Bead-type balloon structure for removing coronary interlayer hematoma through balloon withdrawing and use method of bead-type balloon structure

Abstract

The invention relates to a bead string type balloon structure for removing coronary artery interlayer hematoma through balloon withdrawing and a using method, the bead string type balloon structure comprises a connecting pipe and at least one balloon body, the balloon body is arranged on the connecting pipe, the balloon body is communicated with the connecting pipe, and the connecting pipe is connected with the connecting pipe. The balloon body comprises a first inclined part, a first contact part and a second inclined part, the right end of the first inclined part is connected with one end of the first contact part, and the other end of the first contact part is connected with the left end of the second inclined part; the first inclined part, the first contact part and the second inclined part form a protruding structure, and the section length of the first contact part in the extending direction of the connecting pipe is smaller than the preset size. Different from the prior art, the contact area between the balloon body and the endovascular intima is reduced, the withdrawing resistance is reduced, the contact between the balloon body and the endovascular intima is reduced, and excessive hyperplasia of the endovascular intima is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of coronary artery dissection hematoma removal, and in particular to a beaded balloon structure and a use method for balloon withdrawal to remove coronary artery dissection hematoma. Background Art

[0002] Coronary artery dissection with hematoma (CAD) is a potential complication of percutaneous coronary intervention (PCI). It occurs when a tear in the coronary artery intima causes blood to enter the interlaminar space of the vessel wall, forming a false lumen and accompanied by localized hematoma. Essentially, it is a complex lesion of intimal damage and intramural hemorrhage, which can lead to compression or occlusion of the true lumen, triggering myocardial ischemia and even acute myocardial infarction. CAD associated with PCI often results from direct intimal damage through procedures such as balloon or stent overexpansion, subintimal guidewire penetration, and atherectomy of calcified lesions, or from disruption of vessel wall integrity following the use of interventional devices (such as cutting balloons and shock wave balloons). CAD can be categorized as either localized (involving only a short segment of the vessel with minimal compression of the true lumen) or diffuse (involving the false lumen extending along the long axis of the vessel and potentially accompanied by distal thrombosis or complete occlusion).

[0003] Because coronary artery dissection hematomas can cause myocardial ischemia or even myocardial infarction, they require prompt treatment. Currently, the main targeted treatments for PCI-related coronary artery dissection hematomas are hematoma-targeted decompression and / or extended stent coverage. Targeted decompression primarily involves localized inflation of a cutting balloon. The blade on the cutting balloon's surface incises the intima above the hematoma, promoting blood drainage into the true lumen. However, this approach has a low success rate due to the following main reasons: 1. The vascular intima is actually tougher than imagined, making it virtually impossible for the cutting balloon's blade to incise the intima; 2. Because the hematoma between the intima and media is fluid, the intima's backside lacks a rigid surface to support it during inflation, causing it to expand and making it ineffective. Furthermore, repeated inflation of the cutting balloon can compress the hematoma and cause it to spread distally. Extended stent coverage, on the other hand, requires intravascular ultrasound to clearly define the distal hematoma site and then covers it with a stent at least 5 mm distal to the site to prevent it from spreading distally. However, implantation of a stent that is too long will lead to adverse consequences such as intra-stent thrombosis and intra-stent restenosis.

[0004] More information related to the above technical solutions can be found in the following documents:

[0005] Patent publication number CN221358140U discloses an angioplasty connecting tube, comprising: a connecting tube body, a guide head at the distal end of the connecting tube body, a pressure injection connector at the proximal end of the connecting tube body, the pressure injection connector having three independent pressure injection ports, and a composite balloon provided on the outer wall of the connecting tube body near the guide head; the composite balloon comprises a top balloon, a middle balloon and a terminal balloon arranged in sequence, the top balloon being close to the guide head, the middle balloon being close to the top balloon, and the terminal balloon being close to the middle balloon, the top balloon, the middle balloon and the terminal balloon being connected to a pressure injection port respectively; a non-ionic isotonic contrast agent is injected into the top balloon, the middle balloon and the terminal balloon by a pressure injection pump to inflate the top balloon, the middle balloon and the terminal balloon, so that the stent steel beam suspended in the aorta can be 360° close to the aortic wall, so that the stent at the opening can truly achieve proximal optimization.

[0006] In the process of implementing the present invention, the inventors found that the prior art has the following problems:

[0007] The cross-sectional length of the contact surface of the existing balloon body is 10mm-15mm, which increases the contact area between the balloon body and the vascular endothelium, making the withdrawal resistance larger. In addition, excessive contact between the balloon body and the vascular endothelium will stimulate the vascular endothelium and cause it to over-proliferate. Summary of the Invention

[0008] To this end, it is necessary to provide a beaded balloon structure and a method of use for balloon withdrawal to clear coronary artery dissection hematoma, so as to solve the technical problems that the cross-sectional length of the contact surface of the existing balloon body is 10mm-15mm, which increases the contact area between the balloon body and the vascular endothelium, making the withdrawal resistance larger, and excessive contact between the balloon body and the vascular endothelium will stimulate the vascular endothelium and cause its excessive proliferation.

[0009] To achieve the above objectives, in a first aspect, the present invention provides a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma, comprising:

[0010] connecting pipes; and

[0011] At least one balloon body, the balloon body is arranged on the connecting tube, the balloon body is connected to the connecting tube, the balloon body includes a first inclined portion, a first contact portion and a second inclined portion, the right end of the first inclined portion is connected to one end of the first contact portion, the other end of the first contact portion is connected to the left end of the second inclined portion, the first inclined portion, the first contact portion and the second inclined portion form a protruding structure, the cross-sectional length of the first contact portion along the extension direction of the connecting tube is smaller than a preset size, and a group of first inclined portions, first contact portions and second inclined portions are provided at the upper and lower ends of the connecting tube.

[0012] Different from the prior art, the above technical solution comprises a first inclined portion, a first contact portion and a second inclined portion through the balloon body, the right end of the first inclined portion is connected to one end of the first contact portion, the other end of the first contact portion is connected to the left end of the second inclined portion, the first inclined portion, the first contact portion and the second inclined portion form a convex structure, and the cross-sectional length of the first contact portion along the extension direction of the connecting tube is smaller than a preset size; in this way, the first inclined portion, the first contact portion and the second inclined portion form a convex structure, the top of the convex structure is the first contact portion, and the balloon The balloon body contacts the coronary artery dissection hematoma through the first contact part, and the cross-sectional length of the first contact part is smaller than the preset size, thereby reducing the contact area between the balloon body and the vascular endothelium; during use, the balloon body is sent to the distal end of the coronary artery dissection hematoma, the balloon body is inflated, and the inflated balloon body is withdrawn toward the proximal end of the coronary artery dissection hematoma, and the coronary artery dissection hematoma is squeezed through the first contact part. By repeated withdrawal and squeezing, the coronary artery dissection hematoma is cleared; the contact area between the balloon body and the vascular endothelium is reduced, the withdrawal resistance is reduced, the contact between the balloon body and the vascular endothelium is reduced, and excessive proliferation of the vascular endothelium is avoided.

[0013] As an embodiment of the present invention, the beaded balloon structure includes two or more balloon bodies, the two or more balloon bodies are arranged along the extension direction of the connecting tube, and the two or more balloon bodies are connected to each other.

[0014] In this way, during use, two or more balloon bodies can squeeze the coronary artery dissection hematoma more than twice, thereby improving the efficiency of the beaded balloon structure in clearing the coronary artery dissection hematoma.

[0015] As an embodiment of the present invention, the maximum diameters of two adjacent balloon bodies are the same.

[0016] In this way, by making the maximum diameters of the two adjacent balloon bodies the same, the coronary artery dissection hematoma can be squeezed twice with the same size, thereby improving the removal effect of the coronary artery dissection hematoma.

[0017] As an embodiment of the present invention, the cross-sectional lengths of the first contact portions of two adjacent balloon bodies in the extending direction of the connecting tube are the same.

[0018] In this way, the contact area of the first contact portions of two adjacent balloon bodies is smaller than the preset size, and the contact area of the first contact portions of two adjacent balloon bodies is the same, which reduces the contact area between the balloon body and the vascular endothelium and reduces the withdrawal resistance.

[0019] As an embodiment of the present invention, the beaded balloon structure includes three balloon bodies, which are arranged along the extension direction of the connecting tube, are interconnected, and have the same maximum diameter.

[0020] In this way, the three balloon bodies can be used to continuously squeeze the coronary artery dissection hematoma three times of equal size, thereby improving the removal efficiency and effect of the coronary artery dissection hematoma.

[0021] As an embodiment of the present invention, the first inclined portion and the second inclined portion are arc-shaped structures, the first inclined portion convexly projects away from the center of the balloon body, and the second inclined portion is concave toward the center line of the connecting tube.

[0022] In this way, the first inclined portion protrudes toward the direction away from the center of the balloon body, and the second inclined portion is recessed toward the center line of the connecting tube. A tip structure is formed on the right side of the second inclined portion of the balloon body, which makes it easier for the balloon body to squeeze the coronary dissection hematoma and insert between the coronary dissection hematomas when it is retracted; a supporting structure is formed on the left side of the first inclined portion of the balloon body to push the first contact portion upward and provide support for the first contact portion.

[0023] As an embodiment of the present invention, the connecting tube has a distal end and a proximal end, the first inclined portion is arranged relative to the distal end, the second inclined portion is arranged relative to the proximal end, and the second inclined portion extends in a direction close to the proximal end.

[0024] In this way, during use, the balloon body is sent to the distal end of the coronary artery dissection hematoma, the balloon body is inflated, and the inflated balloon body is retracted toward the proximal end of the coronary artery dissection hematoma. The second inclined portion forms a tip structure and is inserted between the coronary artery dissection hematoma. The first contact portion squeezes the coronary artery dissection hematoma, and the second inclined portion supports the first contact portion, making it easier for the balloon body to squeeze the coronary artery dissection hematoma and reduce the retraction resistance.

[0025] As an embodiment of the present invention, the first inclined portion protrudes toward a direction away from the center of the balloon body, and the second inclined portion is symmetrically arranged with the first inclined portion, and the second inclined portion protrudes toward a direction away from the center of the balloon body.

[0026] In this way, the first inclined portion protrudes toward a direction away from the center of the balloon body, and the second inclined portion is symmetrically arranged with the first inclined portion, which facilitates processing of the balloon body.

[0027] As an embodiment of the present invention, the cross-sectional length of the first contact portion in the extending direction of the connecting tube is 0.8 mm to 1.2 mm.

[0028] In this way, the cross-sectional length of the contact surface of the existing balloon body is 10mm-15mm, and the cross-sectional length of the first contact part of the present application is 0.8mm~1.2mm, which greatly reduces the contact area between the balloon body and the vascular endothelium, reduces the withdrawal resistance, avoids excessive contact between the balloon body and the vascular endothelium, and avoids excessive proliferation of the vascular endothelium.

[0029] To achieve the above objectives, in a second aspect, the inventors provide a method for using a beaded balloon structure for balloon withdrawal to remove a coronary artery dissection hematoma, comprising any of the above-mentioned beaded balloon structures for balloon withdrawal to remove a coronary artery dissection hematoma, comprising the following steps:

[0030] Select a balloon body with a diameter smaller than that of the distal artery;

[0031] The balloon body is delivered to the distal end of the coronary artery dissection hematoma along the extending direction of the guidewire to inflate the balloon body;

[0032] The inflated balloon body is withdrawn toward the proximal end of the coronary artery dissection hematoma and the coronary artery dissection hematoma is squeezed;

[0033] Repeat the above steps until the coronary artery dissection hematoma is cleared.

[0034] Different from the existing technology, the method of using the technical solution of the present application uses a balloon body that is 0.5-1mm smaller than the diameter of the blood vessel, sends it to the distal end of the coronary dissection hematoma along the guide wire, inflates the balloon, and slowly withdraws it. This method can effectively drive the hematoma back to the proximal end of the blood vessel and discharge it from the entrance of the dissection. The effect of restoring coronary blood flow is far better than the cutting balloon hematoma decompression technology; the balloon body contacts the coronary dissection hematoma through the first contact part, and the cross-sectional length of the first contact part is smaller than the preset size, reducing the contact area between the balloon body and the vascular endothelium; reducing the contact area between the balloon body and the vascular endothelium, reducing the withdrawal resistance, reducing the contact between the balloon body and the vascular endothelium, and avoiding excessive proliferation of the vascular endothelium.

[0035] The above-mentioned records related to the content of the invention are only an overview of the technical solution of this application. In order to enable ordinary technicians in this field to understand the technical solution of this application more clearly, and then implement it according to the text of the specification and the contents recorded in the drawings, and to make the above-mentioned purposes and other purposes, features and advantages of this application easier to understand, the following is an explanation in combination with the specific implementation methods and drawings of this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings are only used to illustrate the principles, implementation methods, applications, characteristics and effects of the specific embodiments of this application and other related contents, and are not to be considered as limiting this application.

[0037] In the drawings of the specification:

[0038] Figure 1 This is a schematic structural diagram of the existing balloon body of this application;

[0039] Figure 2 This is a schematic structural diagram of a beaded balloon structure according to one embodiment of the present application;

[0040] Figure 3 This is a schematic structural diagram of a beaded balloon structure according to another embodiment of the present application;

[0041] Figure 4 This is a schematic structural diagram of a beaded balloon structure according to another embodiment of the present application;

[0042] Figure 5 This is a schematic diagram of the use process of a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma according to one embodiment of the present application;

[0043] Figure 6 This is an example of a case for this application Figure 1 ;

[0044] Figure 7 This is an example of a case for this application Figure 2 ;

[0045] Figure 8 This is an example of a case for this application Figure 3 ;

[0046] Figure 9 This is an example of a case for this application Figure 4 ;

[0047] The reference numerals in the above drawings are described as follows:

[0048] A. the contact surface of the existing balloon body, a. the contact surface of the balloon body of the present application;

[0049] b. The maximum diameter of the balloon body;

[0050] c. The center direction of the balloon body, d. The center line direction of the connecting tube;

[0051] 1. Connecting pipe,

[0052] 2. Balloon body, 21. First inclined portion, 22. First contact portion, 23. Second inclined portion,

[0053] 3. Coronary artery dissection hematoma. DETAILED DESCRIPTION

[0054] In order to explain in detail the possible application scenarios, technical principles, specific solutions that can be implemented, and the purpose and effects of this application, the following is a detailed description of the specific embodiments listed in conjunction with the accompanying drawings. The embodiments described herein are only used to more clearly illustrate the technical solutions of this application and are therefore only examples and are not intended to limit the scope of protection of this application.

[0055] References to "embodiments" herein mean that the specific features, structures, or characteristics described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the word "embodiment" in various places in the specification does not necessarily refer to the same embodiment, nor does it particularly limit its independence or relevance to other embodiments. In principle, in this application, as long as there are no technical contradictions or conflicts, the various technical features mentioned in the embodiments can be combined in any manner to form a corresponding implementable technical solution.

[0056] Unless otherwise defined, the technical terms used herein have the same meanings as those generally understood by those skilled in the art to which this application belongs; the use of relevant terms herein is only for describing specific embodiments and is not intended to limit this application.

[0057] In the description of this application, the term "and / or" is used to describe a logical relationship between objects, indicating that three possible relationships exist. For example, the beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma and / or B indicates the presence of the beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma, the presence of B, and the simultaneous presence of the beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma and B. Furthermore, the character " / " herein generally indicates that the related objects are in an "or" logical relationship.

[0058] In this application, terms such as "first" and "second" are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual quantity, priority or sequence relationship between these entities or operations.

[0059] Without further limitations, in this application, the words "include", "comprise", "have" or other similar open-ended expressions used in sentences are intended to cover non-exclusive inclusion. These expressions do not exclude the presence of additional elements in the process, method or product that includes the elements, so that the process, method or product that includes a series of elements may include not only those defined elements, but also other elements that are not explicitly listed, or also include elements inherent to such process, method or product.

[0060] Consistent with the understanding in the Examination Guidelines, in this application, expressions such as "greater than," "less than," and "exceed" are understood to exclude the number itself; expressions such as "above," "below," and "within" are understood to include the number itself. Furthermore, in the description of the embodiments of this application, "multiple" means more than two (including two), and similar expressions related to "multiple" are also understood in this manner, such as "multiple groups," "multiple times," etc., unless otherwise specifically defined.

[0061] In the description of the embodiments of the present application, the space-related expressions used, such as "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "vertical", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicate the orientation or position relationship based on the orientation or position relationship shown in the specific embodiments or drawings, and are only for the convenience of describing the specific embodiments of the present application or facilitating the reader's understanding, and do not indicate or imply that the device or component referred to must have a specific position, a specific orientation, or be constructed or operated in a specific orientation. Therefore, it should not be understood as a limitation on the embodiments of the present application.

[0062] Unless otherwise expressly specified or limited, in the description of the embodiments of the present application, the terms "installed", "connected", "connected", "fixed", "set", etc. used should be understood in a broad sense. For example, the "connection" can be a fixed connection, a detachable connection, or an integrated setting; it can be a direct connection, or an indirect connection through an intermediate medium; it can be a relationship in which two components are combined together, or an interaction relationship between two components, or a communication between two structures. For those skilled in the art of the present application, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0063] Existing technologies for targeted hematoma decompression primarily utilize a cutting balloon for localized expansion, using the blade on the balloon's surface to incise the endothelium on the surface of the hematoma, promoting blood drainage into the true lumen. However, this method has a very low success rate. Extended stent coverage, on the other hand, requires intravascular ultrasound to clearly define the distal end of the hematoma and then covers it with a stent extending at least 5 mm beyond the distal end to prevent it from spreading. However, implanting an excessively long stent can lead to adverse consequences such as in-stent thrombosis and in-stent restenosis.

[0064] To address the aforementioned clinical issues, the inventors have developed a small balloon low-pressure withdrawal technique (SBLP). This technique uses a balloon 0.5-1 mm smaller than the vessel diameter (e.g., if the vessel diameter of the hematoma is 2.5 mm, a 2.0 or 1.5 mm balloon is used). This balloon is delivered along a guidewire to the distal end of the hematoma, inflated, and slowly withdrawn. This method effectively drives the hematoma back to the proximal end of the vessel and out of the dissection entrance, restoring coronary blood flow far more effectively than the cutting balloon hematoma decompression technique.

[0065] However, the cross-sectional length of the contact surface of the existing balloon body is 10mm-15mm, which increases the contact area between the balloon body and the vascular endothelium, making the withdrawal resistance larger. In addition, excessive contact between the balloon body and the vascular endothelium will stimulate the vascular endothelium and cause it to over-proliferate.

[0066] Therefore, it is urgent to invent a new type of balloon structure specifically for small balloon low pressure withdrawal technology (SBLP technology).

[0067] In view of this, an embodiment of the present application provides a beaded balloon structure for balloon withdrawal to remove a coronary dissection hematoma 3, comprising a connecting tube 1 and at least one balloon body 2. The balloon body 2 is disposed on the connecting tube 1 and is in communication with the connecting tube 1. The balloon body 2 comprises a first inclined portion 21, a first contact portion 22, and a second inclined portion 23. The right end of the first inclined portion 21 is connected to one end of the first contact portion 22, and the other end of the first contact portion 22 is connected to the left end of the second inclined portion 23. The first inclined portion 21, the first contact portion 22, and the second inclined portion 23 form a raised structure. The cross-sectional length of the first contact portion 22 along the extension direction of the connecting tube 1 is less than a preset size. In this way, the contact area between the balloon body 2 and the vascular endothelium is reduced, the withdrawal resistance is reduced, the contact between the balloon body 2 and the vascular endothelium is reduced, and excessive vascular endothelial hyperplasia is avoided.

[0068] See also Figures 1 to 9 The present embodiment relates to a beaded balloon structure for balloon withdrawal to remove coronary dissection hematoma 3, including a connecting tube 1 and at least one balloon body 2; the balloon body 2 is arranged on the connecting tube 1, and the balloon body 2 is connected to the connecting tube 1. The balloon body 2 includes a first inclined portion 21, a first contact portion 22 and a second inclined portion 23. The right end of the first inclined portion 21 is connected to one end of the first contact portion 22, and the other end of the first contact portion 22 is connected to the left end of the second inclined portion 23. The first inclined portion 21, the first contact portion 22 and the second inclined portion 23 form a convex structure. The cross-sectional length of the first contact portion 22 along the extension direction of the connecting tube 1 is less than the preset size. A group of first inclined portions 21, first contact portions 22 and second inclined portions 23 are provided at the upper and lower ends of the connecting tube 1.

[0069] like Figure 1As shown, the existing balloon body 2 is an elliptical shape that is flattened along the extension direction of the blood vessel. The contact surface A of the existing balloon body is relatively large. The bottom surface and the top surface of the balloon body 2 are the contact surfaces. The cross-sectional length of the contact surface of the balloon body 2 is 10mm-15mm.

[0070] like Figure 2 As shown, the improved balloon body 2 is a flat structure along the width direction of the blood vessel. The flat structure is changed to a structure with a pointed top and bottom surface. The contact surface a of the balloon body of the present application is small. The bottom and top surfaces of the balloon body 2 are the contact surfaces. The cross-sectional length of the contact surface of the balloon body 2 is 0.8 mm-1.2 mm, which is about one tenth of the cross-sectional length of the contact surface of the balloon body 2 before the improvement. In this way, the contact area between the balloon body 2 and the vascular endothelium is greatly reduced, which can reduce the withdrawal resistance and effectively drive the hematoma back to the proximal end of the blood vessel and discharge it from the entrance of the dissection.

[0071] The principle of the balloon body 2 is the same as that of the rapid exchange balloon. It can be inserted into the interlayer blood tube along the guide wire and expanded by injecting gas or liquid. The specific principle is a conventional technical means and will not be repeated here.

[0072] The maximum diameter of the balloon body 2 is about 0.5mm-1mm smaller than the inner diameter of the blood vessel. For example, if the inner diameter of the blood vessel where the hematoma occurs is 2.5mm, a 2.0mm or 1.5mm balloon body 2 is used;

[0073] The method of using the beaded balloon structure is to select a balloon body 2 that is 0.5 mm smaller than the target blood vessel diameter, send the balloon into the distal end of the coronary hematoma along the guide wire, expand it at 4-6 atm and slowly withdraw it, and repeat 2-3 times to effectively restore blood flow.

[0074] Different from the prior art, the above technical solution comprises a first inclined portion 21, a first contact portion 22 and a second inclined portion 23 through the balloon body 2, wherein the right end of the first inclined portion 21 is connected to one end of the first contact portion 22, and the other end of the first contact portion 22 is connected to the left end of the second inclined portion 23. The first inclined portion 21, the first contact portion 22 and the second inclined portion 23 form a convex structure, and the cross-sectional length of the first contact portion 22 along the extension direction of the connecting tube 1 is smaller than a preset size;

[0075] In this way, the first inclined portion 21, the first contact portion 22 and the second inclined portion 23 form a raised structure, the top of the raised structure is the first contact portion 22, and the balloon body 2 contacts the coronary dissection hematoma 3 through the first contact portion 22. The cross-sectional length of the first contact portion 22 is smaller than the preset size, reducing the contact area between the balloon body 2 and the vascular endothelium; during use, the balloon body 2 is sent to the distal end of the coronary dissection hematoma 3, the balloon body 2 is inflated, and the inflated balloon body 2 is retracted toward the proximal end of the coronary dissection hematoma 3, and the coronary dissection hematoma 3 is squeezed through the first contact portion 22. By repeated retraction and squeezing, the coronary dissection hematoma 3 is removed; the contact area between the balloon body 2 and the vascular endothelium is reduced, the retraction resistance is reduced, the contact between the balloon body 2 and the vascular endothelium is reduced, and excessive proliferation of the vascular endothelium is avoided.

[0076] According to some embodiments of the present application, optionally, the beaded balloon structure includes more than two balloon bodies 2, and the two or more balloon bodies 2 are arranged along the extension direction of the connecting tube 1, and the two or more balloon bodies 2 are connected to each other.

[0077] like Figure 3 As shown, in some embodiments, the beaded balloon structure comprises two balloon bodies 2, which are arranged along the direction of the blood vessel, and one withdrawal can squeeze the coronary artery dissection hematoma 3 twice;

[0078] In this way, during use, two or more balloon bodies 2 can squeeze the coronary artery dissection hematoma 3 more than twice, thereby improving the efficiency of the beaded balloon structure in clearing the coronary artery dissection hematoma 3.

[0079] According to some embodiments of the present application, optionally, the maximum diameters of two adjacent balloon bodies 2 are the same.

[0080] like Figure 3 As shown, the maximum diameter b of the two balloon bodies 2 is the same, the shape and structure of the two balloon bodies 2 are the same, and of course the cross-sectional lengths of the first contact portions 22 of the two balloon bodies 2 in the extending direction of the connecting tube 1 are the same;

[0081] In this way, by making the maximum diameters of two adjacent balloon bodies 2 the same, the coronary artery dissection hematoma 3 can be squeezed twice with the same size, thereby improving the removal effect of the coronary artery dissection hematoma 3.

[0082] According to some embodiments of the present application, optionally, the cross-sectional lengths of the first contact portions 22 of two adjacent balloon bodies 2 in the extension direction of the connecting tube 1 are the same.

[0083] In this way, the contact area of the first contact portions 22 of two adjacent balloon bodies 2 is smaller than the preset size, and the contact area of the first contact portions 22 of two adjacent balloon bodies 2 is the same, which reduces the contact area between the balloon body 2 and the vascular endothelium and reduces the withdrawal resistance.

[0084] According to some embodiments of the present application, optionally, the beaded balloon structure includes three balloon bodies 2, the three balloon bodies 2 are arranged along the extension direction of the connecting tube 1, the three balloon bodies 2 are interconnected, and the maximum diameters of the three balloon bodies 2 are the same.

[0085] like Figure 3 As shown, in some embodiments, the beaded balloon structure comprises three balloon bodies 2, which are arranged along the direction of the blood vessel. One withdrawal can squeeze the coronary artery dissection hematoma 3 three times.

[0086] The maximum diameter b of the three balloon bodies 2 is the same, and the shape and structure of the three balloon bodies 2 are the same. Of course, the cross-sectional lengths of the first contact portions 22 of the three balloon bodies 2 in the extending direction of the connecting tube 1 are the same;

[0087] In this way, the three balloon bodies 2 can be used to continuously squeeze the coronary artery dissection hematoma 3 three times of equal size, thereby improving the removal efficiency and effect of the coronary artery dissection hematoma 3.

[0088] According to some embodiments of the present application, optionally, the first inclined portion 21 and the second inclined portion 23 are arc-shaped structures, the first inclined portion 21 bulges toward the direction away from the center of the balloon body 2, and the second inclined portion 23 is recessed toward the center line of the connecting tube 1.

[0089] like Figure 2 As shown, the first inclined portion 21 bulges outwardly toward the center direction of the balloon body as indicated by arrow c, and the second inclined portion 23 is recessed inwardly toward the center line direction of the connecting tube as indicated by arrow d. During use, the balloon body 2 is squeezed from the distal end of the blood vessel to the proximal end of the blood vessel, and the hematoma can be discharged from the entrance of the vascular dissection. At this time, the second inclined portion 23 is relatively sharp, making it easier to enter between the upper and lower hematomas of the blood vessel, while the first inclined portion 21 is relatively round, making it easier to support the first contact portion 22.

[0090] In this way, the first inclined portion 21 protrudes toward the center direction away from the balloon body 2, and the second inclined portion 23 is recessed toward the center line direction close to the connecting tube 1. A tip structure is formed at the right side of the second inclined portion 23 of the balloon body 2, which makes it more convenient for the balloon body 2 to squeeze the coronary dissection hematoma 3 and insert between the coronary dissection hematomas 3 when it is retracted; a supporting structure is formed at the left side of the first inclined portion 21 of the balloon body 2, which pushes the first contact portion 22 upward and supports the first contact portion 22.

[0091] According to some embodiments of the present application, optionally, the connecting tube 1 has a distal end and a proximal end, the first inclined portion 21 is arranged relative to the distal end, the second inclined portion 23 is arranged relative to the proximal end, and the second inclined portion 23 extends in a direction close to the proximal end.

[0092] In this way, during use, the balloon body 2 is sent to the distal end of the coronary dissection hematoma 3, the balloon body 2 is expanded, and the expanded balloon body 2 is retracted toward the proximal end of the coronary dissection hematoma 3. The second inclined portion 23 forms a tip structure and is inserted between the coronary dissection hematoma 3. The first contact portion 22 squeezes the coronary dissection hematoma 3, and the second inclined portion 23 supports the first contact portion 22, which facilitates the balloon body 2 to squeeze the coronary dissection hematoma 3 and reduce the retraction resistance.

[0093] According to some embodiments of the present application, optionally, the first inclined portion 21 protrudes toward a direction away from the center of the balloon body 2, and the second inclined portion 23 is symmetrically arranged with the first inclined portion 21, and the second inclined portion 23 protrudes toward a direction away from the center of the balloon body 2.

[0094] like Figure 3 and Figure 4 As shown, the first inclined portion 21 bulges outwardly toward the center direction arrow c of the balloon body, and the second inclined portion 23 bulges outwardly toward the center direction arrow c of the balloon body, forming a symmetrical structure, which facilitates the production of the balloon body 2, improves production efficiency, and reduces defective rate;

[0095] In this way, the first inclined portion 21 protrudes toward a direction away from the center of the balloon body 2 , and the second inclined portion 23 is symmetrically arranged with the first inclined portion 21 , which facilitates processing of the balloon body 2 .

[0096] According to some embodiments of the present application, optionally, a cross-sectional length of the first contact portion 22 in the extension direction of the connecting tube 1 is 0.8 mm to 1.2 mm.

[0097] In this way, the cross-sectional length of the contact surface of the existing balloon body 2 is 10mm-15mm, and the cross-sectional length of the first contact portion 22 of the present application is 0.8mm~1.2mm, which greatly reduces the contact area between the balloon body 2 and the vascular endothelium, reduces the withdrawal resistance, avoids excessive contact between the balloon body 2 and the vascular endothelium, and avoids excessive proliferation of the vascular endothelium.

[0098] In a second aspect, this embodiment further relates to a method for using a beaded balloon structure for balloon withdrawal to remove a coronary artery dissection hematoma, including any of the above-mentioned beaded balloon structures for balloon withdrawal to remove a coronary artery dissection hematoma, comprising the following steps:

[0099] Selecting a balloon body 2 with a diameter smaller than that of the distal artery;

[0100] The balloon body 2 is delivered to the distal end of the coronary artery dissection hematoma 3 along the extending direction of the guidewire to inflate the balloon body 2;

[0101] withdrawing the inflated balloon body 2 toward the proximal end of the coronary artery dissection hematoma 3 and squeezing the coronary artery dissection hematoma 3;

[0102] Repeat the above steps until the coronary artery dissection hematoma is cleared3.

[0103] like Figure 5 As shown, before the balloon is withdrawn to clear the coronary artery dissection hematoma, an outlet needs to be opened at one end of the coronary artery dissection hematoma 3 (the proximal end of the coronary artery dissection hematoma 3), and the balloon body 2 is sent into the distal end of the coronary artery dissection hematoma 3 (the right end in the figure) along the extension direction of the guide wire to expand the balloon body 2; the expanded balloon body 2 is withdrawn to the proximal end of the coronary artery dissection hematoma 3 (the left end in the figure), and the coronary artery dissection hematoma 3 is squeezed; the liquid in the coronary artery dissection hematoma 3 can be squeezed out, and the coronary artery dissection hematoma 3 in the blood vessel can be cleared.

[0104] Different from the existing technology, the method of using the technical solution of the present application uses a balloon body 2 that is 0.5-1mm smaller than the diameter of the blood vessel, sends it to the distal end of the coronary dissection hematoma 3 along the guide wire, inflates the balloon, and slowly withdraws it. This method can effectively drive the hematoma back to the proximal end of the blood vessel and discharge it from the entrance of the dissection. The effect of restoring coronary blood flow is far better than the cutting balloon hematoma decompression technology; the balloon body 2 contacts the coronary dissection hematoma 3 through the first contact part 22, and the cross-sectional length of the first contact part 22 is smaller than the preset size, reducing the contact area between the balloon body 2 and the vascular endothelium; reducing the contact area between the balloon body 2 and the vascular endothelium, reducing the withdrawal resistance, reducing the contact between the balloon body 2 and the vascular endothelium, and avoiding excessive proliferation of the vascular endothelium.

[0105] like Figures 6 to 9 As shown, this application provides the successful application of a small balloon low-pressure withdrawal technique in four patients who developed CIMH during PCI. The efficacy of the procedure was assessed using the Thrombolysis in Myocardial Infarction (TIMI) blood flow grading system, and all four patients achieved TIMI grade III blood flow after surgery, indicating complete restoration of distal blood flow. The results of this study demonstrate that the small balloon low-pressure withdrawal technique is a promising minimally invasive treatment for CIMH, restoring blood flow while minimizing the risk of iatrogenic injury.

[0106] Patient 1: A 45-year-old woman presented with chest pain. Laboratory tests revealed elevated troponin T levels, and coronary angiography revealed 80% stenosis of the distal left main coronary artery (LM). Figure 6 A). Therefore, we attempted a left anterior descending artery (LAD)-LM crossover PCI. After treatment of the LM artery lesion with a 2.5 mm Wolverine cutting balloon (Boston Scientific), angiography revealed new stenosis of the LAD artery ( Figure 6B). Intravascular ultrasound (IVUS) confirmed that CIMH extended from the distal LM to the mid-LAD ( Figure 6 C). Poor LAD blood flow due to hematoma ( Figure 6 D). We then used a 2.5 mm cutting balloon to drain the CIMH ( Figure 6 E), but failed to improve blood flow. Finally, we performed the small balloon low pressure withdrawal technique (SBLP): a 2.0 mm balloon was inflated at 2 atm and then pulled back into the guiding catheter ( Figure 6 F). Angiography showed TIMI III blood flow ( Figure 6 GH).

[0107] Patient 2: A 62-year-old male presented with chest pain. Coronary angiography revealed chronic total occlusion (CTO) of the mid-LAD and subtotal occlusion of the posterolateral artery (PLA), with distal TIMI grade 1 flow ( Figure 7 A). After implantation of a 2.5*23mm stent, distal blood flow deteriorated, which was considered to be CIMH caused by stent implantation ( Figure 7 C). We performed small balloon low pressure withdrawal (SBLP) using a 2.0 mm balloon inflated at 2 atmospheres and retracted the guide catheter ( Figure 7 D), restore distal TIMI grade 3 blood flow ( Figure 7 E).

[0108] Patient 3: A 77-year-old male was admitted to the hospital with chest pain and anterior Q waves on electrocardiogram. Coronary angiography showed a CTO in the mid-LAD segment ( Figure 8 A), PCI of the CTO of the LAD was planned. Multiple guidewires were used, such as Runthrough, Field XTR, and GAIA, and finally the distal end of the Pilot 150 (Abbott) was inserted into the true lumen ( Figure 8 C). IVUS showed diffuse CIMH with TIMI grade 1 flow caused by the forward guidewire technique ( Figure 8 D). Afterwards, the 2.0 mm balloon was inflated at 2 atm and the guide catheter was pulled back ( Figure 8 E), immediately resolved CIMH ( Figure 8 F). After implantation of three stents, the operation was completed and the final TIMI grade 3 blood flow ( Figure 8 G).

[0109] Patient 4: A 48-year-old male presented with typical angina pectoris on exertion. Angiography showed severe stenosis of the LAD artery ( Figure 9 A). We attempted to perform PCI of the LAD artery to improve angina. Angiography showed diffuse LAD artery dissection and CIMH, so balloon and diagonal branch dilation was performed, resulting in poor distal blood flow ( Figure 9B). After IVUS confirmed diffuse LAD artery dissection and CIMH, we implanted 5 stents in the LAD artery under IVUS guidance, and LAD blood flow immediately recovered to TIMI grade 3. However, due to CIMH, the diagonal branch blood flow remained TIMI grade 1 ( Figure 9 C). We then used the small balloon low pressure withdrawal technique (SBLP): a 1.5 mm balloon was inflated at 4 atmospheres and then withdrawn from the distal end of the diagonal branch. After the small balloon low pressure withdrawal technique (SBLP), the TIMI III blood flow in the diagonal branch was ( Figure 9 DE).

[0110] Small balloon low-pressure evacuation (SBLP) represents a major advancement in the management of coronary intramural hematoma (CIMH). Unlike traditional approaches that may worsen the condition or fail to restore blood flow, SBLP is a minimally invasive procedure that effectively evacuates the hematoma while minimizing the risk of iatrogenic injury. In our case series, all four patients achieved Thrombolysis in Myocardial Infarction (TIMI) grade III blood flow after SBLP, regardless of the underlying mechanism of CIMH (post-stenting, post-balloon dilatation, or chronic total occlusion over-the-wire technique). This consistent success across a wide range of CIMH etiologies highlights the versatility and potential broad applicability of this technique.

[0111] The small balloon low-pressure retrieval (SBLP) technique offers several key advantages over traditional approaches. By gently compressing the hematoma proximally, the risk of distal hematoma expansion, a common complication of additional stent placement or cutting balloon angioplasty, is minimized. Furthermore, the SBLP technique rapidly restores coronary blood flow, thereby reducing the risk of myocardial ischemia and hemodynamic instability. This rapid resolution is crucial to preventing further complications associated with prolonged blood flow obstruction. Furthermore, the technique requires only conventional PCI equipment, making it a more cost-effective alternative to more complex interventions. This feature not only enhances its accessibility but also promotes its potential integration into routine clinical practice.

[0112] It should be noted that although the above embodiments have been described herein, this does not limit the scope of patent protection of the present invention. Therefore, based on the innovative concept of the present invention, changes and modifications to the embodiments described herein, or equivalent structural or equivalent process transformations made using the contents of the present invention's specification and drawings, and direct or indirect application of the above technical solutions to other related technical fields, are all included in the scope of patent protection of the present invention.

Claims

1. A beaded balloon structure for balloon retrieval to remove coronary artery dissection hematoma, characterized in that: include: connecting pipe; as well as At least one balloon body, the balloon body is arranged on the connecting tube, the balloon body is connected to the connecting tube, the balloon body includes a first inclined portion, a first contact portion and a second inclined portion, the right end of the first inclined portion is connected to one end of the first contact portion, the other end of the first contact portion is connected to the left end of the second inclined portion, the first inclined portion, the first contact portion and the second inclined portion form a protruding structure, the cross-sectional length of the first contact portion along the extension direction of the connecting tube is smaller than a preset size, and a group of first inclined portions, first contact portions and second inclined portions are provided at the upper and lower ends of the connecting tube.

2. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 1, characterized in that: The beaded balloon structure includes more than two balloon bodies, which are arranged along the extension direction of the connecting tube and are connected to each other.

3. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 2, characterized in that: The maximum diameters of two adjacent balloon bodies are the same.

4. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 3, characterized in that: The cross-sectional lengths of the first contact portions of two adjacent balloon bodies in the extending direction of the connecting tube are the same.

5. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 2, characterized in that: The beaded balloon structure includes three balloon bodies, which are arranged along the extension direction of the connecting tube, are interconnected, and have the same maximum diameter.

6. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 1, characterized in that: The first inclined portion and the second inclined portion are arc-shaped structures. The first inclined portion is convex toward a direction away from the center of the balloon body, and the second inclined portion is concave toward a direction close to the center line of the connecting tube.

7. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 6, characterized in that: The connecting tube has a distal end and a proximal end. The first inclined portion is arranged relative to the distal end, and the second inclined portion is arranged relative to the proximal end. The second inclined portion extends in a direction close to the proximal end.

8. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to claim 1, characterized in that: The first inclined portion protrudes in a direction away from the center of the balloon body, and the second inclined portion is symmetrically arranged with the first inclined portion, and the second inclined portion protrudes in a direction away from the center of the balloon body.

9. The beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to any one of claims 1 to 8, characterized in that: The cross-sectional length of the first contact portion in the extending direction of the connecting tube is 0.8 mm to 1.2 mm.

10. A method for using a beaded balloon structure for balloon retrieval to remove coronary artery dissection hematoma, characterized in that: A beaded balloon structure for balloon retrieval and removal of coronary artery dissection hematoma according to any one of claims 1 to 9, comprising the following steps: Select a balloon body with a diameter smaller than that of the distal artery; The balloon body is delivered to the distal end of the coronary artery dissection hematoma along the extending direction of the guidewire to inflate the balloon body; The inflated balloon body is withdrawn toward the proximal end of the coronary artery dissection hematoma and the coronary artery dissection hematoma is squeezed; Repeat the above steps until the coronary artery dissection hematoma is cleared.

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