String of beads balloon structure for balloon withdrawal to clear coronary dissection hematoma

Abstract

The utility model relates to a kind of string bead type balloon structure for balloon retraction to remove coronary dissection hematoma, including connecting pipe and at least one balloon body, the balloon body is arranged on the connecting pipe, the balloon body is connected with the connecting pipe, the balloon body includes first inclined part, first contact part and second inclined part, the right end of the first inclined part is connected with the one end of the first contact part, 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 convex structure, the cross-sectional length of the first contact part in the extension direction of the connecting pipe is less than preset size.Different from prior art, the utility model reduces the contact area of balloon body and vascular endothelium, reduces retraction resistance, reduces the contact of balloon body and vascular endothelium, avoids vascular endothelium excessive proliferation.

Description

Technical Field

[0001] This utility model relates to the field of coronary artery dissection hematoma evacuation technology, and in particular to a beaded balloon structure for balloon retraction to evacuate coronary artery dissection hematoma. Background Technology

[0002] Coronary artery dissection with hematoma is a possible complication during percutaneous coronary intervention (PCI). It occurs when the intima of a coronary artery tears, allowing blood to enter the vessel wall and form a false lumen, accompanied by a localized hematoma. Essentially, it is a complex lesion of intimal injury and intramural hemorrhage, which can lead to compression or occlusion of the true lumen, causing myocardial ischemia or even acute myocardial infarction. PCI-related coronary artery dissection with hematoma is often caused by direct damage to the intima due to procedures such as over-dilation of balloons or stents, guidewire penetration into the subintimal region, or rotational atherectomy of calcified lesions, or by disruption of vessel wall integrity after the use of interventional devices (such as cutting balloons and shockwave balloons). Coronary artery dissection with hematoma is classified into localized dissection hematoma (affecting only a short segment of the vessel with mild compression of the true lumen) and diffuse dissection hematoma (the false lumen extends along the long axis of the vessel and may be accompanied by distal thrombi or complete occlusion).

[0003] Because coronary artery dissection hematomas can lead to myocardial ischemia or even myocardial infarction, timely treatment is essential. Currently, the main targeted treatment methods for PCI-related coronary artery dissection hematomas are hematoma-targeted decompression and / or extended stent coverage techniques. Hematoma-targeted decompression primarily uses a cutting balloon for local dilation, employing a blade on the balloon's surface to cut the intima of the hematoma, promoting blood drainage into the true lumen. However, this method has a low success rate, mainly due to: 1. The vascular intima is actually tougher than imagined, and the blade on the cutting balloon's surface is essentially unable to cut through it; 2. Because the hematoma between the intima and media is fluid, there is no rigid surface support on the back of the intima when the cutting balloon dilates, causing the intima to expand and preventing the cutting balloon from effectively cutting. Furthermore, repeated dilation of the cutting balloon may cause the hematoma to be compressed and spread to the distal end of the vessel. Extended stent coverage, on the other hand, requires intravascular ultrasound to clearly identify the distal end of the hematoma and then using a stent extending at least 5mm beyond the distal end to cover the hematoma, preventing its spread to the distal end. However, implanting excessively long stents can lead to adverse consequences such as in-stent thrombosis and in-stent restenosis.

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

[0005] Patent publication number CN221358140U discloses a connecting tube for angioplasty, 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 on the outer wall of the connecting tube body near the guide head; the composite balloon includes a apical balloon, a mid-section balloon, and a terminal balloon arranged sequentially, with the apical balloon near the guide head, the mid-section balloon near the apical balloon, and the terminal balloon near the mid-section balloon, and each of the apical, mid-section, and terminal balloons connected to a pressure injection port; a non-ionic isotonic contrast agent is injected into the apical, mid-section, and terminal balloons by a pressure injection pump to inflate the apical, mid-section, and terminal balloons, so that the stent beam suspended in the aorta can fit tightly against the aortic wall at 360°, and the stent at the opening is truly optimized proximally.

[0006] In the process of realizing this utility model, the inventors discovered the following problems in the prior art:

[0007] The existing balloon body has a contact surface with a cross-sectional length of 10mm-15mm, which increases the contact area between the balloon body and the vascular intima, resulting in greater retraction resistance. Furthermore, excessive contact between the balloon body and the vascular intima can stimulate the vascular intima, leading to its excessive proliferation. Utility Model Content

[0008] Therefore, there is a need to provide a beaded balloon structure and usage method for balloon retraction to clear coronary artery dissection hematoma, in order to solve the technical problems of the existing balloon body having a contact surface length of 10mm-15mm, which increases the contact area between the balloon body and the vascular intima, resulting in greater retraction resistance, and excessive contact between the balloon body and the vascular intima, which can stimulate the vascular intima and lead to its excessive proliferation.

[0009] To achieve the above objectives, in a first aspect, this utility model provides a beaded balloon structure for balloon withdrawal to clear coronary artery dissection hematoma, comprising:

[0010] Connecting pipe; and

[0011] At least one balloon body is disposed on the connecting tube and 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, and 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 less than a preset size. A set of first inclined portions, first contact portions, and second inclined portions are provided at both the upper and lower ends of the connecting tube.

[0012] Unlike existing technologies, the above technical solution uses a balloon body comprising 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, and 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 less than a preset size. Thus, the first inclined portion, the first contact portion, and the second inclined portion form a protruding structure, with the top of the protruding structure being the first contact portion. The balloon body contacts the coronary artery dissection hematoma through the first contact portion. The cross-sectional length of the first contact portion is smaller than the preset size, reducing the contact area between the balloon body and the vascular intima. During use, the balloon body is inserted into the distal end of the coronary artery dissection hematoma, inflated, and then withdrawn towards the proximal end of the hematoma. The first contact portion is used to compress the hematoma, and through repeated withdrawal and compression, the hematoma is cleared. This reduces the contact area between the balloon body and the vascular intima, lowers the withdrawal resistance, and minimizes contact between the balloon body and the vascular intima, thus preventing excessive intimal proliferation.

[0013] In one embodiment of this utility model, the beaded balloon structure includes two or more balloon bodies, which are arranged along the extension direction of the connecting tube and are interconnected.

[0014] Thus, during use, two or more of the aforementioned balloon bodies can compress the coronary artery dissection hematoma more than twice, improving the efficiency of the beaded balloon structure in clearing the coronary artery dissection hematoma.

[0015] In one embodiment of this utility model, the maximum diameters of two adjacent balloon bodies are the same.

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

[0017] In one embodiment of this utility model, the first contact portions of two adjacent balloon bodies have the same cross-sectional length in the extending direction of the connecting tube.

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

[0019] In one embodiment of this utility model, 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 coronary artery dissection hematoma can be squeezed three times of the same size by three balloon bodies, thereby improving the clearance efficiency and effect of coronary artery dissection hematoma removal.

[0021] In one embodiment of this utility model, the first inclined portion and the second inclined portion are arc-shaped structures. The first inclined portion protrudes in a direction away from the center of the balloon body, and the second inclined portion is recessed in a direction close to the center line of the connecting tube.

[0022] Thus, the first inclined portion protrudes away from the center of the balloon body, and the second inclined portion is recessed towards the center line of the connecting tube. A pointed structure is formed on the right side of the second inclined portion of the balloon body, which makes it easier to squeeze the coronary artery dissection hematoma and insert it between the coronary artery dissection hematomas when the balloon body is retracted. A support structure is formed on the left side of the first inclined portion of the balloon body, which pushes the first contact portion upward and provides support for the first contact portion.

[0023] In one embodiment of this utility model, the connecting tube has a distal end and a proximal end, the first inclined portion is disposed relative to the distal end, the second inclined portion is disposed relative to the proximal end, and the second inclined portion extends in a direction close to the proximal end.

[0024] Thus, during use, the balloon body is inserted into the distal end of the coronary artery dissection hematoma, inflated, and then withdrawn towards the proximal end of the hematoma. The second inclined portion forms a pointed structure that is inserted between the hematomas. The first contact portion compresses the hematoma, and the second inclined portion supports the first contact portion, facilitating the compression of the hematoma by the balloon body and reducing the resistance to withdrawal.

[0025] In one embodiment of the present invention, 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.

[0026] Thus, 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, which facilitates the processing of the balloon body.

[0027] In one embodiment of this utility model, the cross-sectional length of the first contact portion in the extending direction of the connecting pipe is 0.8mm to 1.2mm.

[0028] Thus, the cross-sectional length of the contact surface of the existing balloon body is 10mm-15mm, while the cross-sectional length of the first contact part of this application is 0.8mm-1.2mm, which greatly reduces the contact area between the balloon body and the vascular intima, reduces the retraction resistance, avoids excessive contact between the balloon body and the vascular intima, and avoids excessive proliferation of the vascular intima.

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

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

[0031] The balloon body is inserted into the distal end of the coronary artery dissection hematoma along the direction of the guidewire extension, and the balloon body is inflated.

[0032] The inflated balloon body is retracted towards the proximal end of the coronary artery dissection hematoma and the hematoma is compressed.

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

[0034] Unlike existing technologies, the method of this application involves using a balloon body 0.5-1 mm smaller than the diameter of the blood vessel. This balloon is advanced along a guidewire to the distal end of the coronary artery dissection hematoma, inflated, and then slowly withdrawn. This method effectively drives the hematoma back to the proximal end of the blood vessel and drains it from the dissection inlet, restoring coronary blood flow far better than the balloon hematoma decompression technique. The balloon body contacts the coronary artery dissection hematoma through a first contact portion. The cross-sectional length of the first contact portion is smaller than a preset size, reducing the contact area between the balloon body and the vascular intima. This reduced contact area lowers the withdrawal resistance, minimizes contact between the balloon body and the vascular intima, and prevents excessive intimal proliferation.

[0035] The above description of the utility model is merely an overview of the technical solution of this application. In order to enable those skilled in the art to better understand the technical solution of this application and to implement it based on the description and drawings, and to make the above-mentioned objectives and other objectives, features and advantages of this application easier to understand, the following description is provided in conjunction with the specific embodiments and drawings of this application. Attached Figure Description

[0036] The accompanying drawings are only used to illustrate the principles, implementation methods, applications, features, and effects of specific embodiments of this application and other related content, and should not be considered as limitations on this application.

[0037] In the accompanying drawings of the instruction manual:

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

[0039] Figure 2 This is a schematic diagram of a beaded balloon structure according to an embodiment of this application;

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

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

[0042] Figure 5 This is a schematic diagram illustrating the usage process of a beaded balloon structure for balloon withdrawal to clear coronary artery dissection hematoma according to an embodiment of this application;

[0043] Figure 6 Example of a case in this application Figure 1 ;

[0044] Figure 7 Example of a case in this application Figure 2 ;

[0045] Figure 8 Example of a case in this application Figure 3 ;

[0046] Figure 9 Example of a case in this application Figure 4 ;

[0047] The reference numerals used in the above figures are explained as follows:

[0048] A. The contact surface of an existing balloon body; a. The contact surface of the balloon body of this application;

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

[0050] c. The center direction of the balloon body; d. The centerline 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 Implementation

[0054] To illustrate the possible application scenarios, technical principles, implementable specific solutions, and achievable objectives and effects of this application in detail, the following description, in conjunction with the listed specific embodiments and accompanying drawings, provides a detailed explanation. The embodiments described herein are merely illustrative of the technical solutions of this application and are therefore intended to limit the scope of protection of this application.

[0055] In this document, the term "embodiment" means that a specific feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The term "embodiment" appearing in various places throughout the specification does not necessarily refer to the same embodiment, nor does it specifically limit its independence or connection with other embodiments. In principle, in this application, as long as there are no technical contradictions or conflicts, the technical features mentioned in each embodiment can be combined in any way to form corresponding implementable technical solutions.

[0056] Unless otherwise defined, the technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the use of related terms herein is merely for the purpose of describing particular embodiments and is not intended to limit this application.

[0057] In the description of this application, the term "and / or" is used to describe the logical relationship between objects, indicating that three relationships can exist. For example, "a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma and / or B" means: there is a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma, and there is B; or there are three cases where both a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma and B exist simultaneously. Additionally, the character " / " in this document generally indicates that the preceding and following objects have an "or" logical relationship.

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

[0059] Without further limitations, the use of terms such as “comprising,” “including,” “having,” or other similar open-ended expressions in this application is intended to cover non-exclusive inclusion, which does not exclude the presence of additional elements in a process, method, or product that includes the stated elements, such that a process, method, or product that includes a list of elements may include not only those defined elements but also other elements not expressly listed, or elements inherent to such a process, method, or product.

[0060] Similar to the understanding in the Examination Guidelines, in this application, expressions such as "greater than," "less than," and "exceeding" are understood to exclude the stated number; expressions such as "above," "below," and "within" are understood to include the stated number. Furthermore, in the description of the embodiments in this application, "multiple" means two or more (including two), and similar expressions related to "multiple" are also understood in this way, such as "multiple groups" and "multiple times," unless otherwise explicitly specified.

[0061] In the description of the embodiments of this application, the space-related expressions used, such as "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "vertical," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," indicate the orientation or positional relationship based on the orientation or positional relationship shown in the specific embodiments or drawings. They are only for the purpose of describing the specific embodiments of this application or for 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, they should not be construed as limitations on the embodiments of this application.

[0062] Unless otherwise expressly specified or limited, the terms "installation," "connection," "linking," "fixing," and "setting," as used in the description of the embodiments of this application, should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral arrangement; it can be a direct connection or an indirect connection through an intermediate medium; it can be a relationship of two components combined together, an interaction relationship between two components, or a connection within two structures. Those skilled in the art to which this application pertains can understand the specific meaning of the above terms in the embodiments of this application according to the specific circumstances.

[0063] In existing technologies, hematoma-targeted decompression mainly uses a cutting balloon for local expansion, employing a blade on the balloon surface to cut the intima of the hematoma, promoting blood drainage into the true lumen. However, this method has a very low success rate. Extended stent coverage technology requires intravascular ultrasound to clearly identify the distal end of the hematoma and then using a stent extending at least 5mm beyond the distal end to cover it, preventing the hematoma from spreading distally. However, excessively long stent implantation can lead to adverse consequences such as in-stent thrombosis and in-stent restenosis.

[0064] To address the aforementioned clinical problems, the inventors 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., a 2.0 or 1.5 mm balloon if the hematoma is in a 2.5 mm vessel), advanced along the guidewire to the distal end of the hematoma, inflated, and then slowly withdrawn. This method effectively drives the hematoma back to the proximal end of the vessel and drains it from the dissection inlet, restoring coronary blood flow far better than the cutting balloon hematoma decompression technique.

[0065] However, the existing balloon body has a contact surface with a cross-sectional length of 10mm-15mm, which increases the contact area between the balloon body and the vascular endothelium, resulting in greater retraction resistance. Furthermore, excessive contact between the balloon body and the vascular endothelium can stimulate the vascular endothelium, leading to its excessive proliferation.

[0066] Therefore, there is an urgent need for a novel balloon structure specifically designed for small balloon low-pressure retraction technology (SBLP technology).

[0067] In view of this, embodiments of this application provide a beaded balloon structure for balloon retraction to remove coronary artery dissection hematoma 3, including a connecting tube 1 and at least one balloon body 2. The balloon body 2 is disposed on the connecting tube 1 and 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 protruding 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 intima is reduced, the retraction resistance is reduced, the contact between the balloon body 2 and the vascular intima is reduced, and excessive proliferation of the vascular intima is avoided.

[0068] Please see Figures 1 to 9 This embodiment relates to a beaded balloon structure for balloon retraction to remove coronary artery dissection hematoma 3, including a connecting tube 1 and at least one balloon body 2; the balloon body 2 is disposed on the connecting tube 1 and 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 protruding 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. A set of first inclined portions 21, first contact portions 22 and second inclined portions 23 are provided at both the upper and lower ends of the connecting tube 1.

[0069] like Figure 1As shown, the existing balloon body 2 is a flat ellipse along the direction of blood vessel extension. The contact surface A of the existing balloon body is relatively large. 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 10mm-15mm.

[0070] like Figure 2 As shown, the improved balloon body 2 has a flat structure along the width 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 in this application is smaller. 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 0.8mm-1.2mm, 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 intima is greatly reduced, which can reduce the retraction resistance and effectively drive the hematoma back to the proximal end of the blood vessel and drain it from the dissection entrance.

[0071] The principle of the balloon body 2 is the same as that of the rapid exchange balloon. It can be inserted through a guidewire and sent into the dissected blood vessel. It can be inflated by injecting gas or liquid. The specific principle is a conventional technical means, which will not be elaborated 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, then a balloon body 2 with a diameter of 2.0mm or 1.5mm 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 diameter of the target vessel, insert the balloon into the distal end of the coronary hematoma along the guidewire, inflate it at 4-6 atm and slowly withdraw it. Repeating this 2-3 times can effectively restore blood flow.

[0074] Unlike existing technologies, the above technical solution includes a first inclined portion 21, a first contact portion 22, and a second inclined portion 23 in the balloon body 2. 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 protruding 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.

[0075] Thus, the first inclined portion 21, the first contact portion 22, and the second inclined portion 23 form a protruding structure. The top of the protruding structure is the first contact portion 22. The balloon body 2 contacts the coronary artery 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 intima. During use, the balloon body 2 is inserted into the distal end of the coronary artery dissection hematoma 3, and the balloon body 2 is inflated. The inflated balloon body 2 is then withdrawn towards the proximal end of the coronary artery dissection hematoma 3, and the coronary artery dissection hematoma 3 is squeezed through the first contact portion 22. By repeatedly withdrawing and squeezing, the coronary artery dissection hematoma 3 is cleared. This reduces the contact area between the balloon body 2 and the vascular intima, reduces the withdrawal resistance, and minimizes the contact between the balloon body 2 and the vascular intima, thus preventing excessive proliferation of the vascular intima.

[0076] According to some embodiments of this application, optionally, the beaded balloon structure includes two or more balloon bodies 2, which are arranged along the extension direction of the connecting tube 1 and are interconnected.

[0077] like Figure 3 As shown, in some embodiments, the beaded balloon structure consists of two balloon bodies 2, which are arranged along the direction of the blood vessel. One retraction can compress the coronary artery dissection hematoma 3 twice.

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

[0079] According to some embodiments of this application, optionally, two adjacent balloon bodies 2 have the same maximum diameter.

[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 length of the first contact part 22 of the two balloon bodies 2 in the extension direction of the connecting tube 1 is the same.

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

[0082] According to some embodiments of this application, optionally, the first contact portions 22 of two adjacent balloon bodies 2 have the same cross-sectional length in the extending direction of the connecting tube 1.

[0083] Thus, the contact area of ​​the first contact portion 22 of the two adjacent balloon bodies 2 is smaller than the preset size, and the contact area of ​​the first contact portion 22 of the two adjacent balloon bodies 2 is the same, which reduces the contact area between the balloon body 2 and the vascular intima and reduces the retraction resistance.

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

[0085] like Figure 3 As shown, in some embodiments, the beaded balloon structure consists of three balloon bodies 2, which are arranged along the direction of the blood vessel, and one retraction can compress the coronary artery dissection hematoma 3 three times.

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

[0087] In this way, the coronary artery dissection hematoma 3 can be squeezed three times of the same size by three balloon bodies 2, thereby improving the clearance efficiency and effect of the coronary artery dissection hematoma 3.

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

[0089] like Figure 2 As shown, the first inclined part 21 protrudes outward toward the center of the balloon body (arrow c), and the second inclined part 23 is concave inward toward the center line of the connecting tube (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 inlet of the blood vessel dissection. At this time, the second inclined part 23 is relatively pointed, which facilitates entry between the hematoma above and below the blood vessel, and the first inclined part 21 is relatively round, which facilitates support of the first contact part 22.

[0090] Thus, the first inclined portion 21 protrudes towards the center away from the balloon body 2, and the second inclined portion 23 is recessed towards the center line of the connecting tube 1. A pointed structure is formed on the right side of the second inclined portion 23 of the balloon body 2, which makes it easier to squeeze the coronary artery dissection hematoma 3 and insert it between the coronary artery dissection hematoma 3 when the balloon body 2 is retracted. A support structure is formed on the left side of the first inclined portion 21 of the balloon body 2, which pushes the first contact portion 22 upward and provides support for the first contact portion 22.

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

[0092] Thus, during use, the balloon body 2 is inserted into the distal end of the coronary artery dissection hematoma 3, the balloon body 2 is inflated, and the inflated balloon body 2 is withdrawn towards the proximal end of the coronary artery dissection hematoma 3. The second inclined part 23 forms a pointed structure and is inserted between the coronary artery dissection hematomas 3. The first contact part 22 compresses the coronary artery dissection hematoma 3, and the second inclined part 23 supports the first contact part 22, which facilitates the balloon body 2 to compress the coronary artery dissection hematoma 3 and reduces the withdrawal resistance.

[0093] According to some embodiments of this application, optionally, the first inclined portion 21 protrudes in 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 in a direction away from the center of the balloon body 2.

[0094] like Figure 3 and Figure 4 As shown, the first inclined part 21 protrudes outward in the direction of arrow c toward the center of the balloon body, and the second inclined part 23 protrudes outward in the direction of arrow c toward the center of the balloon body, forming a symmetrical structure, which facilitates the production of the balloon body 2, improves production efficiency, and reduces the defect rate.

[0095] Thus, the first inclined portion 21 protrudes in 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 the processing of the balloon body 2.

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

[0097] Thus, the cross-sectional length of the contact surface of the existing balloon body 2 is 10mm-15mm, while the cross-sectional length of the first contact part 22 in this application is 0.8mm-1.2mm, which greatly reduces the contact area between the balloon body 2 and the vascular intima, reduces the retraction resistance, avoids excessive contact between the balloon body 2 and the vascular intima, and avoids excessive proliferation of the vascular intima.

[0098] Secondly, this embodiment also relates to a method of using a beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma, including the beaded balloon structure for balloon withdrawal to remove coronary artery dissection hematoma as described in any of the above, comprising the following steps:

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

[0100] The balloon body 2 is inserted into the distal end of the coronary artery dissection hematoma 3 along the direction of the guidewire extension, and the balloon body 2 is inflated.

[0101] The inflated balloon body 2 is retracted towards the proximal end of the coronary artery dissection hematoma 3, and the coronary artery dissection hematoma 3 is compressed.

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

[0103] like Figure 5 As shown, before performing balloon withdrawal 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). The balloon body 2 is inserted into the distal end of the coronary artery dissection hematoma 3 (the right end in the figure) along the direction of the guidewire extension, and the balloon body 2 is inflated. The inflated balloon body 2 is withdrawn towards 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 fluid 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] Unlike existing technologies, the method of this application involves using a balloon body 2 that is 0.5-1 mm smaller than the diameter of the blood vessel. This balloon is advanced along the guidewire to the distal end of the coronary artery dissection hematoma 3, inflated, and then slowly withdrawn. This method effectively drives the hematoma back to the proximal end of the blood vessel and drains it from the dissection inlet, restoring coronary blood flow much better than the balloon hematoma decompression technique. The balloon body 2 contacts the coronary artery dissection hematoma 3 through a 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 intima. This reduces the contact area between the balloon body 2 and the vascular intima, lowers the withdrawal resistance, and reduces the contact between the balloon body 2 and the vascular intima, thus preventing excessive proliferation of the vascular intima.

[0105] like Figures 6 to 9 As shown, this application discloses the successful application of the small balloon low-pressure withdrawal technique in 4 patients who developed CIMH during PCI. The efficacy of the procedure was assessed using the TIMI (Thrombolysis in Myocardial Infarction) flow grading system. All 4 patients achieved TIMI grade III flow postoperatively, indicating complete restoration of distal blood flow. The results demonstrate that the small balloon low-pressure withdrawal technique is a promising minimally invasive treatment for CIMH, restoring blood flow while carrying a very low risk of iatrogenic injury.

[0106] Patient 1: A 45-year-old female presenting with chest pain. Laboratory tests showed elevated troponin T levels, and coronary angiography revealed 80% stenosis of the distal left main coronary artery (LM). Figure 6 A). Therefore, we attempted left anterior descending artery (LAD)-LM crossover PCI. Following treatment of the LM artery lesion with a 2.5mm Wolverine cutting balloon (Boston Scientific), angiography revealed new stenosis in the LAD artery ( Figure 6B). Intravascular ultrasound (IVUS) confirmed that CIMH extended from the distal LM to the mid-LAD. Figure 6 C). Due to hematoma, blood flow to the LAD is poor ( Figure 6 D). We then used a 2.5mm cutting balloon to drain CIMH ( Figure 6 E), but this failed to improve blood flow. Finally, we performed the small balloon low-pressure pullback technique (SBLP): a 2.0 mm balloon was inflated to 2 atmospheres, and then the balloon was pulled back into the guiding catheter (E). Figure 6 F). Angiography showed TIMI grade 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) in the mid-segment of the left aorta (LAD) and subtotal occlusion of the posterolateral artery (PLA), with distal TIMI grade 1 flow. Figure 7 A). Following the implantation of a 2.5*23mm stent, distal blood flow deteriorated, considered to be CIMH caused by stent implantation. Figure 7 C). We used a 2.0 mm balloon inflated to 2 atmospheres and pulled back the guiding catheter to perform the Small Balloon Low Pressure Withdrawal Technique (SBLP). Figure 7 D), to restore distal TIMI grade 3 blood flow ( Figure 7 E).

[0108] Patient 3: A 77-year-old male was admitted to the hospital due to chest pain and anterior wall Q waves on electrocardiogram. Coronary angiography showed CTO in the mid-LAD ​​segment. Figure 8 A) PCI was planned for the CTO of the LAD. Multiple guidewires were used, such as Runthrough, Field XTR, and GAIA, and finally, a Pilot 150 (Abbott Laboratories) was inserted distally into the true lumen. Figure 8 C). IVUS showed that anterograde guidewire technique caused diffuse CIMH with TIMI grade 1 flow ( Figure 8 D). Subsequently, the 2.0 mm balloon was inflated to 2 atmospheres and the guiding catheter was pulled back. Figure 8 E), immediately resolved CIMH ( Figure 8 F). After implanting three stents, the surgery was completed, and TIMI grade 3 blood flow was achieved. Figure 8 G).

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

[0110] Small balloon low-pressure withdrawal (SBLP) represents a significant advance in the management of intramural hematoma (CIMH). Unlike traditional methods that may worsen the condition or fail to restore blood flow, SBLP is a minimally invasive approach that effectively removes the hematoma while minimizing the risk of iatrogenic injury. In our case series, all four patients achieved TIMI Grade III flow after SBLP, regardless of the underlying mechanism of CIMH (post-stent, post-balloon dilation, or post-chronic total occlusion guidewire technique). This consistent success with CIMH of various etiologies underscores the versatility and potential broad applicability of this technique.

[0111] Small balloon low-pressure withdrawal (SBLP) offers several key advantages over traditional methods. By gently squeezing the hematoma proximally, it minimizes the risk of distal hematoma extension (a common complication of additional stent placement or cutting balloon angioplasty). Furthermore, SBLP rapidly restores coronary blood flow, reducing the risk of myocardial ischemia and hemodynamic instability. This rapid resolution is crucial for preventing further complications associated with prolonged blood flow obstruction. Additionally, the technique requires only standard PCI equipment, making it a more cost-effective alternative to more complex interventions. This feature not only enhances its accessibility but also facilitates 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 for this utility model. Therefore, any changes and modifications made to the embodiments described herein based on the innovative concept of this utility model, or equivalent structural or procedural transformations made using the content of this utility model's specification and drawings, directly or indirectly applying the above technical solutions to other related technical fields, are all included within the scope of patent protection for this utility model.

Claims

1. A beaded balloon structure for balloon retraction to clear coronary artery dissection hematoma, characterized in that, include: Connecting pipe; as well as At least one balloon body is disposed on the connecting tube and 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, and 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 less than a preset size. A set of first inclined portions, first contact portions, and second inclined portions are provided at both the upper and lower ends of the connecting tube.

2. The beaded balloon structure for balloon retraction to clear coronary artery dissection hematoma according to claim 1, characterized in that, The beaded balloon structure includes two or more balloon bodies, which are arranged along the extension direction of the connecting tube and are interconnected.

3. The beaded balloon structure for balloon retraction to clear coronary artery dissection hematoma according to claim 2, characterized in that, The two adjacent balloon bodies have the same maximum diameter.

4. The beaded balloon structure for balloon retraction to clear coronary artery dissection hematoma according to claim 3, characterized in that, The first contact portions of two adjacent balloon bodies have the same cross-sectional length in the extension direction of the connecting tube.

5. The beaded balloon structure for balloon retraction to clear 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 retraction to clear 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 protrudes in a direction away from the center of the balloon body, and the second inclined portion is recessed in a direction close to the center line of the connecting tube.

7. The beaded balloon structure for balloon retraction to clear 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 disposed relative to the distal end, the second inclined portion is disposed relative to the proximal end, and the second inclined portion extends in a direction close to the proximal end.

8. The beaded balloon structure for balloon retraction to clear 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 also protrudes in a direction away from the center of the balloon body.

9. The beaded balloon structure for balloon withdrawal to clear coronary artery dissection hematoma according to any one of claims 1-8, characterized in that, The first contact portion has a cross-sectional length of 0.8 mm to 1.2 mm in the extending direction of the connecting pipe.

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