Background
The interventional medicine is that under the guidance of image medicine (X-ray, ultrasound and CT), a specially-made catheter or instrument is inserted into a lesion site for radiography, diagnosis and treatment through a percutaneous puncture way or through an original duct of a human body, and the interventional medicine has become a third largest clinical treatment means due to the advantages of small trauma, less complications and wide application range (being applicable to the fields of cardiovascular and cerebrovascular, peripheral vascular tumor or non-vascular, etc.).
However, for the common expansion balloon, the outer part of the balloon is very smooth, and when the calcified lesions and the restenosis lesions in the stent are treated, the balloon can slide commonly called as a watermelon seed effect due to the fact that stress is possibly asymmetric when the balloon is expanded, so that great clinical risks are brought to patients. Meanwhile, in the existing balloon dilation catheter, the balloon part is generally a cylindrical mechanism, but blood vessels on a human body are not all cylindrical, for example, blood vessels of a below-knee artery are conical from thick to thin, so that when the balloon dilation is required for vascular stenosis, the cylindrical balloon can cause excessive dilation of the blood vessels and even tearing.
Chinese patent publication No. CN201135683Y discloses a tapered balloon dilation catheter, the distal end of the balloon and the proximal end of the balloon are of two-end section structure, the middle section of the balloon is of transition tapered structure. But the product has no independent cutting function mechanism and anti-slip function mechanism, has poor cutting and expanding effects on the blood vessel fibrosis or calcified lesion tissue region in an operating room, is easy to slip in the balloon expanding process, causes vascular injury and delayed operation, and increases clinical operation difficulty and application risk.
The Chinese patent with the publication number of CN105662668A discloses a conical balloon, which comprises an inflatable balloon and a balloon catheter, wherein the balloon is wrapped on the periphery of the balloon catheter, the balloon comprises a first conical section, a second conical section and a cylindrical connecting section which are sequentially connected, the materials are respectively made of non-compliant materials, semi-compliant materials and compliant materials, the conical balloon is formed by splicing a plurality of segmented balloons, the structure and the manufacturing process are complex, the safety of the instrument cannot be effectively ensured, and the manufacturing cost and the medical burden of a patient are increased.
Chinese patent publication No. CN204766984U discloses an anti-skid balloon catheter, which comprises a balloon and a tubular expansion lumen, and a guide wire is arranged outside the balloon for anti-skid. However, the tubular expansion lumen structure and the guide wire are both fixed on the balloon guiding tip, so that the balloon guiding tip is hardened to damage the vessel wall, and the surface of the guide wire is serrated or roughened, so that the balloon flexibility and the anti-skid function cannot be considered, and meanwhile, the balloon body is quite easy to cause transitional expansion damage or tearing of the vessel wall when in circular or elliptic use.
The Chinese patent with the publication number of CN211024712U discloses an anti-skid balloon dilation catheter, which comprises a main pipe, protruding points, auxiliary pipes, connecting rods and an inflation cavity, wherein the outer side of the main pipe is connected with the auxiliary pipes through a plurality of connecting rods distributed at equal intervals, the auxiliary pipes and the main pipe form the inflation cavity, meanwhile, the left end of the outer surface of the auxiliary pipes is provided with a plurality of protruding points distributed at equal intervals, and the right end of the outer surface of the auxiliary pipes is sleeved with a sealing sleeve. The product is anti-skidding through a plurality of equidistance bump that the accessory pipe surface set up, but its fixed effect is limited, and this sacculus does not set up solitary cutting function mechanism simultaneously, and the cutting expansion effect is poor can't satisfy clinical actual demand.
The Chinese patent with the publication number of CN202113470U discloses a drug balloon catheter with an anti-slipping function, which comprises a catheter, a balloon, a plurality of tendons and a drug coating, wherein the tendons are arranged on the outer side of the balloon, and the balloon has the cutting and anti-slipping functions in the balloon expanding process, but the tendons are simple in structure and cannot give consideration to the flexibility and the anti-slipping function, and meanwhile, the balloon body is cylindrical and is extremely easy to cause transitional expansion damage or tearing of the vessel wall in use.
The chinese patent publication No. CN107073247B discloses a balloon capable of preventing the balloon from being slipped, comprising an outer shaft, an inner tube and an anti-slip element, wherein the anti-slip element is a single element, is fixed on the outer circumferential surface of the inner tube or integrally formed with the inner tube, protrudes outward in the radial direction of the inner tube, has limited anti-slip effect when the balloon is expanded, presses the inner surface of the balloon, and has an eccentric structure, and is in an uneven symmetrical state after being folded, so that the balloon is very easy to cause excessive expansion of a local area of a blood vessel, damage or tear the wall of the blood vessel in the opening process of the balloon.
Therefore, the existing conical balloon has the advantages that the balloon is easy to slip after being stressed in the expansion process due to the self conical structural characteristics, the operation is delayed, the clinical application risk is increased, and the partial conical balloon is formed by splicing a plurality of segmented balloons, so that the structure and the manufacturing process are extremely complex, the safety of the instrument cannot be effectively ensured, and the manufacturing cost and the medical burden of a patient are increased.
Disclosure of Invention
In view of the above, 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 when the balloon is expanded, but also effectively reduce the damage to the blood vessel and avoid tearing.
The invention provides a progressive dilation 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 sequentially communicated 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 that of the distal end.
Preferably, the device further comprises an anti-skid structure area, wherein the first guide structure area is communicated with the functional structure area through the anti-skid structure area;
The outer surface of the anti-skid structure area is provided with an anti-skid structure, and the anti-skid structure is a convex anti-skid structure or an elastic anti-skid structure arranged on the outer surface of the anti-skid structure area.
Preferably, the anti-skid structure area is cylindrical, the outer diameter of the anti-skid structure area is 1.0-20 mm, and the length of the anti-skid structure area is 0.1-50 mm.
Preferably, the height of the raised anti-skid structure is 0.01-1 mm;
The elastic anti-slip structure comprises a gap structure, wherein the gap of the gap structure in the elastic anti-slip structure is 0.002-1 mm.
Preferably, the outer surface of the functional structure area is provided with a cutting structure along the longitudinal direction, and the cutting structure is a convex cutting structure or an elastic cutting structure arranged on the outer surface of the functional structure area.
Preferably, the height of the protruding 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.
Preferably, the elastic cutting structure comprises a gap structure, and the gap of the gap structure in the elastic cutting structure is 0-0.3 mm.
Preferably, the elastic cutting structure further comprises 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 0.002-1 mm.
Preferably, the taper angle of the taper is 0.1-45 degrees, and the length of the functional structure area is 0.5-150 mm.
Preferably, the first guide structure region and the second guide structure region are both conical structures, the taper angles of the first guide structure region and the second guide structure region are respectively and independently 10-85 degrees, and the lengths of the first guide structure region and the second guide structure region are respectively and independently 0.5-10 mm.
The invention provides a progressive expansion balloon, which comprises a balloon body, wherein the balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are sequentially communicated from a proximal end to a distal end, the functional structure area is conical from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than that of the distal end. Compared with the prior art, the whole expansion balloon is of a conical structure, the required expansion can be gradually completed by carrying out one-time or multi-time expansion and back-holding on lesion fibrosis or calcified lesion tissue areas, the damage to blood vessels is reduced, the tearing phenomenon is avoided, and the two ends of the balloon body are guide structure areas, the middle of the balloon body is of a conical functional structure area, so that the balloon is beneficial to gradually pushing, and the balloon can enter a narrow lesion more easily to realize creeping progressive expansion.
Further, the outer surface of the functional structure area is provided with a cutting structure, so that effective cutting force can be provided for the balloon in the expanding process, and the expansion of the balloon to the fibrosis or calcified pathological tissues is facilitated.
Further, an anti-slip structure area is arranged at the proximal end, so that the anti-slip structure area has a good positioning effect in the balloon expanding process, and the watermelon seed effect of the conical balloon in the process of cutting fibrostenosis is prevented.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention provides a progressive expansion balloon, which comprises a balloon body, wherein the balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are sequentially communicated from a proximal end to a distal end, the functional structure area is conical from the proximal end to the distal end, and the diameter of the proximal end of the functional structure area is larger than that of the distal end.
Referring to fig. 1 and 2, fig. 1 and 2 are schematic structural views of a progressive expanding balloon provided by the present invention, wherein a is an overall far-view, B is a side view, 100 is a balloon body, 200 is a cutting structure, 110 is a functional structural region, 120 is an anti-skid structural region, and 130 is a guiding structural region.
The balloon provided by the invention adopts a progressive structure, and the fibrous or calcified lesion tissue region in the blood vessel is gradually expanded through repeated pressurization and pushing of the balloon, so that the damage or tearing of the vessel wall caused by excessive expansion in the operation process is prevented.
Referring to fig. 3 and 4, fig. 3 is a schematic structural view of a blood vessel fibrosis or calcified lesion tissue, wherein the left side view is a schematic longitudinal sectional view, the right side view is a schematic cross-sectional view, 300 is a blood vessel fibrosis or calcified lesion tissue model, 301 is a normal tissue region of the blood vessel model, 302 is a normal tissue region of the blood vessel fibrosis or calcified lesion tissue, fig. 4 is a schematic view of a progressive dilation balloon in the blood vessel fibrosis or calcified lesion tissue, wherein 100 is a balloon body, 201 is an elastic cutting structure, 202 is an elastic anti-slip structure, 301 is a normal tissue region of the blood vessel model, and 302 is a normal tissue region of the blood vessel fibrosis or calcified lesion tissue region.
According to the invention, the balloon body is preferably a nylon balloon body or a nylon plus block polyether amide balloon body, and the balloon body is preferably formed by extruding nylon (PA) or nylon (PA) plus block polyether amide (PEBAX) to prepare a single-cavity tube as a raw material of the balloon body, and then performing hot blow molding on a balloon molding machine containing a convex mold.
The balloon body comprises a first guide structure area, a functional structure area and a second guide structure area which are sequentially communicated from the proximal end to the distal end. The diameter of the functional structure area is preferably 1.0-20 mm, more preferably 1.0-12 mm, still more preferably 1.5-10 mm, still more preferably 2-8 mm, most preferably 2.5-7 mm, the taper angle of the functional structure area is preferably 0.1-45 degrees, more preferably 1-40 degrees, still more preferably 1-35 degrees, still more preferably 1-30 degrees, still more preferably 3-25 degrees, most preferably 3-20 degrees, the taper angle of the functional structure area is specifically 3 degrees, 5 degrees or 20 degrees, the length of the functional structure area is preferably 0.5-150 mm, more preferably 5-150 mm, still more preferably 10-120 mm, most preferably 30-120 mm, and in the embodiment provided by the invention, the length of the functional structure area is specifically 100, 30-120 mm or 120mm.
According to the invention, the outer surface of the functional structural area is preferably provided with cutting structures along the longitudinal direction, in order to realize progressive cutting, when the functional structural area is in a contracted state, the cutting structures are preferably positioned at the outer side of the functional structural area, namely not wrapped by the functional structural area, so that the balloon can realize cutting functions in an expanded state or a gradual expanded state, the cutting structures have good mechanical structures and are favorable for expanding and cutting fibrotic or calcified pathological tissue areas, the number of the cutting structures is preferably 1-10, more preferably 1-8, when the number of the cutting structures is greater than 1, the cutting structures are preferably uniformly distributed on the outer surface of the functional structural area, the cutting structures are preferably bulge cutting structures or elastic cutting structures arranged on the outer surface of the functional structural area, the bulge cutting structures can be continuous or discontinuous structures, when the bulge cutting structures are discontinuous structures, the bulge cutting structures are preferably arranged on the outer surface of the proximal end of the functional structural area, and play roles of fixing anti-skid and cutting at the same time, the bulge cutting structures are preferably triangular or circular, the bulge cutting structures are preferably 1-1 m or 1m, the bulge structures are preferably 0.05-1 mm, the height of the bulge cutting structures is preferably 0.05-1 mm, the most preferably 0.05 mm, the height of the bulge cutting structures is preferably 0.05-1 mm, and the most preferably 0.05 mm, and the width of the bulge cutting structures are preferably 0.0.05 mm, and the most preferably 0.0.05 mm, and the thickness is preferably 0.0.0.0-0.0.0.0.0.0.0.0 mm, and the most preferably 1mm Nickel-iron alloy, tungsten, platinum-tungsten alloy or high-strength high polymer material; the elastic cutting structure is preferably formed by winding monofilaments or multifilaments, The elastic cutting structure is formed by cutting a pipe, the length of the elastic cutting structure is preferably 2-150 mm, more preferably 5-150 mm, still more preferably 10-130 mm and most preferably 30-130 mm, the height of the elastic cutting structure is preferably 0.1-2 mm, more preferably 0.2-1.5 mm, still more preferably 0.2-1 mm, still more preferably 0.3-0.8 mm and most preferably 0.3-0.5 mm, the width of the elastic cutting structure is preferably 0.05-1 mm, more preferably 0.1-1 mm, still more preferably 0.3-1 mm and most preferably 0.3-0.6 mm, and the cross section of the elastic cutting structure is preferably circular, the number of sides of the polygon is preferably 3-10, more preferably 3-8, and still more preferably 3-5. The elastic cutting structure preferably has a gap structure; the gap of the gap structure is preferably 0-0.3 mm, more preferably 0-0.15 mm, still more preferably 0.005-0.1 mm, and most preferably 0.005-0.05 mm; in the embodiment provided by the 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 0.5-150 mm, more preferably 2-145 mm, more preferably 5-140 mm, still more preferably 10-130 mm and most preferably 26-126 mm, in the invention, the elastic cutting structure preferably further comprises a second gap structure, the second gap structure is arranged at the near end of the functional structure area and is larger than the gap of the gap structure, the gap of the second gap structure is preferably 0.002-150 mm, more preferably 0.005-0.8 mm, still more preferably 0.01-0.5 mm, still more preferably 0.01-0.4 mm and most preferably 0.02-0.3 mm, in the embodiment provided by the invention, the gap of the second gap structure is particularly 0.08mm or 0.2mm, the length of the second gap structure is preferably 0.1-50 mm, more preferably 0.5-45 mm, still more preferably 1-40 mm, still more preferably 1-30 mm, the gap of the second gap structure is preferably 1-20 mm, the diameter of the gap structure is preferably 1-20 mm, the gap is preferably 1-2 mm, the gap is more preferably 0.02-0.3 mm, the gap is more preferably 1-10 mm, the gap is preferably 1-2 mm, the gap is preferably the gap is more preferably 1-2 mm, the gap is preferably 1-50 mm is more than the gap is preferably 1-2 mm is preferably 1-5 mm, the gap is more than the gap is preferably 2 and is more than the gap is preferably 2 structure is more is preferably 2 more is preferably the 2 more is preferably 2 the 2 is more is the 2 is more is the more is the is more is the is more is, and meanwhile, the increased clearance can improve the flexibility of the catheter and avoid the damage to the vascular wall.
The progressive expansion balloon provided by the invention preferably further comprises an anti-slip structure area, the first guide structure area is communicated with the functional structure area through the anti-slip structure area, the structural schematic diagram of the progressive expansion balloon provided by the invention is shown in fig. 5, wherein A is an integral far-side view, B is a side view, 110 is the functional structure area, 120 is the anti-slip structure area, 130 is the guide structure area, the anti-slip structure area and the functional structure area are preferably integrally arranged, the anti-slip structure area is preferably cylindrical, namely the inner diameters of the anti-slip structure area along two ends from the proximal end to the distal end are the same or have little difference, the outer diameter of the anti-slip 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, most preferably 2.5-7 mm, the length of the anti-slip structure area is preferably 0.1-50 mm, more preferably 0.5-40 mm, more preferably 1-25 mm, the anti-slip structure area is more preferably 1-25 mm, and the anti-slip structure area is preferably 1-20 mm, and the anti-slip structure area is preferably 1-20 mm. Referring to fig. 6 and 7, fig. 6 and 7 are schematic structural views of a progressive expansion balloon provided by the present invention, wherein 110 is a functional structural area, 111 and 201 are cutting structures, 120 is an anti-slip structural area, 121 is an anti-slip structure, and 130 is a guiding structural area; the anti-skid structure is preferably a raised anti-skid structure or an elastic anti-skid structure arranged on the outer surface of the anti-skid structure area; the height of the protruding anti-skid structure is preferably 0.05-5 mm, more preferably 0.1-3 mm, still more preferably 0.1-2 mm, still more preferably 0.3-1 mm, and most preferably 0.3-0.8 mm; the bump anti-slip structure can be a bump or an annular structure, when the bump anti-slip structure is a bump, the diameter of the bump is preferably 0.1-3 mm, more preferably 0.5-2.5 mm, still more preferably 0.5-2 mm, in the embodiment provided by the invention, the diameter of the bump is specifically 1mm, when the bump anti-slip structure is an annular structure, the number of the bump anti-slip structure is preferably 1-5, more preferably 1-3, still more preferably 1-2, the width of the annular structure is preferably 0.1-3 mm, more preferably 0.1-2 mm, still more preferably 0.1-1.5 mm, most preferably 0.1-1 mm, in the embodiment provided by the 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, the bump anti-slip structure is preferably connected with an elastic cutting structure of a cutting wire, the elastic anti-slip structure preferably comprises a gap structure, the gap structure in the elastic structure is preferably 0.1-3 mm, the gap structure is preferably 0.5-5 mm, still more preferably 0.5mm, most preferably 0.5mm, and most preferably 0.5mm, more preferably 0.5mm, most preferably 0.5mm, more preferably 0.5mm, more than 0.5mm, and most preferably 0mm, preferably 0.5mm, more than 0.5mm, and the diameter, more than 010 mm, more than 0.5mm, and the bump anti-2 mm, and the length, which the bump anti-2, and the anti-2 5, and the anti-2 best 0 best 05, and the anti-2 5, and the anti-2 best 0, and the anti-2, and, are the anti-2, and are the anti-2, and, are the anti-and, are the anti-and, are structures, and are structures, and are structures and are structures and are, The elastic anti-slip structure is preferably an elastic cutting structure formed by winding monofilaments or multiple filaments or cutting a pipe, and the cross section of the elastic anti-slip structure is preferably an inner circle, a semicircle, an ellipse or a polygon.
In the present invention, most preferably, the cutting structure disposed on the outer surface of the functional structure area is an elastic cutting structure, the anti-skidding structure disposed on the outer surface of the anti-skidding structure area is an elastic anti-skidding structure, and the two structures are integrally disposed, that is, the two structures are elastic structures, and the elastic structure area is divided into the elastic cutting structure area and the elastic anti-skidding structure area by the difference between the gap of the gap structure included in the elastic structure and the size of the elastic structure, see fig. 8 and 9, wherein, 201 is an elastic cutting structure, 202 is an elastic anti-skidding structure, a is the gap value of the elastic cutting structure, b is the gap value of the elastic anti-skidding structure, the cutting structure has an excellent force collecting function to be beneficial to cutting and expanding of the blood vessel internal fibrosis or calcified lesion tissues, and the anti-skidding cutting structure has a good anti-skidding function to prevent slipping in the balloon expanding process.
The two ends of the balloon body in the progressive dilation balloon provided by the invention are respectively provided with a first guide structure area and a second guide structure area, the first guide structure area is communicated with a catheter, and the second guide structure area is communicated with an end tube. The guiding structure areas at the two ends can provide guidance for the conveying of the balloon. The first guiding structure area and the second guiding structure area are preferably conical structures, the taper angles of the first guiding structure area and the second guiding structure area are preferably 10-85 degrees, more preferably 20-80 degrees, still more preferably 30-70 degrees and most preferably 35-60 degrees, in the embodiment provided by the invention, the taper angles of the first guiding structure area and the second guiding structure area are preferably 35-40 degrees, 50 degrees or 60 degrees, the lengths of the first guiding structure area and the second guiding structure area are preferably 0.5-10 mm, more preferably 1-6 mm, still more preferably 1-4 mm and most preferably 1-3 mm, the length ratio of the first guiding structure area or the second guiding structure area to the functional structure area is preferably (1-10): (20-200), more preferably (1-8): (20-180), still more preferably (1.5-6): (20-180) and most preferably (1.5): 5-5) and the length of the first guiding structure area and the second guiding structure area is preferably 1-6 mm, and the length ratio of the first guiding structure area and the second guiding structure area is preferably 1-3:1.5:30 or the second guiding structure area is preferably 1:30:1.5:50.
In particular, in the embodiment provided by the invention, the balloon body of the progressive expansion balloon consists of a first guide structure area, a functional structure area and a second guide structure area which are sequentially communicated, wherein a cutting structure is arranged on the outer surface of the functional structure area along the longitudinal direction, the cutting structure is an elastic cutting structure, the elastic cutting structure comprises a gap structure and a second gap structure, and the second gap structure plays a role in skid resistance at the same time under the structure.
In another embodiment provided by the invention, the balloon body of the progressive dilation balloon consists of a first guide structure area, an anti-skid structure area, a functional structure area and a second guide structure area which are sequentially communicated from the proximal end to the distal end, the outer surface of the anti-skid structure area is of a smooth structure, a cutting structure is longitudinally arranged on the outer surface of the functional structure area, the cutting structure is an elastic cutting structure, the elastic cutting structure comprises a gap structure and a second gap structure, and the second gap structure plays a role in skid resistance at the same time under the structure.
In another embodiment provided by the invention, the balloon body of the progressive dilation balloon consists of a first guide structure area, an anti-skid structure area, a functional structure area and a second guide structure area which are sequentially communicated from the proximal end to the distal end, the outer surface of the anti-skid structure area is of a smooth structure, a cutting structure is longitudinally arranged on the outer surface of the functional structure area, the cutting structure is an elastic cutting structure, the elastic cutting structure comprises a gap structure and a second gap structure, and the second gap structure plays a role in skid resistance at the same time under the structure.
In another embodiment provided by the invention, the balloon body of the progressive dilation balloon consists of a first guide structure area, an anti-skid structure area, a functional structure area and a second guide structure area which are sequentially communicated from the proximal end to the distal end, wherein an anti-skid structure is arranged on the outer surface of the anti-skid structure area, a cutting structure is arranged on the outer surface of the functional structure area along the longitudinal direction, and under the structure, the cutting structure can be a convex cutting structure or an elastic cutting structure as the anti-skid structure area is provided with the anti-skid structure, and the elastic cutting structure can only comprise a gap structure and can also comprise the gap structure and the second gap structure.
The whole of the expansion balloon is of a conical structure, the lesion fibrosis or calcified lesion tissue region can be progressively cut through one or more expansions and recoil of the balloon, the required expansion is gradually completed, the damage to blood vessels is reduced, the tearing phenomenon is avoided, the two ends of the balloon body are provided with guide structure regions, the middle of the balloon body is provided with a conical functional structure region, the gradual propulsion of the balloon is facilitated, and the balloon can enter a narrow lesion more easily to realize creeping progressive expansion.
Further, the outer surface of the functional structure area is provided with a cutting structure, so that effective cutting force can be provided for the balloon in the expanding process, and the expansion of the balloon to the fibrosis or calcified pathological tissues is facilitated.
Further, an anti-slip structure area is arranged at the proximal end, so that the anti-slip structure area has a good positioning effect in the balloon expanding process, and the watermelon seed effect of the conical balloon in the process of cutting fibrostenosis is prevented.
Most preferably, the progressive dilation balloon provided by the invention comprises an anti-skid area with good anti-skid fixing effect and a functional structure area capable of providing good dilation cutting effect. The balloon is cut for multiple times and progressively to effectively expand the fibrosis or calcified lesion tissue region, so that the damage to blood vessels is reduced, and the tearing phenomenon is avoided.
The method comprises the steps of firstly conveying a progressive expansion balloon to a preset position, then starting pressurizing the balloon, enabling an anti-slip area to be in contact with blood vessel fibrosis or calcified lesion tissues preferentially in the pressurizing process and fixed, preventing the balloon from slipping in the expanding process, gradually cutting and expanding the contacted fibrosis or calcified lesion areas by a conical balloon expansion area along with the rising of the balloon pressure, discharging the balloon pressure to negative pressure after the balloon expansion area is completed, further pushing the balloon forward to the preset position, repeating the pressurizing process to cut and expand the fibrosis or calcified lesion areas, and repeating the cutting and expanding of the required fibrosis or calcified lesion areas repeatedly according to actual requirements. Referring to fig. 10 to 15, fig. 10 to 13 are schematic diagrams of a cutting process of a progressive dilation balloon provided by the invention, wherein 100 is a balloon body, 201 is an elastic cutting structure, 202 is an elastic anti-slip structure, 301 is a normal tissue region of a blood vessel model, 302 is a blood vessel fibrosis or calcified lesion tissue region, fig. 14 is a schematic diagram of a section of the progressive dilation balloon after back-embracing, 100 is a balloon body, 200 is a cutting structure, and fig. 15 is a schematic diagram of a ceramic ring vascular calcified lesion tissue model.
To further illustrate the present invention, a progressive dilation balloon provided by the present invention is described in detail below in connection with examples.
The reagents used in the examples below are all commercially available.
Example 1
As shown in FIG. 2, the embodiment provides a progressive cutting and expanding balloon, which consists of a balloon body 100 and a cutting function mechanism 200, wherein the balloon body 100 is composed of a guide structure 130 with a taper of 40 degrees 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 degrees and a length of 100mm, 4 elastic structures are uniformly adhered to the outer side, the elastic structures are formed by winding nickel-titanium filaments with an outer diameter of 0.05mm, the length is 105mm, the height is 0.5mm and the width is 0.4mm, the gap at the cutting structure of the elastic structures is 0.02mm and the length is 98mm, and the gap at the anti-slip structure of the elastic structures is 0.2mm and the length is 7mm, as shown in FIG. 8.
The progressive cutting and expanding balloon is pushed to a target position required by the inner side of a lesion length of 150mm, then the pressure is gradually increased to 18 atmospheres on the balloon, the cutting wire anti-skid functional structure 202 is firstly contacted with the calcified lesion tissue 302 and gradually strengthens the fixing force along with the increase of the balloon pressure, meanwhile, the calcified lesion tissue 302 is gradually cut and expanded along the balloon taper direction along the cutting structure 201 of the functional structure area 110, the balloon pressure is released to negative pressure after the completion, the balloon is pushed to a preset position, the cutting and expanding are carried out on the calcified lesion tissue area by repeating the pressurizing process in fig. 11, the cutting and expanding of all the calcified lesion tissue area are repeatedly carried out for 8 times, and finally, the intravascular calcified lesion tissue is completely opened, as shown in fig. 13.
The balloon cutting process is stable without sliding phenomenon in the expanding process, and simultaneously, the required expanding pressure is reduced by more than 30 percent compared with that of a common balloon due to the adoption of the balloon with the cutting wire in a conical shape and the progressive expanding mode, and the phenomenon of damage and rupture of the wall of the blood vessel is avoided in the middle process.
Example 2
As shown in FIG. 2, the present embodiment provides a progressive cutting and expanding balloon, which is composed of a balloon body 100 and a cutting function mechanism 200, wherein the balloon body 100 is composed of a guiding structure 130 with a taper of 60 degrees, a length of 1.5mm, a taper of 50 degrees, a length of 1.6mm and a taper of 3 degrees, and a functional structure area 110 with a length of 30mm, and the outer diameter of the proximal end of the functional structure area is 10mm, as shown in FIG. 1.
The outside evenly adheres 4 elastic structures to be shown in figure 2, the elastic structure is formed by cutting a nickel titanium triangular tube through laser, the length is 26mm, the height is 0.3mm, the width is 0.3mm, the cutting structure clearance of the elastic structure is 0.02mm, the length is 20mm, the second clearance structure clearance of the elastic structure is 0.08mm, the length is 6mm, the cross section of the balloon body cutting structure 111 after folding is shown in figure 14, and the cutting structure 200 is positioned outside the balloon body 100.
The progressive cutting and expanding balloon is pushed into the fibrosis tissue with the lesion length of 24mm, then the pressure is gradually increased to 25 atmospheres to the balloon, the anti-skid functional structure 202 of the elastic structure is firstly contacted with the fibrosis tissue 302 and gradually strengthened along with the increase of the balloon pressure, meanwhile, the fibrosis tissue 302 is gradually cut and expanded along the cutting wire 201 of the balloon cutting functional area 110 along the balloon taper direction, as shown in fig. 10, the fibrosis or calcified lesion tissue area in the blood vessel is completely opened after the cutting and expanding is completed, as shown in fig. 13, due to the short lesion length, the longer cutting functional area and the smaller taper.
The balloon cutting process is stable without sliding phenomenon in the process, and the wall injury and rupture phenomenon of the blood vessel are not seen in the middle process.
Example 3
As shown in fig. 2, the present embodiment provides a progressive cutting and expanding balloon, which is composed of a balloon body 100 and a cutting functional mechanism 200, and as shown in fig. 6, the balloon body 100 is composed of a guiding structural region 130 with a taper of 50 ° and a length of 3mm at the distal end and a taper of 35 ° and a length of 5mm at the proximal end, an anti-slip structural region 120 with an outer diameter of 4mm and a length of 2mm, and a functional structural region 110 with a taper of 5 ° and a length of 50 mm. The anti-skid structure 120 is characterized in that 2 anti-skid structures with the width of 0.4mm, the height of 0.3mm and the width of 0.6mm and the height of 0.4mm are uniformly distributed on the outer side.
The progressive cutting and expanding balloon is pushed into the fibrosis tissue with the lesion length of 65mm, then the pressure is gradually increased to 20 atmospheres to the balloon, the anti-slip structure 121 is firstly contacted with the fibrosis tissue 302 and gradually strengthened along with the increase of the balloon pressure, meanwhile, the fibrosis tissue 302 is gradually cut and expanded along the balloon taper direction along the cutting structure 111 of the functional structure area 110 as shown in fig. 10, the balloon pressure is released to negative pressure after the completion, the balloon is pushed forward to a preset position as shown in fig. 11, the pressurizing process is repeated to cut and expand the fibrosis tissue area as shown in fig. 12, the cutting and expanding of all the fibrosis tissue areas are repeatedly progressive for 4 times, and finally the fibrosis tissue in the blood vessel is completely opened as shown in fig. 13.
In the process, the balloon cutting process is stable and has no sliding phenomenon in the expanding process, and meanwhile, the balloon with the cutting wire in a conical shape and the progressive expanding mode are adopted, so that the phenomenon of damage and rupture of the wall of the blood vessel is avoided in the middle process.
Example 4
As shown in fig. 2, the present embodiment provides a progressive cutting and expanding balloon, which is composed of a balloon body 100 and a cutting function mechanism 200. The balloon body 100 is composed of a guiding structure area 130 with the taper of 60 degrees and the length of 3mm, an anti-skid structure area 120 with the outer diameter of 7mm and the length of 12mm, and a functional structure area 110 with the taper of 3 degrees and the length of 120 mm. The outside of the anti-skid structure area 120 is uniformly distributed with 50 anti-skid salient points with the diameter of 1mm and the height of 0.8mm, 3 cutting wires are uniformly adhered to the outside of the balloon, as shown in fig. 7, the cutting wires are formed by cutting nickel titanium triangular pipes by laser, the length is 136mm, the height is 0.4mm and the width is 0.45mm, the cutting wires only have a cutting structure, the gap is 0.03mm and the length is 116mm, the section of the cutting structure 111 of the balloon body after the balloon body is folded is shown in fig. 14, and the cutting structure 200 is positioned on the outside of the balloon body 100.
The progressive expansion balloon provided in the embodiment 4 of the present invention (the taper structure angle and the proportion of each region are the same, but the lengths of each region are different according to the difference of the maximum outer diameter and the total length of the balloon) and the boston science MustangTM are placed into the corresponding vascular calcified lesion tissue model, specifically the ceramic ring figure 15, and the cutting expansion test is performed, and the cutting expansion effect of the progressive expansion balloon provided in the present invention is significantly better than that of the control group MustangTM, specifically the following table 1.
Table 1 comparison of cutting expansion test data