Integral exchange type peripheral balloon dilatation catheter

Abstract

The embodiment of the utility model provides an integral exchange type peripheral balloon dilatation catheter, and relates to the field of medical instruments. The overall exchange type peripheral balloon dilatation catheter comprises a protective sleeve, a balloon, a balloon woven layer, a fixing ring, a developing ring, a double-cavity tube, a catheter base sleeve and a catheter base. The overall exchange type balloon dilatation catheter is compact in structural design, and due to the special design of the balloon braid layer, the pressure resistance of the balloon is improved, and transverse breakage of the balloon can be avoided; and due to the design of the protective sleeve, the pushing performance of the balloon catheter can be improved, and the fish mouth effect is avoided.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to an integral exchangeable peripheral balloon dilatation catheter. Background Art

[0002] Peripheral vascular stenosis and disease are mainly caused by peripheral arteriosclerosis; peripheral vascular stenosis is often accompanied by the formation of calcified areas or dense plaques. For lesions with mild calcification, ordinary balloons can be used for dilation, but in severely calcified lesions, ordinary balloons cannot effectively open the stenosis, which will bring the risk of secondary surgery to patients. High-pressure balloons are a better way to solve this problem.

[0003] In addition, stenosis of arteriovenous fistula (AVF) is often caused by damage to the intima of the vascular pathway, which leads to hyperplasia, causing an increase in smooth muscle cells and extracellular matrices such as elastin, proteoglycans, and collagen in the middle layer of the fistula. Therefore, ordinary balloons are basically ineffective against thickened vascular walls and fibrotic thrombi, and greater pressure is required to fully open the stenotic lesions. During the AVF expansion process, damage to the vascular wall should be avoided, so the balloon product needs to be resistant to high pressure, and its deformation rate should be as small as possible while the high-pressure expansion squeezes the lesion area.

[0004] Due to the characteristics of the hemodialysis access, the stenosis lesions are mainly hyperplastic, which puts higher requirements on the instruments used in the current mainstream minimally invasive intracavitary balloon dilatation treatment. For some severe stenosis, even using a balloon dilatation catheter with a dilation pressure of 30ATM still cannot achieve full dilation.

[0005] Therefore, a balloon catheter that is resistant to ultra-high pressure and has low compliance has always been an important technical hurdle that the vascular intervention industry wants to overcome. Utility Model Content

[0006] The utility model provides an integral exchange type peripheral balloon dilatation catheter, which can greatly improve the pressure resistance, pushing performance and retractability of the balloon catheter.

[0007] The embodiments of the present invention can be implemented as follows:

[0008] The utility model provides an integral exchangeable peripheral balloon dilatation catheter, comprising:

[0009] A protective sleeve (1), which is a conical structure and is arranged at the distal end of the integral exchangeable peripheral balloon dilatation catheter;

[0010] A balloon (2), the balloon comprising a double-layer structure of a segmented polyetheramide inner layer and a nylon outer layer;

[0011] The balloon braided layer (3) is formed by alternately braiding two or more braided threads; the braided layer is coated on the outside of the balloon;

[0012] A fixing ring (4), which is used to fix the balloon;

[0013] Two developing rings (5) are arranged on the inner tube (62) at intervals;

[0014] A double-lumen tube (6), the double-lumen tube consisting of an inner tube (62) and an outer tube (61), the outer tube being sleeved on the outer side of the inner tube, and the inner tube being used for guiding the guide wire;

[0015] A catheter seat sleeve (7), wherein the catheter seat sleeve is fixed at the junction of the catheter and the catheter seat;

[0016] The catheter seat (8) is used to fix the inner tube and the outer tube.

[0017] In an optional embodiment, the catheter seat is arranged at the proximal end of the double-lumen tube, the balloon is arranged at the distal end of the double-lumen tube, and the balloon can be divided into a balloon body, a balloon shoulder and a balloon foot.

[0018] In an optional embodiment, the balloon braided layer is fixed to the balloon surface by UV curing glue. Of course, it can also be fixed by other fixing methods known in the art, such as thermal welding.

[0019] In an optional embodiment, the protective sleeve is attached to the distal balloon pin and the inner tube by heat welding. Of course, other fixing methods known in the art, such as gluing, etc., may also be used for fixing.

[0020] In an optional embodiment, the developing ring is arranged on the inner tube corresponding to the position of the balloon body.

[0021] In an optional embodiment, the balloon braided layer is woven in a two-dimensional three-way braided form, wherein the width of the axial yarn is 1-2 times the width of the braided yarn. The widths of the axial yarn and the braided yarn are controlled by the number of parallel strands, for example, the braided yarn is twisted from 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20 strands, and the axial yarn is twisted from 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 40 strands.

[0022] In an optional embodiment, the number of PPIs of the balloon braided layer is 35-45, and optionally 35, 36, 37, 38, 39, 40, 41, 41, 42, 43, 44, 45. PPI refers to the number of crosses of the braided yarns per inch of length in the braided material.

[0023] The beneficial effects of the balloon dilatation catheter of the utility model embodiment include, for example:

[0024] The utility model provides an integral exchangeable balloon dilatation catheter, which comprises a protective sleeve, a balloon, a balloon braided layer, a fixing ring, a developing ring, a double-lumen tube, a catheter seat sleeve and a catheter seat. The integral exchangeable balloon dilatation catheter of the present application has a compact structure design, and the special design of the balloon braided layer improves the pressure resistance of the balloon and can avoid the lateral fracture of the balloon; the design of the protective sleeve can improve the pushing performance of the balloon catheter and avoid the occurrence of the fish mouth effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the utility model, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the utility model and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 A schematic diagram of an integral exchangeable balloon dilatation catheter provided in an embodiment of the utility model;

[0027] Figure 2 A schematic diagram of a balloon braided layer provided in an embodiment of the utility model;

[0028] Figure 3 It is a schematic diagram of an enlarged body of a balloon braided layer provided in an embodiment of the utility model;

[0029] Figure 4 A schematic diagram of a cross section of a double-lumen tube provided in an embodiment of the present utility model;

[0030] Figure 5 A cross-sectional view of a double-lumen tube provided in an embodiment of the utility model;

[0031] Figure 6 A schematic diagram of the fish mouth effect provided in an embodiment of the utility model;

[0032] Figure 7 A schematic diagram of the balloon structure provided in an embodiment of the utility model;

[0033] Figure 8 This is a diagram of balloon non-compliance test results provided in an embodiment of the present utility model.

[0034] Icons: 1-protective cover; 2-balloon; 211-balloon body; 212-balloon shoulder; 213-balloon tube foot; 3-balloon braided layer; 311-axial yarn; 312-braided yarn; 4-fixing ring; 5-developing ring; 6-double-lumen tube; 61-outer tube; 62-inner tube; 7-catheter seat sleeve; 8-catheter seat. DETAILED DESCRIPTION

[0035] In order to make the purpose, technical scheme and advantages of the embodiments of the utility model clearer, the technical scheme in the embodiments of the utility model will be clearly and completely described below in conjunction with the drawings in the embodiments of the utility model. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Generally, the components of the embodiments of the utility model described and shown in the drawings here can be arranged and designed in various different configurations.

[0036] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the present invention to be protected, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] According to the clinical usage scenario, the end of the balloon dilatation catheter close to the doctor is defined as the proximal end of the balloon dilatation catheter, and the end away from the doctor is defined as the distal end.

[0038] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0039] In the description of the present utility model, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the accompanying drawings, or is the orientation or position relationship in which the utility model product is usually placed when used. It is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present utility model.

[0040] In addition, the terms “first”, “second”, etc., if used, are merely used to distinguish between the descriptions and should not be understood as indicating or implying relative importance.

[0041] In the description of the present utility model, the integral exchange peripheral dilatation balloon catheter may be referred to as a peripheral balloon dilatation catheter, a balloon dilatation catheter or a balloon catheter, which all have the same meaning as the integral exchange peripheral dilatation balloon catheter.

[0042] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0043] As mentioned in the background technology, a balloon dilatation catheter is a soft catheter with an inflatable balloon at the tip, which is used to dilate narrow hollow organs in the human body, such as blood vessels, digestive tract, urinary tract, etc., under image guidance. The balloon dilatation catheter enters the target lesion site without expansion. After reaching the lesion site, the balloon is pressurized and expanded. After the treatment is successful, the balloon dilatation catheter can be smoothly withdrawn from the body.

[0044] In view of this, please refer to Figure 1-Figure 8 The balloon dilatation catheter provided in the embodiment of the utility model can solve this problem, which will be described in detail below.

[0045] The present invention provides an integral exchangeable peripheral balloon dilatation catheter in an embodiment. Figure 1 As shown in the example, the balloon dilatation catheter includes a protective sleeve mounted at the most distal end from the distal end to the proximal end, one end of the protective sleeve is attached to the distal balloon tube pin, and the other end covers the inner tube. The protective sleeve has a conical structure. The balloon dilatation catheter without the protective sleeve has an exposed inner tube, which is cylindrical. This shape cannot fit well with the guide wire when passing through a tortuous section ( Figure 6 ), which is prone to fish-mouth effect, making it difficult for the balloon catheter to pass through the tortuous section and scratching the blood vessels.

[0046] The balloon is welded on the double-lumen tube, the proximal pin of the balloon is welded on the outer tube of the double-lumen tube, and the distal end of the balloon is welded on the inner tube of the double-lumen tube. The welding method can be thermal welding or laser welding. The balloon can be filled, expanded and contracted by the filling cavity formed by the outer tube and the inner tube of the double-lumen tube; there is a fixing ring at the proximal balloon pin, and the material of the fixing ring can be the same as or different from that of the double-lumen tube. A part of the fixing ring covers the braided wire of the proximal balloon pin, and the other part is on the outer tube of the double-lumen tube. The fixing ring has a round appearance without edges.

[0047] like Figure 7 The balloon 3 shown can be divided into a balloon body 311, a balloon shoulder 312 and a balloon tube foot 313, and a developing ring 5 is sleeved on the outer periphery of the inner tube corresponding to the balloon body.

[0048] It should be noted that the balloon adopts a double-layer structure design, the inner layer is block polyetheramide, the outer layer is nylon, the diameter of the balloon can be selected from 3 to 20 mm, preferably 4 to 12 mm, and the length of the balloon can be selected from 10 to 100 mm, preferably 20 to 100 mm.

[0049] In addition, if Figure 2 and Figure 3As shown, the balloon may include a balloon braided layer arranged on the balloon, and the balloon braided layer may cover the outer surface of the balloon. It is understandable that the balloon braided layer may completely cover the outer surface of the balloon or may partially cover the outer surface of the balloon. The braiding method of the balloon braided layer adopts a two-dimensional three-way braiding form, wherein the width of the axial yarn is 1-2 times the width of the braided yarn. The use of a wider axial yarn can not only increase the bursting pressure of the balloon, but also can cause the balloon to form a longitudinal rupture without a transverse rupture even if the balloon unfortunately explodes. This is particularly important. A balloon that ruptures transversely in a blood vessel not only increases its outer contour, but also forms sharp corners, which scratch the blood vessel during the withdrawal of the balloon, bringing surgical risks. Preferably, the balloon braided layer is fixed to the balloon surface by coating UV curing glue. It is foreseeable that other fixing methods commonly used in the art can also be used to fix the balloon braided layer to the surface of the balloon.

[0050] Based on the above embodiments, preferably, the weaving density of the balloon braided layer is 35-45 PPI. If it is too dense, the balloon will be too hard after being wrapped, which is not conducive to the filling and contraction of the balloon. If it is too sparse, it will not play a supporting role and the bursting pressure of the balloon will be insufficient.

[0051] It should be noted that the developing ring 5 can be set to platinum, iridium, tungsten or alloy material. The developing ring 5 is fixed to the outside of the inner tube 3 corresponding to the balloon body 311, and the fixing method of the developing ring 5 and the inner tube 3 is preferably bonding or ring forging. The developing ring 5 can effectively mark the position and effective length of the balloon 3, enhance the development effect of the balloon 3 under ultrasound, and improve the use effect of the balloon dilatation catheter.

[0052] In addition, the balloon 3 provided in the above embodiment has a double-layer membrane structure, wherein the inner layer is Pebax and the outer layer is nylon. The inner layer and the outer layer are co-extruded to form a composite tube, and dry nitrogen is blown under high pressure to form a catheter balloon.

[0053] Furthermore, the balloon dilatation catheter of the present application also includes a catheter seat sleeve 7. The outer periphery of the proximal end of the double-lumen tube 6 is sleeved with the catheter seat sleeve 7. The catheter seat sleeve 7 can remove the stress generated by the balloon dilatation catheter during use and prevent the catheter from wrinkling during transportation, so as to ensure the smooth movement and use effect of the device.

[0054] The double lumen tube of the present application is as Figure 4 and Figure 5 As shown, 61 is an outer tube, forming a filling cavity, which is connected to the balloon, and the balloon can be inflated / deflated by infusing / suctioning air or reagents, and the reagents are preferably contrast agents, saline, etc.; 62 is an inner tube, forming a guidewire cavity for accommodating the guidewire.

[0055] In order to further illustrate the use effect of the integral exchangeable peripheral balloon dilatation catheter provided by the utility model, an experimental demonstration is performed below. Example 1 is a balloon dilatation catheter prepared by the design scheme of the present application, Comparative Example 1 is an Athletis balloon dilatation catheter (Boston Scientific), and Comparative Example 2 is a Conquest40 balloon dilatation catheter (Bard).

[0056] The burst pressure test method refers to the YY 0285.4 standard, and the results are shown in the following table:

[0057] Table 1

[0058] Grouping Burst Pressure Example 1 62ATM Scale 1 56ATM Scale 2 55ATM

[0059] From Table 1, it can be seen that the balloon dilatation catheter designed in this application can improve the pressure resistance of the balloon, which can not only better expand the stenosis of the blood vessel, but also the stronger pressure resistance also greatly improves the safety and application range of the balloon, which has great practical significance for handling complex vascular occlusion procedures.

[0060] During the burst pressure test, the outer diameter of the balloon was measured and recorded at different pressure values. Figure 8 As shown in the figure, it can be seen that the outer diameter of the balloon dilatation catheter of the embodiment designed in the present application hardly expands after reaching the rated pressure of 20ATM, while the outer diameter of the balloon of comparative example 1 (rated pressure 20ATM) and comparative example 2 (rated pressure 12ATM) continues to increase with the pressure after reaching the rated pressure, indicating that the balloon dilatation catheter prepared in the present application has better non-compliance than comparative example 1 and comparative example 2, and is more conducive to the dilation of stenotic lesions.

[0061] Each embodiment in this specification is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referenced to each other. Any combination of all embodiments provided by the utility model is within the protection scope of this utility model and will not be described in detail here.

[0062] The above is only a specific implementation of the utility model, but the protection scope of the utility model is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the utility model should be included in the protection scope of the utility model. Therefore, the protection scope of the utility model should be based on the protection scope of the claims.

Claims

1. An integral exchangeable peripheral balloon dilatation catheter, characterized in that: include: A protective sleeve, which is a conical structure and is arranged at the distal end of the integral exchange peripheral balloon dilatation catheter; A balloon, the balloon comprising a double-layer structure of a segmented polyetheramide inner layer and a nylon outer layer; The balloon braided layer is formed by alternately braiding two or more braided threads; the braided layer is coated on the outside of the balloon; A fixing ring, the fixing ring is used to fix the balloon; Two developing rings are arranged on the inner tube at intervals; A double-lumen tube, the double-lumen tube is composed of an inner tube and an outer tube, the outer tube is sleeved on the outer side of the inner tube, and the inner tube is used to guide the guide wire; A catheter seat sleeve, wherein the catheter seat sleeve is fixed at the junction of the catheter and the catheter seat; The catheter seat is used to fix the inner tube and the outer tube.

2. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The catheter seat is arranged at the proximal end of the double-lumen tube, and the balloon is arranged at the distal end of the double-lumen tube.

3. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The balloon comprises a balloon body, a balloon shoulder and a balloon pin.

4. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The balloon braided layer is fixed to the balloon surface by UV curing glue.

5. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The protective sleeve is mounted on the distal balloon pin and the inner tube by thermal welding.

6. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The developing ring is arranged on the inner tube corresponding to the position of the balloon body.

7. The integral exchange peripheral balloon dilatation catheter according to claim 1, characterized in that: The balloon braided layer is woven in a two-dimensional three-way braided form, wherein the width of the axial yarn is 1-2 times the width of the braided yarn.

8. The integral exchange peripheral balloon dilatation catheter according to claim 7, characterized in that: The number of PPIs of the balloon braided layer is 35-45.

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