Cutting balloon

Abstract

The invention discloses a cutting balloon which comprises a push rod, a balloon head end and an inflation pipeline. The head end of the balloon is fixedly arranged at one end of the pushing rod, and the pushing rod is used for adjusting the head end of the balloon to reach the corresponding position; a blade is arranged at the head end of the balloon; the inflating pipeline is arranged on the inner side of the pushing rod and is communicated with the head end of the balloon; the head end of the balloon is inflated through the inflation pipeline, and the head end of the balloon expands to push out the blade so as to execute the cutting action. The cutting balloon can solve the problem that the middle closed section is located in a false cavity below an intima.

Description

Technical Field

[0001] The invention relates to chronic occlusive lesions, and in particular to a cutting balloon. Background Art

[0002] After successful interventional treatment of chronic total occlusion (CTO), there is often a subintimal false lumen in the occluded segment. Once a stent is implanted at this time, it may cause the loss of branch vessels in the false lumen segment and increase the rate of restenosis in the stent in the later stage. For clinical CTO lesions, after the occluded segment is opened by simple guidewire or antegrade dissection re-entry (ADR) technology, for cases where the proximal and distal ends of the occlusion are in the true lumen, and the middle segment occlusion lesions are in the subintimal area, how to make this part of the subintimal false lumen also become the true lumen is an important prerequisite for ensuring the best treatment effect for CTO patients. At present, there is no medical device developed and used at home and abroad for penetrating the true and false lumens of the coronary artery.

[0003] The information in the background technology is only for illustrating the general background of the present invention and should not be regarded as admitting or suggesting in any form that such information constitutes the prior art known to a person skilled in the art. Summary of the invention

[0004] In order to solve at least some of the technical problems in the prior art, the present invention provides a cutting balloon. Specifically, the present invention includes the following contents.

[0005] According to a first aspect of the present invention, there is provided a cutting balloon, which comprises: a push rod, a balloon head, an inflation pipeline and a single-arm balloon connected to the head end; the balloon head end is fixedly arranged 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 arranged at the balloon head end; the inflation pipeline is arranged on the inner side of the push rod and is connected with the balloon head end and the single-arm balloon; the balloon head end is inflated through the inflation pipeline, and the balloon head end expands to push out the blade to perform a cutting action.

[0006] In certain embodiments, a unilateral arm balloon is disposed at the tip of the balloon near the blade; the unilateral arm balloon is connected to the tip of the balloon; when the inflation circuit does not inflate the tip of the balloon and the unilateral arm balloon, the unilateral arm balloon covers the blade; when the inflation circuit inflates the tip of the balloon and the unilateral arm balloon, the unilateral arm balloon expands and exposes the blade.

[0007] In certain embodiments, a balloon groove is disposed near the blade in the single-sided arm balloon, and the balloon groove is used to accommodate the blade when the single-sided arm balloon is not inflated.

[0008] In certain embodiments, when the unilateral arm balloon is inflated, the unilateral arm balloon gradually becomes thinner from the tail end to the tip end; wherein the portion where the unilateral arm balloon is 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 end of the unilateral arm balloon.

[0009] In certain embodiments, when the unilateral arm balloon is inflated, the outer diameter of the lumen of the unilateral arm balloon in the inflated state is designed according to the inner diameter of the true lumen.

[0010] In certain embodiments, the length of the blade is 1 mm or 1.2 mm.

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

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

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

[0014] In certain embodiments, a guidewire guiding cavity is further included, and the guidewire guiding cavity 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 the present invention solves the problem of the false lumen of the middle occluded section being located under the intima, so that the entire occluded section is the true lumen.

[0016] It should be understood that the above general description and the following detailed description are merely exemplary and illustrative and are not intended to limit the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The following drawings are a part of the specification of the present invention, and illustrate exemplary embodiments of the present invention. Together with the description of the specification, the accompanying drawings are used to explain the principles of the invention.

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

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

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

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

[0022] Description of reference numerals:

[0023] 1-push rod; 2-balloon head; 3-blade; 4-unilateral arm balloon; 5-balloon groove; 6-pressure pump inflation hole; 7-guidewire guiding cavity. DETAILED DESCRIPTION

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

[0025] It should be understood that the term in the present invention is only to describe a particular embodiment, not to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that the upper and lower limits of the scope and each intermediate value therebetween are specifically disclosed. Each smaller range between the intermediate value in any stated value or stated range and any other stated value or intermediate value in the range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0026] Unless otherwise specified, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which the invention belongs. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those herein may also be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail. Unless otherwise specified, "%" is a percentage based on weight.

[0027] The directional words appearing in the following description are all directions shown in the figures, and do not limit the specific structure of the embodiments of the present invention. In the description of the present invention, it should be noted that, unless otherwise specified, the terms "installation", "connection" and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0028] In addition, the terms "include", "comprise", "have" or any other variations thereof are intended to cover non-exclusive inclusion, so that a structure or component including a series of elements includes not only those elements, but also other mechanical elements that are not explicitly listed or inherent in the structure or component. In the absence of more restrictions, the elements defined by the sentence "include..." do not exclude the existence of other identical elements in the article or device including the elements.

[0029] Spatially related terms such as "below", "beneath", "under", "low", "above", "on", "high", etc. are used to facilitate description 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 orientations different from those shown in the figures. In addition, for example, "one element is above / below another element" can mean that the two elements are in direct contact, or that there are other elements between the two elements. In addition, terms such as "first", "second", etc. are also used to describe various elements, regions, parts, etc., and do not specifically refer to the meaning of order or sequence, and should not be regarded as limiting. Similar terms are used throughout the description to represent similar elements.

[0030] Example

[0031] like Figure 1 and 2 As shown, the present invention provides a cutting balloon, comprising: a push rod 1, a balloon head 2 and an inflation pipeline. The balloon head 2 is fixedly arranged at one end of the push rod 1, and the push rod 1 is used to adjust the position of the balloon head 2. The balloon head 2 is provided with a blade 3. The inflation pipeline is arranged inside the push rod 1 and is connected to the balloon head 2. The balloon head 2 is inflated through the inflation pipeline, and the balloon head 2 expands to push out the blade 3 to perform a cutting action on the inner membrane sheet of the true and false cavities.

[0032] In this embodiment, a push rod 1 is used to push the balloon tip 2 to the inner membrane sheet close to the true and false cavities, and the balloon tip 2 is inflated through the inflation pipeline (for example, the balloon tip 2 is inflated with a pressure of 12 atm), and the blade 3 provided at the balloon tip 2 is pushed out to penetrate the inner membrane sheets of the true and false cavities, and complete the cutting of the inner membrane of the true and false cavities, so that the false cavity segment becomes a full true cavity. The use of the cutting balloon to penetrate the true and false cavities of the coronary artery can open the occluded segment of the CTO patient, retain the side branch effect to the greatest extent, and expand the indications of the ADR technology. For example, the present application can be particularly suitable for scenarios where there are large branches of blood vessels (for example, Left anterior descending artery, LAD) in the occluded segment. In addition, the use of the cutting balloon to penetrate the true and false cavities of the coronary artery can further improve the CTO patency rate, reduce the operation time, the dose of radiation and contrast agent, and improve the patient's prognosis.

[0033] According to one embodiment of the present invention, a unilateral arm balloon 4 is provided near the blade 3 at the balloon head end 2. The unilateral arm balloon 4 is connected to the balloon head end 2. When the inflation pipeline does not inflate the balloon head end 2 and the unilateral arm balloon 4, the unilateral arm balloon 4 covers the blade 3. When the inflation pipeline inflates the balloon head end 2 and the unilateral arm balloon 4, the unilateral arm balloon 4 expands to expose the blade 3.

[0034] In this embodiment, the inflation pipeline, the balloon head end 2 and the unilateral arm balloon 4 can be an integrated structure that is connected. For example, when the inflation pipeline inflates the balloon head end 2 and the unilateral arm balloon 4, the unilateral arm balloon 4 expands to expose the blade 3, so that the blade 3 is located 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 of the unilateral arm balloon 4, and 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, the unilateral arm balloon 4 is arranged on the side of the balloon head end 2 close to the push rod 1, and the blade 3 is arranged between the unilateral arm balloon 4 and the push rod 1 (that is, the unilateral arm balloon is arranged at intervals from the push rod when it is in an expanded state). When the balloon head end 2 and the unilateral arm balloon 4 are not inflated and pressurized, the blade 3 is located in the balloon groove 5. The balloon head end 2 is pushed to the inner membrane sheet close to the true and false cavities by using the push rod 1, and the balloon head end 2 and the unilateral arm balloon 4 are inflated through the inflation pipeline. The balloon head end 2 separates the unilateral arm balloon 4 from the push rod 1 due to expansion, and pushes out the blade 3 hidden in the balloon groove 5. At this time, the unilateral arm balloon 4 in an expanded state is located in the true cavity, and the push rod 1 is pulled back. The inner membrane sheets of the true and false cavities are clamped between the push rod 1 and the unilateral arm balloon 4. The blade is located on the inner membrane sheets of the true and false cavities and cuts the inner membrane sheets located in the true and false cavities.

[0038] According to one embodiment of the present invention, when the unilateral arm balloon 4 is inflated, the unilateral arm balloon 4 gradually becomes thinner in the direction from the tail end to the tip end. The part where the unilateral arm balloon 4 is connected to the balloon head end 2 is the tail end of the unilateral arm balloon 4, and the part of the unilateral arm balloon 4 away from the balloon head end 2 is the tip end of the unilateral arm balloon 4. When the unilateral arm balloon 4 is inflated, the unilateral arm balloon 4 gradually becomes thinner in the direction from the tail end to the tip end.

[0039] In this embodiment, for example, the push rod 1 is used to push the balloon tip 2 to the inner membrane sheet close to the true and false lumens, and the balloon tip 2 and the unilateral arm balloon 4 are inflated through the inflation pipeline, and the tip of the unilateral arm balloon 4 faces the proximal end of the coronary blood vessel. The unilateral arm balloon 4 gradually becomes thinner from the tail end to the tip end, so that the unilateral arm balloon can pass through the true lumen compressed by the hematoma.

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

[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 the present embodiment, for example, the length of the blade 3 is 1 mm or 1.2 mm, which is only used to illustrate the length of the blade 3 and is not used to limit the protection scope of the present invention.

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

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

[0046] In this embodiment, for example, the balloon tip 2 may 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 direction, and the inflation pipeline is arranged in the hollow structure of the push rod 1 .

[0048] In this embodiment, for example, the push rod 1 may be a hollow structure. A pressure pump inflation hole 6 is provided at one end of the push rod 1, and the pressure pump inflation hole 6 is used to connect to an inflation device to inflate the balloon tip 2 (and the unilateral 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 an ordinary balloon, so as to facilitate the retraction of the blade 3 when the balloon is not inflated.

[0051] like Figure 1 and 2 As shown, according to one embodiment of the present invention, in addition to the push rod 1, the balloon tip 2 and the inflation pipeline, the cutting balloon further includes a guide wire guiding cavity 7, which is arranged 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 cavity 7 is used to guide the balloon tip 2 along the guidewire of the guidewire guiding cavity 7 into the corresponding blood vessel position to approach or move away from the inner membrane sheet of the true and false cavities. For example, after the balloon tip 2 enters the proximal true cavity, the negative pressure draws back the gas, so that the balloon groove 5 of the unilateral arm balloon 4 closes again to cover the blade 3 at the balloon tip 2, and at the same time, the balloon tip 2 and the unilateral arm balloon 4 retract to be closely attached to the push rod 1, and exit the body along the guiding catheter.

[0053] Although the present invention has been described with reference to exemplary embodiments, it should be understood that the present invention is not limited to the disclosed exemplary embodiments. Various adjustments or changes may be made to the exemplary embodiments of the present specification without departing from the scope or spirit of the present 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: A push rod, a balloon head and an inflation pipeline; the balloon head is fixedly arranged at one end of the push rod, and the push rod is used to adjust the position of the balloon head; a blade is arranged at the balloon head; The inflation pipeline is arranged inside the pushing rod and is connected with the balloon head end; the balloon head end is inflated through the inflation pipeline, and the balloon head end expands to push the blade out to perform the cutting action.

2. The cutting balloon according to claim 1, wherein a single-arm balloon is arranged at the tip of the balloon near the blade; the single-arm balloon is connected to the tip of the balloon; when the inflation pipeline does not inflate the tip of the balloon and the single-arm balloon, the single-arm balloon covers the blade; when the inflation pipeline inflates the tip of the balloon and the single-arm balloon, the tip of the balloon and the single-arm balloon expand and expose the blade.

3. The cutting balloon according to claim 2, wherein a balloon groove is provided in the single-sided arm balloon near the blade, and the balloon groove is used to accommodate the blade when the single-sided arm balloon is not inflated.

4. The cutting balloon according to claim 2, wherein when the single-sided arm balloon is inflated, the single-sided arm balloon gradually becomes thinner in the direction from the tail end to the tip end; wherein the portion where the single-sided arm balloon is connected to the balloon head end is the tail end of the single-sided arm balloon, and the portion of the single-sided arm balloon away from the balloon head end is the tip end of the single-sided arm balloon.

5. The cutting balloon according to claim 4, wherein the outer diameter of the lumen of the single-arm balloon in the inflated state is designed according to the true lumen inner diameter. 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 direction, and the inflation pipeline is arranged 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 further comprises a guidewire guiding cavity, wherein the guidewire guiding cavity is arranged 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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