon head is equipped with a blade. The inflation line is connected to the balloon tip; air is inflated into the balloon tip through the inflation line, and the balloon tip expands to push out the blade to perform a cutting action.

2. The cutting balloon according to claim 1, wherein a unilateral arm balloon is disposed at the balloon tip near the blade; the unilateral arm balloon is in communication with the balloon tip; when the inflation line is not inflating the balloon tip and the unilateral arm balloon, the unilateral arm balloon covers the blade; when the inflation line inflates the balloon tip and the unilateral arm balloon, the balloon tip and the unilateral arm balloon expand and expose the blade.

3. The cutting balloon according to claim 2, wherein the unilateral arm balloon is provided with a balloon groove near the blade, the balloon groove being used to accommodate the blade when the unilateral arm balloon is not inflated.

4. The cutting balloon according to claim 2, wherein the unilateral arm balloon, when inflated, gradually tapers from its tail end to its tip; wherein the portion of the unilateral arm balloon connected to the balloon head end is the tail end of the unilateral arm balloon, and the portion of the unilateral arm balloon away from the balloon head end is the tip of the unilateral arm balloon.

5. The cutting balloon according to claim 4, wherein the outer diameter of the lumen of the unilateral arm balloon is 2 mm or 1.5 mm when the unilateral arm balloon is inflated.

6. The cutting balloon according to claim 1, wherein the length of the blade is 1 mm or 1.2 mm.

7. The cutting balloon according to claim 1, wherein the balloon tip is made of PTFE material.

8. The cutting balloon according to claim 1, wherein the push rod is a hollow structure along its length, and the inflation tube is disposed in the hollow structure of the push rod.

9. The cutting balloon according to claim 1, wherein the outer diameter of the balloon tip is 1.5 mm.

10. The cutting balloon according to claim 1, characterized in that, It also includes a guidewire guiding cavity, which is disposed on the outer side of the balloon tip; the guidewire guiding cavity is used to guide the travel path of the balloon tip.

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