A balloon

Abstract

This invention relates to the field of medical device technology and provides a balloon, comprising: a balloon body; and occlusion rings. Multiple occlusion rings are spaced apart on the outer surface of the balloon body along its axial direction. Each occlusion ring has at least one through-hole penetrating its wall thickness. When the balloon body inflates, adjacent occlusion rings and the blood vessel wall together form a buffer cavity. The balloon provided by this invention has multiple occlusion rings on the outer surface of the balloon body, each occlusion ring having at least one through-hole penetrating its wall thickness. When the balloon body inflates, adjacent occlusion rings and the blood vessel wall together form a buffer cavity. This configuration allows blood pressure to be gradually reduced as it flows through the continuous buffer cavities after balloon inflates. High-pressure blood from the distal end of the balloon is buffered and depressurized, becoming low-pressure blood flow, achieving the effect of occlusion without complete blockage. This reduces significant blood loss and prevents ischemia and necrosis of downstream tissues.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a balloon. Background Technology

[0002] Aortic balloon occlusion is an interventional technique that involves inserting a balloon catheter into the aorta via the femoral artery and temporarily blocking blood flow to the aorta after inflation. Its purpose is to control non-compressible bleeding within the trunk, thereby increasing perfusion to the heart and brain and improving the survival rate of trauma patients. However, traditional aortic occlusion balloons completely block blood flow during balloon inflation, and prolonged occlusion can cause damage to body tissues. Summary of the Invention

[0003] Therefore, the present invention aims to solve the problem that in the prior art, aortic occlusion balloons completely block blood flow during balloon expansion, and prolonged blood flow blockage can cause damage to body tissues, thereby providing a balloon.

[0004] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: The present invention provides a balloon, comprising: a balloon body; occlusion rings, wherein a plurality of occlusion rings are spaced apart on the outer surface of the balloon body along the axial direction of the balloon body; each occlusion ring is provided with at least one through hole penetrating its wall thickness; when the balloon body is inflated, two adjacent occlusion rings together form a buffer cavity with the blood vessel wall.

[0005] Furthermore, the through holes on two adjacent blocking rings are staggered from each other in the circumferential direction of the balloon body.

[0006] Furthermore, the through holes on two adjacent blocking rings are offset by an angle of 30°-60° in the circumferential direction.

[0007] Furthermore, the through holes on two adjacent blocking rings are offset by an angle of 45° in the circumferential direction.

[0008] Furthermore, multiple occlusion rings are distributed at equal intervals on the outer surface of the balloon body.

[0009] Furthermore, the occlusion ring and the balloon body are integrally formed from the same polymer material, or are fixedly connected by bonding or heat sealing.

[0010] Furthermore, the through hole is a variable diameter hole, and the orifice on the distal end face of the blocking ring is larger than the orifice on the proximal end face; the diameter of the through hole is changed through a spiral worm tube channel.

[0011] Furthermore, a filter membrane for limiting blood flow is provided inside the through hole.

[0012] Furthermore, the filter membrane is provided with multiple micropores for blood to pass through.

[0013] Furthermore, the micropores on the filter membrane are uniformly distributed in a ring array.

[0014] The technical solution of this invention has the following advantages: The balloon provided by this invention has multiple occlusion rings on the outer surface of the balloon body. Each occlusion ring has at least one through hole penetrating its wall thickness. When the balloon body is inflated, two adjacent occlusion rings and the blood vessel wall together form a buffer cavity. With this configuration, when the balloon is inflated, the blood pressure can be gradually reduced as the blood flows through the continuous buffer cavities. High-pressure blood becomes low-pressure blood flow after being buffered and depressurized from the distal end of the balloon, achieving the effect of occlusion without complete blockage. This can reduce the loss of large amounts of blood and prevent ischemia and necrosis of downstream tissues. Attached Figure Description

[0015] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0016] Figure 1 This is a three-dimensional structural schematic diagram of a balloon provided in one embodiment of the present invention; Figure 2 This is a front view of a balloon provided in one embodiment of the present invention; Figure 3 This is a cross-sectional view of a balloon provided in one embodiment of the present invention; Figure 4 yes Figure 3 Enlarged view of region A in the middle; Figure 5 This is a schematic diagram of a balloon in use according to an embodiment of the present invention; Figure 6 yes Figure 5 Enlarged view of region B in the middle; Figure 7 This is a schematic diagram of the microstructure of the filter membrane in a balloon provided in an embodiment of the present invention; Figure 8 This is a three-dimensional structural schematic diagram of a balloon provided in another embodiment of the present invention; Figure 9 This is a front view of the balloon provided in another embodiment of the present invention; Figure 10 This is a cross-sectional view of a balloon provided in another embodiment of the present invention; Figure 11This is a schematic diagram of the distal end face of the occlusion ring in a balloon according to another embodiment of the present invention; Figure 12 This is a schematic diagram of the proximal end face of the occlusion ring in a balloon according to another embodiment of the present invention; Figure 13 This is a schematic diagram of a balloon in use according to another embodiment of the present invention; Figure 14 This is a schematic diagram of the blood flow direction after the buffer cavity in the balloon is deployed, according to an embodiment of the present invention.

[0017] Explanation of reference numerals in the attached figures: 1. Balloon body; 2. Blocking ring; 21. Through hole; 211. Spiral tube channel; 22. Filter membrane; 221. Micropore; 3. Blood vessel wall; 4. Buffer chamber. Detailed Implementation

[0018] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0020] In the description of this invention, it should be noted that, unless otherwise explicitly specified and defined, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0021] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0022] Example 1.

[0023] like Figures 1 to 4 As shown, this embodiment provides a partial aortic occlusion balloon. The core inventive concept of this balloon lies in the fact that, through multiple occlusion rings 2 spaced apart along the axial direction of the balloon body 1, and through holes 21 opened on the occlusion rings 2, a series of series-connected, closed fluid buffer chambers 4 are constructed together with the blood vessel wall 3 after the balloon expands. When high-pressure arterial blood flows through these continuous buffer chambers, its pressure can be dissipated and reduced step by step and stably, eventually forming a low-pressure, low-speed but continuous "trickle" at the distal end of the balloon. This concept solves the "all or nothing" dilemma of traditional aortic occlusion balloons at the system level, achieving a partial occlusion effect of "blocking without sealing off," which can effectively control non-compressible bleeding in the trunk and provide basic blood oxygen supply to downstream critical tissues such as the spinal cord and kidneys, thereby significantly prolonging the safety window period of surgery.

[0024] Among them, the balloon body 1 is the main component for achieving intravascular anchoring and sealing, and its design needs to take into account pushability, flexibility and rupture resistance.

[0025] The balloon body 1 is typically made of a medical polymer material with good flexibility, tensile strength, and low compliance. Suitable materials include, but are not limited to: nylon, polyethylene terephthalate, polyurethane, polyether block amide, or copolymers thereof.

[0026] Using low-compliance or non-compliance materials is a key choice in this technical solution because it ensures that once the balloon reaches its predetermined nominal diameter, its diameter will not increase significantly even with continued increases in inflation pressure. This characteristic brings two systemic benefits: first, it avoids shear or tensile damage to the vessel wall 3 caused by excessive balloon expansion, improving surgical safety; second, it ensures the stability and repeatability of the contact pressure between the occlusion ring 2 and the vessel wall 3, ensuring that the sealing effect of each buffer chamber 4 is not affected by minor fluctuations in balloon inflation pressure, thereby making the depressurization effect of distal blood flow highly predictable.

[0027] The balloon body 1 is folded in its uninflated state (usually with three, five, or more wings) to reduce its outer diameter, thus allowing it to pass smoothly through small-diameter (e.g., 8F-12F) vascular sheaths and tortuous vascular pathways. The folding design needs to be matched with the balloon wall thickness and material rigidity to ensure uniform and non-invasive deployment during inflation.

[0028] The effective working length of the balloon body 1 (i.e., the length of the segment where the occlusion ring 2 is distributed) can be designed according to the anatomical length of the target occlusion location (such as the subrenal abdominal aorta or thoracic aorta), preferably 30mm-120mm. The nominal diameter of the balloon body 1 should be selected according to the patient's aortic diameter, with common specifications including 12mm, 14mm, 16mm, 18mm, and 20mm, to meet the needs of patients of different body types.

[0029] Among them, the occlusion ring 2 is the core execution structure for realizing the "partial blockage" function of the present invention. Multiple occlusion rings 2 are distributed at intervals on the outer surface of the balloon body 1 along the axial direction (i.e., from the proximal end to the distal end).

[0030] The number of blocking rings 2 is a key parameter determining the number of pressure reduction stages and the final pressure reduction effect of the entire system. From the perspective of the fluid system, each "blocking ring 2 + through hole 21 + subsequent buffer chamber 4" constitutes a basic pressure reduction unit. Theoretically, the more pressure reduction units connected in series, the greater the total pressure drop, and the more stable and lower the output pressure at the far end.

[0031] However, too many occlusion rings 2 increase the overall length of the balloon, potentially limiting its use in some anatomically shorter main trunk locations (such as the subrenal abdominal aorta in some patients), while also increasing manufacturing costs and the outer diameter of the folded balloon. The preferred number of occlusion rings 2 is 3-6. In this embodiment, four occlusion rings 2 are used as an example, achieving a balance between pressure-reducing effect and structural compactness.

[0032] The occlusion ring 2 is structurally a ring-shaped protrusion that surrounds the balloon body 1. Its cross-sectional shape perpendicular to the axial direction is an important geometric parameter affecting the sealing effect and blood flow field characteristics. Various geometric shapes can achieve the basic function, including but not limited to: rectangles, trapezoids, semicircles, triangles, or trapezoids with rounded chamfers.

[0033] Different cross-sectional shapes systematically affect the contact stress distribution between the occlusion ring 2 and the vessel wall 3, as well as the turbulent flow characteristics of blood at the inlet of the buffer chamber 4. For example, a rectangular cross-section provides the largest contact area and sealing force, but may cause local stress concentration; a trapezoidal or trapezoidal cross-section with rounded chamfers can ensure good sealing while distributing contact stress more evenly at the top of the ring, reducing the risk of sharp cutting of the vascular intima and lowering the possibility of postoperative vascular dissection or spasm. A semi-circular cross-section provides good sealing while offering the gentlest obstruction to blood flow, potentially reducing collision damage to blood cells at the ring edge. In this embodiment, a trapezoidal cross-section with a rounded corner at the top is preferred.

[0034] Among them, the radial height of the occlusion ring 2 (i.e., the vertical height of the protrusion from the outer surface of the balloon body 1) is a crucial design parameter. From the perspective of system function, this height directly determines the initial contact pressure between the occlusion ring 2 and the blood vessel wall 3 after balloon inflation, as well as the effective volume of the buffer cavity 4.

[0035] If the radial height is too small, the occlusion ring 2 may not be able to form an effective and continuous circumferential line contact with the vessel wall 3 after the balloon inflates. This can cause some of the high-pressure blood to leak directly downstream through the tiny gap between the ring top and the vessel wall. This leakage is a fatal flaw that disrupts the function of the entire "step-down" blood pressure system.

[0036] Conversely, if the radial height is too large, the occlusion ring 2 will exert excessive local radial pressure on the vessel wall 3, which may lead to damage to the vascular intima, dissection, or even rupture. At the same time, an excessively large buffer lumen volume will also lead to a decrease in the overall compliance of the balloon and increase the pushing resistance.

[0037] The preferred range for the radial height is 1mm-5mm, more preferably 2mm-4mm, and in this embodiment, it is 3mm.

[0038] The axial width of the occlusion ring 2 (i.e., the length of the occlusion ring 2 along the balloon axis) also needs optimization. This width affects the structural stiffness of the occlusion ring 2, the width of the contact ring with the vessel wall 3, and the arrangement space of the through hole 21. If the width is too small, the annular structure may buckle circumferentially or roll over axially under the impact of high-pressure blood flow, losing its sealing function; if the width is too large, it will unnecessarily occupy the axial space of the balloon. Preferably, the axial width of the occlusion ring 2 is 1mm-3mm, and in this embodiment, it is 2mm.

[0039] The axial spacing between two adjacent occlusion rings 2 determines the axial length of each buffer chamber 4, which is a direct factor affecting the buffer chamber volume and blood flow residence time. A longer spacing provides a larger volume and a longer residence time, which is beneficial for more sufficient pressure stabilization and dissipation, but it also increases the total length of the balloon. This spacing is preferably 5mm-15mm, and in this embodiment, it is 10mm. This spacing, combined with the aforementioned radial height (3mm) and circumferential circumference (approximately 50mm), provides each buffer chamber 4 with a volume of approximately 1500mm³, which is sufficient to provide significant buffering and pressure stabilization.

[0040] The connection method between the occlusion ring 2 and the balloon body 1 determines the integrity and reliability of the entire balloon structure.

[0041] In a preferred embodiment, the occlusion ring 2 and the balloon body 1 are manufactured using the same polymer material (such as the same nylon material) through a one-piece molding process. For example, a balloon preform with the occlusion ring 2 can be directly printed using 3D printing technology, or the occlusion ring 2 can be directly formed during blow molding by designing a blow molding die with a corresponding cavity. The advantages of one-piece molding are that there are no seams between the two, the connection strength is high, there is no risk of delamination or peeling due to repeated filling and de-cavitation, the airtightness is excellent, and there are no biocompatibility issues that may be caused by adhesives.

[0042] In another alternative embodiment, the occlusion ring 2 can be injection molded or extruded separately and then bonded with medical-grade cyanoacrylate adhesive, or fixed to the outer surface of the pre-blown balloon body 1 by heat sealing or radio frequency welding. This modular manufacturing method requires less modification to existing balloon production lines and is easier to implement, but it requires strict control of the bonding or welding process parameters to ensure long-term reliability.

[0043] Each occlusion ring 2 has multiple through-holes 21 penetrating its wall thickness. The through-holes 21 are the only forced channels for blood to flow from the proximal side (high-pressure side) to the distal side (buffer chamber side) of the occlusion ring 2. The number, geometry, size, and internal structure of the through-holes 21 together determine the fluid resistance characteristics of a single pressure-reducing unit.

[0044] The number of through-holes 21 can be set according to the circumference and width of the occlusion ring 2. If the number of through-holes 21 is too small, the blood flow that each through-hole 21 needs to handle will be too large, resulting in excessively high local flow velocity and a jet effect, which may damage blood cells flowing through the filter membrane 22 (hemolysis). At the same time, the high-speed local jet will impact the blood vessel wall on the opposite side of the buffer chamber 4, causing unnecessary local high pressure. If the number of through-holes 21 is too large, it will weaken the structural strength of the occlusion ring 2 and complicate the manufacturing process. In addition, the impedance contributed by each through-hole will be reduced in parallel, resulting in a decrease in the total impedance and a weakening of the pressure reduction effect.

[0045] Preferably, each blocking ring 2 has 2-8 through holes 21, more preferably 4-6. In this embodiment, each blocking ring 2 has 4 evenly distributed through holes 21. The cross-sectional shape of the through holes 21 can be circular, elliptical, or oblong. Circular through holes are the easiest to process and have the most symmetrical and predictable hydrodynamic characteristics.

[0046] The aperture size of the through hole 21 directly affects the theoretical maximum blood flow per unit time. The aperture is preferably 0.5mm-3mm, more preferably 1.0mm-2.0mm. In this embodiment, the aperture of the through hole 21 is 1.5mm.

[0047] Among them, such as Figure 8 , Figure 9 , Figure 10 , Figure 11 , Figure 12 as well as Figure 13 As shown, in a more preferred embodiment, the through hole 21 is designed as a variable diameter hole, and the orifice on the distal end face (towards the distal end of the balloon) of the occlusion ring 2 is larger than the orifice on the proximal end face (towards the proximal end of the balloon); the diameter of the large and small orifices of the through hole 21 is changed through the spiral worm tube channel 211.

[0048] This structural design brings unique hydrodynamic advantages. As blood flows into the spiral cochlear duct channel 211 from the larger proximal orifice, the diameter gradually decreases, and the flow velocity gradually increases. More importantly, the spiral channel forces the fluid to rotate. This rotation generates centrifugal force, throwing denser blood cells toward the outer wall of the spiral tube, while less dense plasma moves closer to the center. This centrifugal separation effect, combined with the secondary flow generated as blood flows through the tortuous channel, greatly increases the path length of the blood flow and energy dissipation.

[0049] As blood rotates and propagates, its pressure gradient is continuously consumed to overcome viscous resistance and maintain rotational kinetic energy. When the blood finally exits from the smaller distal orifice, its pressure is significantly reduced, and its flow becomes more laminar and stable, minimizing the impact of turbulence on downstream tissues. This variable-diameter helical spiral tube structure can work in conjunction with the filter membrane 22 described later, and even replace the independent filter membrane 22 in some high-precision manufacturing solutions. It achieves partial flow blocking through the geometric limitation of the spiral channel itself, providing diverse options for product design.

[0050] Within each through-hole 21, a filter membrane 22 can be disposed. The filter membrane 22 is the direct component for achieving precise flow restriction and microfiltration. The filter membrane 22 is a porous thin film structure with a large number of uniformly sized micropores 221. From a system perspective, the filter membrane 22 is the main contributor to fluid resistance in the entire pressure reduction unit. Its presence allows the pressure reduction effect to no longer depend solely on macroscopic geometry, but to increase resistance across multiple orders of magnitude.

[0051] The filter membrane 22 can be made of a polymer material with good blood compatibility and chemical stability, such as expanded polytetrafluoroethylene (ePTFE), polyethersulfone, polypropylene, or polyethylene terephthalate. EPTFE membranes, due to their unique microfiber nodular structure, possess extremely high porosity and good flexibility, while also exhibiting excellent chemical inertness and anticoagulant properties, making them the preferred material.

[0052] like Figure 7As shown, the filtration accuracy of the filter membrane 22 is determined by the pore size and porosity of its micropores 221. The pore size of the micropores 221 determines the maximum particle size that can pass through, and also determines the theoretical flux under a given pressure difference. Since the diameter of human red blood cells is approximately 6-8 μm, while the diameters of white blood cells and platelets are slightly larger, the pore size of the micropores 221 cannot be too small, and should be at least greater than 10 μm, in order to prevent blood cells from rupturing due to extremely high shear stress when forcibly passing through the tiny pores (hemolysis). At the same time, in order to achieve a significant flow-limiting and pressure-reducing effect, the pore size of the micropores 221 cannot be too large.

[0053] After systematic consideration, the pore size of the micropores 221 is preferably 20μm-100μm, more preferably 30μm-60μm, and in this embodiment, 50μm is used. Porosity (the percentage of the total micropore area to the surface area of ​​the filter membrane) determines the total flow rate under the same pressure difference and pore size. Porosity is preferably 20%-50%. By selecting filter membranes 22 with different pore sizes and porosities, the fluid impedance of each pressure-reducing unit can be precisely "customized," much like selecting a resistance value, thereby achieving refined and predictable regulation of downstream blood flow pressure.

[0054] The filter membrane 22 can be fixed to the inner wall of the through hole 21 by heat sealing, ultrasonic welding or using medical-grade adhesive. The fixing method must ensure that it does not shift or break under balloon inflation pressure and blood flow impact that are several times higher than human arterial pressure.

[0055] One of the core inventive points of this invention lies in the systematic integration of the aforementioned structural features, resulting in a significant synergistic effect. For example... Figure 2 As shown, this embodiment adopts an arrangement in which "the through holes 21 on two adjacent blocking rings 2 are staggered in the circumferential direction of the balloon body 1". More specifically, the staggered angle of the through holes 21 on two adjacent blocking rings 2 in the circumferential direction is 30°-60°, and the optimal value of 45° is taken in this embodiment.

[0056] This means that if the four through holes on the first blocking ring (proximal side) are located at 12, 3, 6, and 9 o'clock, respectively, then the four through holes on the adjacent second blocking ring are located at 1:30, 4:30, 7:30, and 10:30. This feature may seem simple on its own, but when combined with the "blocking ring-buffer chamber-filter membrane" system, it produces revolutionary fluid control effects.

[0057] Next, we will combine Figure 5 , Figure 6 as well as Figure 14 This paper elaborates on the most critical, system-level fluid dynamics collaborative working mechanism of this device.

[0058] Once the balloon body 1 is inserted into the target location of the aorta and fully inflated to its nominal diameter, a tight fit is formed between the outer surface of the balloon body 1 and the aortic vessel wall 3. At this time, the tops of each occlusion ring 2 are in direct contact with the intima of the vessel wall 3, and under the pressure of inflation, a certain radial compression force is generated, which acts as a "sealing ridge". Thus, the four parts—two adjacent occlusion rings 2, the outer surface of the balloon body 1, and the inner surface of the vessel wall 3—together form a closed, annular cavity, which is the buffer cavity 4.

[0059] Along the axial direction of the balloon, from the proximal end (heart side) to the distal end (downstream side), multiple independent but connected buffer chambers 4 are sequentially formed (for example, a first buffer chamber is formed between the first and second occlusive rings, a second buffer chamber is formed between the second and third occlusive rings, and so on). These buffer chambers 4 connected in series constitute a multi-level pressure attenuation network.

[0060] Step 1: Primary Blood Pressure Reduction. When high-pressure, high-velocity, pulsating arterial blood flows from the proximal aorta to the balloon location, it first encounters the first (closest to the distal end) occlusion ring 2. Because the occlusion ring 2 is tightly fitted to the vessel wall 3, blood cannot pass directly over it. The only passage is the through-hole 21 on the occlusion ring 2. The high-pressure blood is thus "guided" into the through-hole 21 on the first occlusion ring 2 and passes through the internal filter membrane 22 (and / or the cochlear duct channel 211). The micropores 221 on the filter membrane 22 greatly increase blood flow resistance; as the channel radius decreases from the millimeter level (1.5 mm for the through-hole) to the micrometer level (50 μm for the micropores), the resistance increases exponentially. This causes the first significant drop in blood pressure and a significant slowdown in flow velocity.

[0061] Step Two: Primary Buffering. The blood passing through filter membrane 22 (now a low-pressure, low-velocity flow) then flows into the first buffer chamber formed by the first and second blocking rings. Because the first buffer chamber has a certain volume (e.g., axial length 10 mm, radial height 3 mm, circumferential circumference approximately 50 mm, volume approximately 1500 mm³), it acts as a "mechanical low-pass filter." The elastic volume of the buffer chamber absorbs the pulsating energy of the blood flow, stabilizing the pressure within the chamber and eliminating pressure spikes and flow velocity fluctuations caused by the alternation of systole and diastole.

[0062] Step 3: Forced Circumferential Flow and Secondary Pressure Reduction. Because the through-holes 21 on the second blocking ring and the first blocking ring are staggered at 45° in the circumferential direction, the blood in the first buffer chamber 4 cannot "straight through" the through-holes 21 of the second blocking ring. The blood is forced to change its flow direction within the first buffer chamber 4, starting from the injection point and flowing circumferentially along the annular cavity to "find" the through-holes 21 of the second blocking ring located at other angles. This process forces the blood to generate complex secondary flows, eddies, and boundary layer separation phenomena within the buffer chamber 4. These flow phenomena greatly increase the internal friction and energy dissipation of the fluid, continuously converting the macroscopic kinetic energy of the blood flow into heat energy. As the blood travels a certain distance within the buffer chamber, its pressure and velocity further decrease. When the blood finally finds and enters the through-hole 21 of the second blocking ring, its pressure and velocity have already decreased by a step compared to when it left the first blocking ring.

[0063] Step 4: Repeated Cycle. The above-described cycle of "pressure reduction-buffering-forced circumferential flow-re-pressure reduction" occurs repeatedly in each pressure-reducing unit consisting of "blocking ring 2 + through-hole 21 + buffer chamber 4". Each time blood passes through a unit, a portion of its pressure energy is systematically and steadily dissipated. After 3-4 such units acting in series, the pressure of the blood finally flowing out from the through-hole 21 of the furthest blocking ring 2 has decreased to a very low, non-destructive level.

[0064] The balloon structure of this embodiment (4 occlusion rings, 50μm filter membrane pore size, and 45° staggered through-holes) can stably control distal blood flow pressure between 20% and 50% of the proximal aortic pressure. The clinical effect of this systemic synergy is revolutionary: the distal balloon does not experience zero pressure as in traditional complete occlusion, nor does it exhibit drastic pressure fluctuations as in partially inflated balloons. It provides stable, continuous, and adjustable low-pressure perfusion. This pressure level (e.g., maintaining a mean arterial pressure above 30 mmHg) is sufficient to meet the basic metabolic needs of ischemic tissues such as the spinal cord and kidneys, thereby extending the safe time for aortic occlusion from the traditionally accepted 30-60 minutes to several hours.

[0065] Meanwhile, because the distal tissues did not experience severe and prolonged complete ischemia, the accumulation of harmful metabolites such as lactic acid, potassium ions, and inflammatory factors was significantly reduced. When the surgery was completed, the balloon was finally removed, and full blood flow was restored, the concentration of harmful substances entering the circulatory system was far below the threshold that would cause systemic reperfusion injury, thus effectively avoiding the "release clamp syndrome" commonly seen after traditional complete occlusion, a fatal complication that can lead to cardiac arrest, severe hypotension, and multiple organ failure.

[0066] Example 2.

[0067] This embodiment is based on Embodiment 1, with structural optimization and functional expansion, aiming to further enhance the clinical applicability and ease of operation of the balloon system.

[0068] In this embodiment, a balloon catheter 5 is connected to the proximal end of the balloon body 1. The balloon catheter 5 is a channel for delivering the balloon into the body and for inflation / deflation. To simultaneously achieve balloon inflation, guidewire passage, and possible distal pressure monitoring, the balloon catheter 5 is designed as a multi-lumen catheter.

[0069] The balloon catheter 5 includes at least one inflation chamber communicating with the interior of the balloon body 1. The distal end of the inflation chamber opens into the interior of the balloon body 1, and the proximal end is equipped with a standard Luer connector for connecting a pressure pump to inject or withdraw the inflation medium (usually a mixture of saline and contrast agent, typically in a 1:1 ratio). The use of contrast agent allows the operator to observe the inflation morphology and position of the balloon in real time under X-ray fluoroscopy, ensuring that the occlusion ring 2 is accurately located in the target blocking area.

[0070] The balloon catheter 5 also includes a guidewire lumen that extends the entire length of the catheter. The distal end of the guidewire lumen opens at the distal or further distal catheter tip of the balloon body 1, while the proximal end has a guidewire inlet. The presence of the guidewire lumen allows for “rapid exchange” or “coaxial” delivery of the balloon catheter along a pre-positioned 0.035-inch or 0.018-inch guidewire within the vessel. This significantly improves catheter accessibility and positioning accuracy in complex, tortuous vascular anatomy and is a standard feature of interventional procedures.

[0071] In a more preferred embodiment, the balloon catheter 5 may further include a third cavity, a pressure monitoring cavity. The distal opening of this cavity may be located on the distal side of the distal occlusion ring 2 (i.e., downstream of the balloon, near the catheter tip), and the proximal end is connected to a pressure sensor interface.

[0072] This independent, saline-filled cavity connects to an external pressure sensor, allowing surgeons to monitor distal aortic pressure in real-time and dynamically during surgery. This feature enables closed-loop feedback control: surgeons can precisely assess the partial occlusion effect of the balloon based on pressure readings (e.g., whether distal pressure is 20%-50% of proximal pressure). If distal pressure is too high, it indicates insufficient occlusion, and a balloon with a smaller pore size can be considered; if distal pressure is too low, it suggests potential over-occlusion or thrombosis, allowing for timely adjustments to the strategy. This real-time pressure monitoring significantly improves the safety and precision of treatment.

[0073] To accurately locate the balloon's axial and circumferential position within the aorta under X-ray, radiopaque markers can be placed on the proximal or distal end of the balloon body 1 or on the occlusion ring 2. These markers can be platinum or tantalum rings fitted onto the catheter, or platinum-iridium alloy ink printed or embedded in the balloon material. Alternatively, contrast agents such as barium sulfate or bismuth subcarbonate can be incorporated into the material used to manufacture the balloon body 1 or occlusion ring 2, ensuring uniform radiopaque visualization of the entire balloon structure under X-ray, facilitating overall positioning.

[0074] The above embodiments provide a detailed description of the structure of the present invention. However, those skilled in the art should understand that, without departing from the core inventive concept of the present invention, namely, "using axially distributed multi-level annular protrusions to form a series buffer cavity with the blood vessel wall, and achieving stepwise dissipation of blood flow and stable pressure reduction through restrictive channels (through holes / filter membranes) and circumferential staggered arrangement," various equivalent substitutions or modifications can be made to some specific features, and these substitutions or modifications also fall within the protection scope of the present invention.

[0075] In addition to trapezoidal or rectangular shapes, the cross-section of the occlusion ring 2 can also be designed as a "labyrinth seal" with multiple micro-tooth structures. This complex cross-section can significantly increase the flow path length and local resistance of blood leakage from the ring apex to the vessel wall, thereby improving the sealing effect without significantly increasing the radial height.

[0076] In this design, the filter membrane 22 is not necessarily a standalone thin film. In an alternative approach, a large number of micropores can be directly ablated into the solid body of the blocking ring 2 using a high-energy laser (such as a femtosecond laser), transforming the bulk material of the blocking ring 2 into a porous "filtration zone" in that area. This method achieves a perfect fusion of the through-hole 21 and the filter membrane 22, eliminating interface connection problems, resulting in a more robust structure, and theoretically enabling the realization of more complex three-dimensional microporous networks.

[0077] While 45° is the preferred angle, any angle other than 0° or 180° (i.e., non-axially aligned), such as 30°, 60°, or 90°, should be considered as a technical solution covered by this patent, as long as it can force blood to flow circumferentially within the buffer chamber 4, thereby increasing flow resistance and energy dissipation.

[0078] Different crossover angles correspond to different fluid resistance characteristics: a 90° crossover produces the strongest turbulence and the greatest energy dissipation, but may lead to excessively high resistance and reduce the total distal flow rate; a 30° crossover results in weaker turbulence but a larger total flow rate, with a relatively gentler pressure reduction effect. Clinicians can choose products with different crossover angles based on their specific needs (whether lower distal pressure or greater distal flow rate is required).

[0079] In addition to an equidistant distribution, the occlusion rings 2 can also be distributed non-equidistantly. For example, the proximal occlusion rings can be spaced further apart, forming a larger buffer cavity to facilitate the initial capture of high-pressure blood flow and achieve significant pressure reduction and stabilization; the distal occlusion rings can be spaced closer together, forming a smaller buffer cavity for fine-tuning of pressure. This non-uniform distribution design can further optimize the overall pressure-flow characteristic curve of the entire balloon system, making it closer to the ideal linear or logarithmic decay model.

[0080] While 3-6 loops are the preferred range, for certain specific applications, such as long-term occlusion requiring extremely low distal flow, more than 6 loops may be used; for temporary partial occlusion requiring only slight pressure reduction, 2 loops may suffice. The number of loops should be systematically selected and matched based on the diameter of the target vessel, the expected occlusion time, and the required distal perfusion pressure.

[0081] In summary, this application provides a cleverly structured and reliable aortic partial occlusion balloon that fundamentally solves the binary dilemma of "either complete occlusion or uncontrollable" in traditional technologies. Its core advantage lies in the systematic integration and synergistic effect of a series of structural features—"occlusion ring-through-filtration membrane-buffer chamber-circumferential interlacing"—creating a novel, controllable, and stable fluid decompression paradigm. This balloon provides a safe, effective, and controllable third option for clinical use, effectively controlling life-threatening intra-truncal hemorrhage while providing continuous basal perfusion to downstream critical tissues. This significantly extends the surgical safety window and substantially reduces the risk of ischemia-reperfusion injury, demonstrating extremely high clinical application value and commercialization potential.

[0082] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to cover all possible implementations. Those skilled in the art will recognize that various variations and modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations and modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A balloon, characterized in that, include: balloon body (1); The occlusion rings (2) are arranged at intervals on the outer surface of the balloon body (1) along the axial direction of the balloon body (1); each occlusion ring (2) is provided with at least one through hole (21) that penetrates its wall thickness; when the balloon body (1) is inflated, two adjacent occlusion rings (2) and the blood vessel wall (3) together form a buffer cavity (4).

2. The balloon according to claim 1, characterized in that, The through holes (21) on two adjacent blocking rings (2) are staggered from each other in the circumferential direction of the balloon body (1).

3. The balloon according to claim 2, characterized in that, The through holes (21) on two adjacent blocking rings (2) are offset by an angle of 30°-60° in the circumferential direction.

4. The balloon according to claim 3, characterized in that, The through holes (21) on two adjacent blocking rings (2) are offset by 45° in the circumferential direction.

5. The balloon according to claim 1, characterized in that, Multiple occlusion rings (2) are distributed at equal intervals on the outer surface of the balloon body (1).

6. The balloon according to claim 1, characterized in that, The occlusion ring (2) and the balloon body (1) are integrally formed from the same polymer material, or are fixedly connected by bonding or heat sealing.

7. The balloon according to claim 1, characterized in that, The through hole (21) is a variable diameter hole, and the opening on the far end face of the blocking ring (2) is larger than the opening on the near end face; The diameter of the through hole (21) is changed between the large and small openings through a spiral worm tube channel.

8. The balloon according to any one of claims 1 to 7, characterized in that, A filter membrane (22) for limiting blood flow is provided inside the through hole (21).

9. The balloon according to claim 8, characterized in that, The filter membrane (22) has a plurality of micropores (221) for allowing blood to pass through.

10. The balloon according to claim 9, characterized in that, The micropores (221) on the filter membrane (22) are uniformly distributed in a ring array.

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