A progressive dilatation balloon

Abstract

The present invention provides a progressive expansion balloon, comprising: a balloon body; the balloon body comprises a first guide structure area, a functional structure area, and a second guide structure area that are sequentially connected from the proximal end to the distal end; the functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than the diameter of the distal end. Compared with the prior art, the expansion balloon provided by the present invention has an overall tapered structure, which can progressively cut the fibrotic or calcified lesion tissue area through one or more expansions and retractions of the balloon, gradually completing the required expansion, reducing damage to the blood vessels and avoiding tearing; and the two ends of the balloon body are guide structure areas, and the middle is a tapered functional structure area, which is conducive to the gradual advancement of the balloon, making it easier to enter the stenotic lesion and achieve creeping progressive expansion.

Description

Technical Field

[0001] The present invention belongs to the technical field of balloons, and in particular relates to a progressive expansion balloon. Background Art

[0002] Interventional medicine is a method of inserting special catheters or instruments into the lesion site for imaging, diagnosis and treatment under the guidance of medical imaging (X-ray, ultrasound, CT). It is done through percutaneous puncture or through the body's original orifices. It has become the third largest clinical treatment method due to its advantages of less trauma, fewer complications and a wide range of applications (it can be applied to cardiovascular and cerebrovascular diseases, peripheral vascular tumors or non-vascular fields, etc.).

[0003] However, the smooth exterior of conventional balloons can lead to asymmetric force during balloon expansion, causing slippage (commonly known as the "watermelon seed" effect) when treating calcified lesions and in-stent restenosis. This poses significant clinical risks to patients. Furthermore, existing balloon dilatation catheters typically have a cylindrical balloon structure. However, not all blood vessels in the human body are cylindrical. For example, the infrapopliteal artery is tapered from thick to thin. Therefore, when balloon dilatation is needed to treat stenosis, the cylindrical balloon can lead to over-expansion of the vessel, or even tearing.

[0004] Chinese patent publication number CN201135683Y discloses a tapered balloon dilatation catheter with two-end segments at the distal and proximal ends, and a transitional tapered middle section. However, this product lacks separate cutting and anti-slip mechanisms, resulting in poor cutting and dilatation effectiveness in areas with fibrotic or calcified lesions within blood vessels. Furthermore, the balloon is prone to slippage during dilatation, causing vascular damage and delaying surgery, increasing clinical operational difficulty and application risks.

[0005] Chinese patent publication number CN105662668A discloses a conical balloon, including an expandable balloon and a balloon catheter; the balloon is wrapped around the outer circumference of the balloon catheter, and the balloon includes a first conical segment, a second conical segment, and a cylindrical connecting segment connected in sequence. The materials are respectively made of non-compliant material, semi-compliant material, and compliant material. It is made by splicing multiple segmented balloons. The structure and manufacturing process are extremely complex, which not only makes it impossible to effectively guarantee the safety of the device, but also increases the manufacturing cost and the medical burden on patients.

[0006] Chinese patent publication number CN204766984U discloses an anti-slip balloon catheter comprising a balloon, a tubular expansion lumen, and a guidewire on the outside of the balloon for anti-slip performance. However, both the tubular expansion lumen and the guidewire are fixed to the balloon's guide tip, causing hardening of the tip and potentially damaging the vessel wall. Furthermore, the serrated or roughened surface of the guidewire prevents both balloon compliance and anti-slip performance. Furthermore, the round or oval shape of the balloon itself can easily damage or tear the vessel wall due to excessive expansion.

[0007] Chinese patent publication number CN211024712U discloses an anti-slip balloon dilatation catheter comprising a main tube, protrusions, a secondary tube, a connecting rod, and an inflation chamber. The external side of the main tube is connected to the secondary tube via multiple equally spaced connecting rods, forming an inflation chamber between the secondary tube and the main tube. The left end of the secondary tube's outer surface is provided with multiple equally spaced protrusions, and the right end of the secondary tube's outer surface is sheathed with a sealing sleeve. This product utilizes the multiple equally spaced protrusions on the secondary tube's outer surface to provide anti-slip performance, but their securing effect is limited. Furthermore, the balloon lacks a separate cutting mechanism, resulting in poor cutting and dilatation performance that fails to meet clinical needs.

[0008] A Chinese patent with publication number CN202113470U discloses a drug balloon catheter with an anti-slip function, including a catheter, a balloon, multiple ribs and a drug coating. The multiple ribs are provided on the outside of the balloon, which play a cutting and anti-slip role during the balloon expansion process. However, its rib structure is simple and cannot take into account both flexibility and anti-slip functions. At the same time, the balloon body is cylindrical and is very likely to cause excessive expansion damage or tearing of the blood vessel wall during use.

[0009] Chinese patent publication number CN107073247B discloses a balloon that can prevent slippage, including an outer shaft, an inner tube, and an anti-slip element. However, the anti-slip element is a single element, fixed to the outer peripheral surface of the inner tube or formed as a whole with the inner tube, and protrudes outward in the radial direction of the above-mentioned inner tube. When the balloon is expanded, the anti-slip element presses the inner surface of the above-mentioned balloon, and the anti-slip effect is limited; at the same time, the balloon as a whole has an eccentric structure, and the balloon is in a non-uniform and symmetrical state after being folded. During the opening process of the balloon, it is very easy to cause excessive expansion of a local area of ​​the blood vessel, damaging or tearing the blood vessel wall.

[0010] It can be seen that although conical balloons are currently available, due to their own conical structural characteristics, the balloon is very likely to slip after being subjected to force during expansion, causing surgical delays and increasing the risk of clinical application; some conical balloons are made by splicing multiple segmented balloons, resulting in extremely complex structure and manufacturing process, making it impossible to effectively guarantee the safety of the device, and at the same time increasing manufacturing costs and the medical burden on patients. Summary of the Invention

[0011] In view of this, the technical problem to be solved by the present invention is to provide a progressive expansion balloon, which can not only effectively fix and prevent slipping during balloon expansion, but also effectively reduce damage to blood vessels and avoid tearing.

[0012] The present invention provides a progressive expansion balloon, comprising:

[0013] Balloon body;

[0014] The balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are connected in sequence from the proximal end to the distal end;

[0015] The functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than the diameter of the distal end.

[0016] Preferably, it further includes an anti-slip structure area; the first guide structure area is connected to the functional structure area through the anti-slip structure area;

[0017] The outer surface of the anti-slip structure area is provided with an anti-slip structure; the anti-slip structure is a raised anti-slip structure or an elastic anti-slip structure provided on the outer surface of the anti-slip structure area.

[0018] Preferably, the anti-slip structural area is cylindrical; the outer diameter of the anti-slip structural area is 1.0 to 20 mm; and the length of the anti-slip structural area is 0.1 to 50 mm.

[0019] Preferably, the height of the raised anti-slip structure is 0.01 to 1 mm;

[0020] The elastic anti-slip structure includes a gap structure; the gap of the gap structure in the elastic anti-slip structure is 0.002-1 mm.

[0021] Preferably, a cutting structure is provided on the outer surface of the functional structure area in the longitudinal direction; the cutting structure is a raised cutting structure or an elastic cutting structure provided on the outer surface of the functional structure area.

[0022] Preferably, the height of the raised cutting structure is 0.01 to 1 mm; the length of the elastic cutting structure is 2 to 150 mm, the height is 0.1 to 2 mm, and the width is 0.05 to 1 mm.

[0023] Preferably, the elastic cutting structure includes a gap structure; the gap of the gap structure in the elastic cutting structure is 0 to 0.3 mm.

[0024] Preferably, the elastic cutting structure further includes a second gap structure, and the second gap structure is arranged at the proximal end of the functional structure area; the gap of the second gap structure is 0.002 to 1 mm.

[0025] Preferably, the cone angle is 0.1° to 45°; and the length of the functional structure area is 0.5 to 150 mm.

[0026] Preferably, the first guiding structure area and the second guiding structure area are both conical structures; the cone angles of the first guiding structure area and the second guiding structure area are independently 10° to 85°; the lengths of the first guiding structure area and the second guiding structure area are independently 0.5 to 10 mm.

[0027] The present invention provides a progressive expansion balloon, comprising: a balloon body; the balloon body comprises a first guide structure area, a functional structure area, and a second guide structure area that are sequentially connected from the proximal end to the distal end; the functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than the diameter of the distal end. Compared with the prior art, the expansion balloon provided by the present invention has an overall tapered structure, which can progressively cut the fibrotic or calcified lesion tissue area through one or more expansions and retractions of the balloon, gradually completing the required expansion, reducing damage to the blood vessels and avoiding tearing; and the two ends of the balloon body are guide structure areas, and the middle is a tapered functional structure area, which is conducive to the gradual advancement of the balloon, making it easier to enter the stenotic lesion and achieve creeping progressive expansion.

[0028] Furthermore, the outer surface of the functional structural area is provided with a cutting structure, which can provide effective cutting force during the balloon expansion process, thereby facilitating the expansion of the balloon to fibrotic or calcified pathological tissues.

[0029] Furthermore, an anti-slip structural area is provided at the proximal end, which has a good positioning effect during the balloon expansion process and prevents the "watermelon seed" effect of the conical balloon in cutting fibrotic stenosis lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A schematic structural diagram of the progressive expansion balloon provided by the present invention;

[0031] Figure 2 A schematic structural diagram of the progressive expansion balloon provided by the present invention;

[0032] Figure 3 Schematic diagram of the structure of vascular fibrosis or calcification lesion tissue;

[0033] Figure 4 A schematic diagram of the progressive expansion balloon provided by the present invention in vascular fibrosis or calcification lesions;

[0034] Figure 5 A schematic structural diagram of the progressive expansion balloon provided by the present invention;

[0035] Figure 6A schematic structural diagram of the progressive expansion balloon provided by the present invention;

[0036] Figure 7 A schematic structural diagram of the progressive expansion balloon provided by the present invention;

[0037] Figure 8 A schematic diagram of the elastic structure provided by the present invention;

[0038] Figure 9 A schematic diagram of the elastic structure provided by the present invention;

[0039] Figure 10 A schematic diagram of the cutting process of the progressive expansion balloon provided by the present invention;

[0040] Figure 11 A schematic diagram of the cutting process of the progressive expansion balloon provided by the present invention;

[0041] Figure 12 A schematic diagram of the cutting process of the progressive expansion balloon provided by the present invention;

[0042] Figure 13 A schematic diagram of the cutting process of the progressive expansion balloon provided by the present invention;

[0043] Figure 14 This is a schematic cross-sectional view of the progressive expansion balloon provided by the present invention after retraction;

[0044] Figure 15 Schematic diagram of the ceramic ring vascular calcification lesion tissue model. DETAILED DESCRIPTION

[0045] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0046] The present invention provides a progressive expansion balloon, comprising: a balloon body; the balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are connected in sequence from the proximal end to the distal end; the functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is greater than the diameter of the distal end.

[0047] See also Figure 1 and Figure 2 , Figure 1 and Figure 2This is a schematic structural diagram of the progressive expansion balloon provided by the present invention, wherein A is an overall distal view, B is a side view, 100 is the balloon body, 200 is the cutting structure, 110 is the functional structure area, 120 is the anti-slip structure area, and 130 is the guide structure area.

[0048] The balloon provided by the present invention adopts a progressive structure, which gradually expands the fibrotic or calcified pathological tissue area within the blood vessel through multiple pressurization and advancement of the balloon, thereby preventing damage or tearing of the blood vessel wall caused by excessive expansion during surgery.

[0049] See also Figure 3 and Figure 4 , Figure 3 Schematic diagram of the structure of vascular fibrosis or calcification diseased tissue, wherein the left figure is a longitudinal cross-sectional schematic diagram, the right figure is a cross-sectional schematic diagram, 300 is a vascular fibrosis or calcification diseased tissue model, 301 is a normal tissue area of ​​the vascular model, and 302 is a vascular fibrosis or calcification diseased tissue area; Figure 4 Schematic diagram of a progressive expansion balloon in vascular fibrosis or calcification pathological tissue, wherein 100 is the balloon body, 201 is the elastic cutting structure, 202 is the elastic anti-slip structure, 301 is the normal tissue area of ​​the vascular model, and 302 is the vascular fibrosis or calcification pathological tissue area.

[0050] According to the present invention, the balloon body is preferably a nylon balloon body or a nylon plus segmented polyetheramide balloon body; the balloon body is preferably made of nylon (PA) or nylon (PA) plus segmented polyetheramide (PEBAX) extruded into a single-lumen tube as the balloon body raw material, and then hot blow molded on a balloon molding machine containing a convex mold.

[0051] The balloon body includes a first guide structure area, a functional structure area and a second guide structure area which are connected in sequence from the proximal end to the distal end. The functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than the diameter of the distal end; the outer diameter of the proximal end of the functional structure area is preferably 1.0-20 mm, more preferably 1.0-12 mm, more preferably 1.5-10 mm, more preferably 2-8 mm, and most preferably 2.5-7 mm; the cone angle of the functional structure area is preferably 0.1°-45°, more preferably 1°-40°, more preferably 1°-35°, more preferably 1°-30°, more preferably 3°-25°, and most preferably 3°-20°; in the embodiment provided by the present invention, the cone angle of the functional structure area is specifically 3°, 5° or 20°; the length of the functional structure area is preferably 0.5-150 mm, more preferably 5-150 mm, more preferably 10-120 mm, and most preferably 30-120 mm; in the embodiment provided by the present invention, the length of the functional structure area is specifically 100 mm, 30 mm, 50 mm or 120 mm.

[0052] According to the present invention, the outer surface of the functional structure area is preferably provided with a cutting structure in the longitudinal direction; in order to achieve progressive cutting, when the functional structure area is in a contracted state, the cutting structure is preferably located outside the functional structure area, that is, not wrapped by the functional structure area, so that the balloon can achieve the cutting function in an expanded state or a gradually expanded state; the cutting structure has a good mechanical structure that is conducive to the expansion and cutting of fibrotic or calcified diseased tissue areas; the number of the cutting structures is preferably 1 to 10, more preferably 1 to 8; when the number of the cutting structures is greater than 1, it is preferably evenly distributed on the surface of the functional structure area. surface; the cutting structure is preferably a raised cutting structure or an elastic cutting structure provided on the outer surface of the functional structure area; the raised cutting structure can be a continuous or discontinuous structure; when the raised cutting structure is a discontinuous structure, it is preferred that a raised cutting structure is provided on the proximal outer surface of the functional structure area, and at this time the raised cutting structure can simultaneously play the role of fixing and anti-slip and cutting; the cross-section of the raised cutting structure is preferably triangular or circular; the height of the raised cutting structure is preferably 0.01 to 1 mm, more preferably 0.05 to 1 mm, and even more preferably 0.1 to 1 mm, The most preferred range is 0.3-0.4 mm; the width of the raised cutting structure is preferably 0.05-1 mm, more preferably 0.1-1 mm, and even more preferably 0.3-0.4 mm; the material of the elastic cutting structure is preferably stainless steel, nickel-iron alloy, tungsten, platinum-tungsten alloy or high-strength polymer material; the elastic cutting structure is preferably wound with a single wire or multiple wires, or is an elastic cutting structure cut from a tube; the length of the elastic cutting structure is preferably 2-150 mm, more preferably 5-150 mm, even more preferably 10-130 mm, and most preferably 30-130 mm m; the height of the elastic structure is preferably 0.1-2 mm, more preferably 0.2-1.5 mm, more preferably 0.2-1 mm, more preferably 0.3-0.8 mm, and most preferably 0.3-0.5 mm; the width of the elastic structure is preferably 0.05-1 mm, more preferably 0.1-1 mm, more preferably 0.3-1 mm, and most preferably 0.3-0.6 mm; the cross-section of the elastic cutting structure is preferably an inner circle, a semicircle, an ellipse or a polygon; the number of sides of the polygon is preferably 3-10, more preferably 3-8, and more preferably 3-5.The elastic cutting structure preferably has a gap structure; the gap of the gap structure is preferably 0-0.3mm, more preferably 0-0.15mm, more preferably 0.005-0.15mm, more preferably 0.005-0.1mm, most preferably 0.005-0.05mm; in the embodiment provided by the present invention, the gap of the gap structure in the elastic cutting structure is specifically 0.02 or 0.03mm; the length of the gap structure in the elastic cutting structure is preferably 0.5-150mm, more preferably 2-145mm, more preferably 5-140mm, more preferably 10-130mm, most preferably 26-126mm; in the present invention, the elastic cutting structure preferably also includes a second gap structure, the second gap structure is arranged at the proximal end of the functional structure area, and the gap of the second gap structure is larger than the gap of the gap structure; the gap of the second gap structure is preferably 0.002-1mm, more preferably 0.005-0.8mm, more preferably 0.01-0.5mm, more preferably 0.01-0.4 mm, most preferably 0.02-0.3 mm; in the embodiment provided by the present invention, the gap of the second gap structure is specifically 0.08 mm or 0.2 mm; the length of the second gap structure is preferably 0.1-50 mm, more preferably 0.5-45 mm, more preferably 1-40 mm, more preferably 1-30 mm, more preferably 2-20 mm, more preferably 2-15 mm, and most preferably 2-10 mm; in the embodiment provided by the present invention, the length of the second gap structure is specifically 6 mm or 7 mm; the length ratio of the second gap structure to the gap structure is preferably 1:(0.5-50), more preferably 1:(1-30), more preferably 1:(2-25), and most preferably 1:(3-20); in the embodiment provided by the present invention, the length ratio of the second gap structure to the gap structure is specifically 1:3 or 1:14; the gap of the second gap structure is smaller than the gap structure located at the maximum conical diameter of the functional structure area, which can play a role in fixing and anti-slip, and the increase in the gap can improve its flexibility and avoid damage to the blood vessel wall.

[0053] The progressive expansion balloon provided by the present invention preferably further includes an anti-slip structural area; the first guiding structural area is connected to the functional structural area through the anti-slip structural area; Figure 5 , Figure 5Schematic diagram of the structure of the progressive expansion balloon provided by the present invention, wherein A is an overall distal view, B is a side view, 110 is a functional structure area, 120 is an anti-slip structure area, and 130 is a guide structure area; the anti-slip structure area and the functional structure area are preferably integrated; the anti-slip structure area is preferably cylindrical, that is, the inner diameters of the two ends of the anti-slip structure area from the proximal end to the distal end are the same or similar; the outer diameter of the anti-slip structure area is preferably 1.0 to 20 mm, more preferably 1.0 to 12 mm, more preferably 1.5 to 10 mm, more preferably 2 to 8 mm, and most preferably 2.5 to 7 The length of the anti-slip structural area is preferably 0.1 to 50 mm, more preferably 0.5 to 40 mm, more preferably 1 to 30 mm, more preferably 1 to 25 mm, more preferably 1 to 20 mm, and most preferably 2 to 12 mm; the ratio of the length of the anti-slip structural area to the length of the functional structural area is preferably 1:(0.5 to 50), more preferably 1:(1 to 30), more preferably 1:(2 to 25), and most preferably 1:(3 to 20); the outer surface of the anti-slip structural area is provided with an anti-slip structure; the anti-slip structure can effectively fix the balloon during expansion. Figure 6 and Figure 7 , Figure 6 and Figure 7Schematic diagram of the structure of the progressive expansion balloon provided by the present invention, wherein 110 is a functional structure area, 111 and 201 are cutting structures, 120 is an anti-slip structure area, 121 is an anti-slip structure, and 130 is a guide structure area; the anti-slip structure is preferably a raised anti-slip structure or an elastic anti-slip structure provided on the outer surface of the anti-slip structure area; the height of the raised anti-slip structure is preferably 0.05 to 5 mm, more preferably 0.1 to 3 mm, more preferably 0.1 to 2 mm, more preferably 0.3 to 1 mm, and most preferably 0.3 to 0.8 mm; the raised anti-slip structure is preferably 0.05 to 5 mm, more preferably 0.1 to 3 mm, more preferably 0.1 to 2 mm, more preferably 0.3 to 1 mm, and most preferably 0.3 to 0.8 mm; The anti-slip structure can be a convex point or a ring-shaped structure; when the raised anti-slip structure is a convex point, the diameter of the convex point is preferably 0.1 to 3 mm, more preferably 0.5 to 2.5 mm, and more preferably 0.5 to 2 mm; in the embodiment provided by the present invention, the diameter of the convex point is specifically 1 mm; when the raised anti-slip structure is a ring-shaped structure, the number of the convex point is preferably 1 to 5, more preferably 1 to 3, and more preferably 1 to 2; the width of the ring-shaped structure is preferably 0.1 to 3 mm, more preferably 0.1 to 2 mm, more preferably 0.1 to 1.5 mm, and most preferably 0. 1~1mm; In the embodiment provided by the present invention, the width of the annular structure is specifically 0.4mm or 0.6mm; When the anti-slip structure is an elastic anti-slip structure, it is preferably connected to the elastic cutting structure of the cutting wire; The elastic anti-slip structure preferably includes a gap structure; The gap of the gap structure in the elastic anti-slip structure is preferably 0.002~1mm, more preferably 0.005~0.8mm, more preferably 0.01~0.5mm, more preferably 0.1~0.5mm, most preferably 0.1~0.3mm; The length of the gap structure The thickness is preferably 0.1-50 mm, more preferably 0.5-45 mm, even more preferably 1-40 mm, even more preferably 5-30 mm, even more preferably 5-20 mm, even more preferably 5-15 mm, and most preferably 5-10 mm; the material of the elastic anti-slip structure is preferably stainless steel, nickel-iron alloy, tungsten, platinum-tungsten alloy or high-strength polymer material; the elastic anti-slip structure is preferably wound with a single wire or multiple wires, or is an elastic cut structure cut from a tube; the cross-section of the elastic anti-slip structure is preferably an inner circle, a semicircle, an ellipse or a polygon.

[0054] In the present invention, it is most preferred that the cutting structure provided on the outer surface of the functional structure area is an elastic cutting structure, and the anti-slip structure provided on the outer surface of the anti-slip structure area is an elastic anti-slip structure. The two are integrated, that is, both are elastic structures. The elastic structure can be divided into an elastic cutting structure area and an elastic anti-slip structure area by the difference in the gap structure included in the elastic structure and the size of the elastic structure, see Figure 8 and Figure 9 , Figure 8 and Figure 9It is a schematic diagram of the elastic structure, wherein 201 is the elastic cutting structure, 202 is the elastic anti-slip structure, a is the gap value of the elastic cutting structure, and b is the gap value of the elastic anti-slip structure. The cutting structure has an excellent force-gathering function, which is beneficial for cutting and expanding intravascular fibrotic or calcified diseased tissue; the anti-slip cutting function structure has a good anti-slip function to prevent slippage during balloon expansion.

[0055] The two ends of the balloon body in the progressive expansion balloon provided by the present invention are respectively the first guide structure area and the second guide structure area, which are connected to the catheter through the first guide structure area and connected to the terminal tube through the second guide structure area. The guide structure areas at both ends can provide guidance for the delivery of the balloon. The first guide structure area and the second guide structure area are preferably conical structures; the cone angles of the first guide structure area and the second guide structure area are each independently preferably 10° to 85°, more preferably 20° to 80°, more preferably 30° to 70°, and most preferably 35° to 60°; in the embodiment provided by the present invention, the cone angles of the first guide structure area and the second guide structure area are each independently specifically 35°, 40°, 50° or 60°; the lengths of the first guide structure area and the second guide structure area are each independently preferably 0.5 to 10 mm, more preferably 1 to 6 mm, and more preferably 35° to 60°. It is preferably 1 to 4 mm, most preferably 1 to 3 mm; the length ratio of the first guiding structure area or the second guiding structure area to the functional structure area is preferably (1 to 10): (20 to 200), more preferably (1 to 8): (20 to 180), further preferably (1.5 to 6): (20 to 180), and most preferably (1.5 to 5): (20 to 150); in the embodiments provided by the present invention, the length ratio of the first guiding structure area or the second guiding structure area to the functional structure area is preferably 1:50, 1.5:30, 1.6:30, 3:50, 5:50 or 3:120.

[0056] Specifically, in the embodiment provided by the present invention, the balloon body of the progressive expansion balloon is composed of a first guide structure area, a functional structure area and a second guide structure area which are connected in sequence; the outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction; the cutting structure is an elastic cutting structure; the elastic cutting structure includes a gap structure and a second gap structure; under this structure, the second gap structure also plays an anti-slip role.

[0057] In another embodiment provided by the present invention, the balloon body of the progressive expansion balloon is composed of a first guide structure area, an anti-slip structure area, a functional structure area and a second guide structure area that are connected in sequence from the proximal end to the distal end; the outer surface of the anti-slip structure area is a smooth structure; the outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction; the cutting structure is an elastic cutting structure; the elastic cutting structure includes a gap structure and a second gap structure; under this structure, the second gap structure also plays an anti-slip role.

[0058] In another embodiment provided by the present invention, the balloon body of the progressive expansion balloon is composed of a first guide structure area, an anti-slip structure area, a functional structure area and a second guide structure area that are connected in sequence from the proximal end to the distal end; the outer surface of the anti-slip structure area is a smooth structure; the outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction; the cutting structure is an elastic cutting structure; the elastic cutting structure includes a gap structure and a second gap structure; under this structure, the second gap structure also plays an anti-slip role.

[0059] In another embodiment provided by the present invention, the balloon body of the progressive expansion balloon is composed of a first guide structure area, an anti-slip structure area, a functional structure area and a second guide structure area that are connected in sequence from the proximal end to the distal end; the outer surface of the anti-slip structure area is provided with an anti-slip structure; the outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction; under this structure, since the anti-slip structure area already has an anti-slip structure, the cutting structure can be a raised cutting structure or an elastic cutting structure; the elastic cutting structure can include only a gap structure, or can include a gap structure and a second gap structure at the same time.

[0060] The expansion balloon provided by the present invention has an overall conical structure. Through one or more expansion and retraction of the balloon, the fibrotic or calcified lesion tissue area can be progressively cut to gradually complete the required expansion, thereby reducing damage to the blood vessels and avoiding tearing. In addition, the two ends of the balloon body are guide structure areas, and the middle is a conical functional structure area, which is conducive to the gradual advancement of the balloon and makes it easier to enter the stenotic lesion to achieve creeping progressive expansion.

[0061] Furthermore, the outer surface of the functional structural area is provided with a cutting structure, which can provide effective cutting force during the balloon expansion process, thereby facilitating the expansion of the balloon to fibrotic or calcified pathological tissues.

[0062] Furthermore, an anti-slip structural area is provided at the proximal end, which has a good positioning effect during the balloon expansion process and prevents the "watermelon seed" effect of the conical balloon in cutting fibrotic stenosis lesions.

[0063] Most preferably, the progressive dilation balloon provided by the present invention includes an anti-slip region for excellent anti-slip and fixation, and a functional structural region that provides excellent dilation and cutting effects. Through multiple, progressive cuts, the balloon effectively dilates areas of fibrotic or calcified tissue, minimizing damage to blood vessels and preventing vascular tears.

[0064] The specific method is as follows: first, the progressive expansion balloon is delivered to the predetermined location and then pressurized. During the pressurization process, the anti-slip area first contacts and fixes the fibrotic or calcified lesion tissue of the blood vessel to prevent slippage during the balloon expansion process. As the balloon pressure increases, the conical balloon expansion area gradually cuts and expands the fibrotic or calcified lesion area in contact. After completion, the balloon pressure is released to negative pressure, and the balloon is further advanced to the predetermined location and the pressurization process is repeated to cut and expand the fibrotic or calcified lesion area. This process is repeated multiple times according to actual needs to complete the cutting and expansion of the desired fibrotic or calcified lesion area. Figures 10 to 15 , Figures 10 to 13 Schematic diagram of the cutting process of the progressive expansion balloon provided by the present invention, wherein 100 is the balloon body, 201 is the elastic cutting structure, 202 is the elastic anti-slip structure, 301 is the normal tissue area of ​​the vascular model, and 302 is the vascular fibrosis or calcification pathological tissue area; Figure 14 This is a schematic cross-sectional view of the progressive expansion balloon provided by the present invention after retraction, wherein 100 is the balloon body and 200 is the cutting structure; Figure 15 Schematic diagram of the ceramic ring vascular calcification lesion tissue model.

[0065] To further illustrate the present invention, a progressive expansion balloon provided by the present invention is described in detail below with reference to examples.

[0066] The reagents used in the following examples are all commercially available.

[0067] Example 1

[0068] like Figure 2 As shown, this embodiment provides a progressive cutting and dilation balloon, which is composed of a balloon body 100 and a cutting function mechanism 200; Figure 5 The balloon body 100 is composed of a guide structure 130 with a taper of 40° and a length of 2mm; an anti-slip structure 120 with an outer diameter of 6mm and a length of 10mm; and a functional structure area 110 with a taper of 20° and a length of 100mm. Four elastic structures are evenly adhered to the outside. Figure 8 The elastic structure is made of nickel-titanium filaments with an outer diameter of 0.05mm, a length of 105mm, a height of 0.5mm, and a width of 0.4mm. The gap at the cutting structure of the elastic structure is 0.02mm and the length is 98mm; the gap at the anti-slip structure of the elastic structure is 0.2mm and the length is 7mm.

[0069] First, push the progressive cutting and dilation balloon to the calcified lesion tissue with a lesion length of 150 mm. Figure 3 The desired target position is set on the inside, and the pressure of the balloon is gradually increased to 18 atmospheres. The cutting wire anti-slip functional structure 202 first contacts the calcified lesion tissue 302 and the fixing force is gradually strengthened as the balloon pressure increases. At the same time, the cutting structure 201 along the functional structure area 110 gradually cuts and expands the calcified lesion tissue 302 along the tapered direction of the balloon. Figure 10 After the balloon is completed, the pressure is released to negative pressure, and then the balloon is pushed forward to the predetermined position. Figure 11 Repeated compression process cuts and expands the calcified lesion tissue area. Figure 12 Repeat 8 times to complete the cutting and expansion of all calcified lesion tissue areas, and finally the calcified lesion tissue in the blood vessel is completely opened. Figure 13 .

[0070] During the above process, the balloon cutting process was stable without sliding. At the same time, due to the use of a tapered balloon with a cutting wire and a progressive expansion method, the required expansion pressure was reduced by more than 30% compared with ordinary balloons, and no damage or rupture of the blood vessel wall was observed during the process.

[0071] Example 2

[0072] like Figure 2 As shown, this embodiment provides a progressive cutting and dilation balloon, which is composed of a balloon body 100 and a cutting function mechanism 200; Figure 1 The balloon body 100 shown is composed of a guide structure 130 with a distal taper of 60° and a length of 1.5mm, a proximal taper of 50° and a length of 1.6mm, and a functional structure area 110 with a taper of 3° and a length of 30mm. The outer diameter of the proximal end of the functional structure area is 10mm.

[0073] Four elastic structures are evenly adhered to the outside. Figure 2 The elastic structure is formed by laser cutting of a nickel-titanium triangular tube, with a length of 26 mm, a height of 0.3 mm, and a width of 0.3 mm. The cutting structure gap of the elastic structure is 0.02 mm and a length of 20 mm. The second gap structure gap of the elastic structure is 0.08 mm and a length of 6 mm. The cross section of the cutting structure 111 of the balloon body after folding of the present invention is as follows: Figure 14 , and its cutting structure 200 is located outside the balloon body 100.

[0074] First, the progressive cutting and dilation balloon is pushed into the fibrotic tissue with a lesion length of 24 mm, and then the pressure of the balloon is gradually increased to 25 atmospheres. The anti-slip functional structure 202 of the elastic structure first contacts the fibrotic tissue 302 and the fixing force is gradually strengthened as the balloon pressure increases. At the same time, the cutting wire 201 along the balloon cutting functional area 110 gradually cuts and expands the fibrotic tissue 302 along the balloon taper direction. Figure 10 Because the lesion length is short, the cutting functional area is long, and the taper is small, the fibrotic or calcified lesion tissue area in the blood vessel is completely opened after the cutting and expansion is completed. Figure 13 .

[0075] During the above process, the balloon cutting process was stable without slipping, and no damage or rupture of the blood vessel wall was observed during the process.

[0076] Example 3

[0077] like Figure 2 As shown, this embodiment provides a progressive cutting and dilation balloon, which is composed of a balloon body 100 and a cutting function mechanism 200; Figure 6 As shown, the balloon body 100 comprises a guide structure region 130 with a distal taper of 50° and a length of 3mm, a proximal taper of 35° and a length of 5mm, an anti-slip structure region 120 with an outer diameter of 4mm and a length of 2mm, and a functional structure region 110 with a taper of 5° and a length of 50mm. Two anti-slip structures, one with a width of 0.4mm and a height of 0.3mm, and one with a width of 0.6mm and a height of 0.4mm, are evenly distributed on the outer side of the anti-slip structure 120.

[0078] First, the progressive cutting and dilation balloon is pushed into the fibrotic tissue with a lesion length of 65 mm, and then the pressure of the balloon is gradually increased to 20 atmospheres. The anti-slip structure 121 first contacts the fibrotic tissue 302 and the fixing force is gradually strengthened as the balloon pressure increases. At the same time, the cutting structure 111 along the functional structure area 110 gradually cuts and expands the fibrotic tissue 302 along the tapered direction of the balloon. Figure 10 After the balloon is completed, the pressure is released to negative pressure, and then the balloon is pushed forward to the predetermined position. Figure 11 Repeated compression process cuts and expands the fibrotic tissue area. Figure 12 Repeat this process 4 times to complete the cutting and expansion of all fibrotic tissue areas, and finally the fibrotic tissue in the blood vessels is completely opened. Figure 13 .

[0079] In the above process, the balloon cutting process during the expansion process of the present invention is stable and there is no sliding phenomenon. At the same time, due to the use of a tapered balloon with a cutting wire and a progressive expansion method, no blood vessel wall damage or rupture is observed during the process.

[0080] Example 4

[0081] like Figure 2 As shown, this embodiment provides a progressive cutting and dilatation balloon, which consists of a balloon body 100 and a cutting functional mechanism 200. The balloon body 100 consists of a guide structure area 130 with a taper of 60° and a length of 3mm, an anti-slip structure area 120 with an outer diameter of 7mm and a length of 12mm, and a functional structure area 110 with a taper of 3° and a length of 120mm. 50 anti-slip bumps with a diameter of 1mm and a height of 0.8mm are evenly distributed on the outside of the anti-slip structure area 120, and three cutting wires are evenly adhered to the outside of the balloon. Figure 7 As shown, the cutting wire is made of nickel-titanium triangular tube by laser cutting, with a length of 136mm, a height of 0.4mm, and a width of 0.45mm. The cutting wire only has a cutting structure, a gap of 0.03mm, and a length of 116mm. The cross section of the cutting structure 111 of the balloon body after folding the present invention is as shown Figure 14 , and its cutting structure 200 is located outside the balloon body 100.

[0082] The progressive expansion balloon provided in Example 4 of the present invention (the cone structure angle and the ratio of each area are the same, but the length of each area is different according to the maximum outer diameter and the total length of the balloon) is compared with the Mustang TM , put in the corresponding vascular calcification lesion tissue model, specifically the ceramic ring Figure 15 The cutting and expansion test was carried out and the cutting and expansion effect of the progressive expansion balloon provided by the present invention was significantly better than that of the control group Mustang TM , as shown in Table 1 below.

[0083] Table 1 Cutting and expansion test data comparison table

[0084]

Claims

1. A progressive dilatation balloon, characterized in that: include: Balloon body; The balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are connected in sequence from the proximal end to the distal end; The first guiding structure region and the second guiding structure region are both tapered structures; the tapered angles of the first guiding structure region and the second guiding structure region are independently 10° to 85°; the lengths of the first guiding structure region and the second guiding structure region are independently 0.5 to 10 mm; The functional structure area is tapered from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than the diameter of the distal end; It also includes an anti-slip structure area; the first guide structure area is connected to the functional structure area through the anti-slip structure area; The outer surface of the anti-slip structural area is provided with an anti-slip structure; the anti-slip structure is a raised anti-slip structure or an elastic anti-slip structure provided on the outer surface of the anti-slip structural area; the anti-slip structural area is cylindrical; The outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction; the cutting structure is a convex cutting structure or an elastic cutting structure provided on the outer surface of the functional structure area; When the functional structure area is in a contracted state, the cutting structure is located outside the functional structure area; The protruding cutting structure is a discontinuous structure, and is provided on the outer surface of the proximal end of the functional structure area; the cross section of the protruding cutting structure is triangular or circular; The elastic cutting structure includes a gap structure and a second gap structure. The second gap structure is arranged at the proximal end of the functional structure area, and the gap of the second gap structure is larger than the gap of the gap structure. The length ratio of the second gap structure to the gap structure is 1: (3~20).

2. The progressive dilatation balloon according to claim 1, characterized in that: The outer diameter of the anti-slip structure area is 1.0-20 mm; the length of the anti-slip structure area is 0.1-50 mm.

3. The progressive dilatation balloon according to claim 1, characterized in that: The height of the raised anti-slip structure is 0.01-1 mm; The elastic anti-slip structure includes a gap structure; the gap of the gap structure in the elastic anti-slip structure is 0.002-1 mm.

4. The progressive dilatation balloon according to claim 1, characterized in that: The height of the raised cutting structure is 0.01-1 mm; the length of the elastic cutting structure is 2-150 mm, the height is 0.1-2 mm, and the width is 0.05-1 mm.

5. The progressive dilatation balloon according to claim 1, characterized in that: The gap structure in the elastic cutting structure has a gap of 0-0.3 mm.

6. The progressive dilatation balloon according to claim 1, characterized in that: The gap of the second gap structure is 0.002-1 mm.

7. The progressive dilatation balloon according to claim 1, characterized in that: The cone angle of the cone is 0.1° to 45°; the length of the functional structure area is 0.5 to 150 mm.

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