WO2024131743A1 - Medical balloon and preparation method therefor, and balloon catheter - Google Patents

Medical balloon and preparation method therefor, and balloon catheter Download PDF

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Publication number
WO2024131743A1
WO2024131743A1 PCT/CN2023/139689 CN2023139689W WO2024131743A1 WO 2024131743 A1 WO2024131743 A1 WO 2024131743A1 CN 2023139689 W CN2023139689 W CN 2023139689W WO 2024131743 A1 WO2024131743 A1 WO 2024131743A1
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WO
WIPO (PCT)
Prior art keywords
balloon
layer
balloon body
braided
pins
Prior art date
Application number
PCT/CN2023/139689
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French (fr)
Chinese (zh)
Inventor
陈丽君
陈景民
王成
Original Assignee
上海博脉安医疗科技有限公司
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Publication date
Application filed by 上海博脉安医疗科技有限公司 filed Critical 上海博脉安医疗科技有限公司
Publication of WO2024131743A1 publication Critical patent/WO2024131743A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a medical balloon and a preparation method thereof, and a balloon catheter.
  • Peripheral vascular stenosis and disease are mainly caused by peripheral arteriovenous sclerosis; most of the cases of peripheral vascular stenosis and occlusion are highly calcified and moderately fibrotic blood vessels. Ordinary balloons cannot expand the lesions. Even if they are expanded under higher pressure, due to the dog-bone effect and the compliance of the balloon itself, the expanded diameter will be much larger than the nominal diameter, causing more serious damage to the blood vessels. Therefore, the angioplasty of the lower limb arteries, especially the iliac artery and the superficial femoral artery, requires a high-pressure resistant non-compliant balloon dilatation catheter.
  • arteriovenous fistula stenosis is often caused by the damage to the intima of the vascular pathway, which leads to hyperplasia, causing an increase in smooth muscle cells and elastin, proteoglycans, collagen and other extracellular matrices 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.
  • vascular wall damage should be avoided more, 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. 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.
  • the patent application with the patent number WO2019172931A1 discloses a method for increasing the bursting pressure of a balloon through a fiber reinforcement device.
  • the authorized patent with the patent number CN110139689B discloses a medical balloon with a reinforcement member, which is made by adding or strengthening materials to obtain a high-pressure resistant balloon. Although this method can increase the bursting pressure of the balloon, it reduces the flexibility and permeability of the balloon, and greatly increases the outer diameter of the balloon after folding. Pretreatment is required for highly stenotic lesions.
  • the object of the present invention is to provide a medical balloon and a preparation method thereof, and a balloon catheter.
  • the medical balloon has low compliance, high flexibility and high permeability.
  • An embodiment of the present invention provides a medical balloon, comprising: a balloon body, wherein an axially penetrating cavity is provided inside the balloon body; a braided layer is sleeved on the outside of the balloon body; the braided layer is woven by braiding wire; and an adhesive layer covers the outside of the balloon body and/or the braided layer.
  • the medical balloon includes two pins and two cones, the two axial ends of the balloon body are connected, and the two cones respectively connect the two pins and the two axial ends of the balloon body;
  • the braided layer is further arranged on the outside of the two pins and the two cones, and/or the adhesive layer is further arranged on the outside of the braided layer located outside the two pins and the two cones.
  • the diameter of the medical balloon is 2 mm to 12 mm, and/or the thickness of the balloon is 0.0006 inches to 0.002 inches.
  • the density of the braided layer on the outside of the medical balloon and the density of the braided layer on the outside of the cone portion are both greater than the density of the braided layer on the outside of the balloon body.
  • the material of the braided wire is a combination of one or more of polyethylene terephthalate, polyethylene, polyurethane, stainless steel and nickel titanium alloy.
  • the braided layer is formed by braiding the braided wires in the form of weft or warp and weft.
  • the adhesive layer is made of a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate.
  • the present invention also provides a method for preparing the balloon catheter as described above, comprising the following steps:
  • a bonding layer is made on the outside of the braided layer by a coating process, and the balloon body and the braided layer are fixed as a whole by the bonding layer.
  • the S100 further includes:
  • Two pins and two cones are made at the two axial ends of the balloon body, wherein the two The two cones are connected to the two pins and the two axial ends of the balloon body, respectively, so that the balloon body, the two pins and the two cones are integrally formed;
  • the two pins and the two cones are inflated with air.
  • the S200 further includes:
  • the braided layer is manufactured around the two pins and the two cones, so that the braided layer on the outside of the balloon body and the braided layer on the outside of the two pins and the two cones are integrally formed;
  • the S300 further includes: manufacturing the bonding layer on the outer sides of the two pins and the two cones by a coating process, and/or manufacturing the bonding layer on the outside of the braided layer on the outer sides of the two pins and the two cones by a coating process.
  • the step S300 further includes:
  • a binder Dissolving a binder in a solvent to form a binder solution for use in the coating process, wherein the binder is a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate;
  • the concentration of the binder in the binding solution is 1wt% to 20wt%.
  • the solvent includes tetrahydrofuran
  • the solution also includes glue
  • the ratio of the binder to the tetrahydrofuran is 1:30 to 1:3.
  • the solvent further comprises dimethylacetamide, and the volume ratio of the tetrahydrofuran to the dimethylacetamide is greater than 0 and less than or equal to 1.
  • step S400 is further included:
  • the reinforcing sleeve is melted by laser welding, hot air welding or heat sealing welding, and the braided layer and the adhesive layer covering the outside of the tube pin are fixed to the tube pin through the reinforcing sleeve.
  • An embodiment of the present invention further provides a balloon catheter, comprising the medical balloon as described in any one of the above items;
  • An outer tube is sleeved on the outside of the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon body.
  • the medical balloon and its preparation method, and the balloon catheter provided by the present invention have the following advantages:
  • the medical balloon provided by the present invention is provided with a woven layer on the outside of the balloon body, which limits the expansion degree of the balloon body during inflation, reduces the compliance of the balloon body, and improves the pressure resistance of the balloon body; and to achieve the same expansion pressure, the single-layer balloon or double-layer balloon in the prior art requires a certain wall thickness to achieve it, while the woven layer is provided on the outside of the balloon body of the present invention, so that the balloon body has a smaller wall thickness while still achieving the required expansion pressure, thereby reducing the wall thickness of the balloon body and improving the compliance of the balloon; the medical balloon provided by the present invention is also provided with an adhesive layer on the outside of the balloon body and/or the woven layer, and the balloon and the woven layer are adhered together by the adhesive layer to form an integrated ultra-high pressure balloon, which can avoid the problem of repeated inflation and depressurization of the balloon during use causing the woven layer to slip and dislocate, thereby causing a large area of the balloon to be exposed and explode, making the protective function
  • FIG1 is a schematic diagram of a balloon catheter according to an embodiment of the present invention.
  • FIG2 is a cross-sectional view of a single-layer balloon body according to an embodiment of the present invention.
  • FIG3 is a cross-sectional view of a double-layer balloon body according to an embodiment of the present invention.
  • FIG4 is a front view of a balloon body according to an embodiment of the present invention.
  • FIG5 is a cross-sectional view of a medical balloon according to an embodiment of the present invention.
  • FIG6 is a schematic diagram of a warp-woven medical balloon according to an embodiment of the present invention.
  • FIG7 is a schematic diagram of a plain weave of warp and weft threads according to an embodiment of the present invention.
  • FIG8 is an enlarged view of the circled area at the balloon body in FIG7 ;
  • FIG9 is a schematic diagram of warp and weft oblique weaving according to an embodiment of the present invention.
  • FIG10 is an enlarged view of the circled area in FIG9 ;
  • FIG11 is a schematic diagram of warp and weft skew weaving according to another embodiment of the present invention.
  • FIG12 is a schematic diagram of a weft plain weave according to an embodiment of the present invention.
  • FIG13 is a schematic diagram of a weft twill weave according to an embodiment of the present invention.
  • FIG14 is an enlarged view of the circled area in FIG13 ;
  • FIG15 is a schematic diagram of a weft twill weave according to another embodiment of the present invention.
  • FIG16 is a comparison chart of the compliance test of the high pressure resistant balloon provided by the present invention and the ordinary balloon (prior art);
  • FIG17 is a flow chart of a method for preparing a medical balloon according to an embodiment of the present invention.
  • FIG18 is an enlarged view of the circled area at the pin of FIG7 ;
  • FIG19 is a schematic diagram of a free braided wire after welding according to an embodiment of the present invention.
  • FIG. 20 is a schematic diagram of free braided wire after welding according to another embodiment of the present invention.
  • the present invention provides a medical balloon, as shown in FIGS. 1 to 13 , the medical balloon comprises:
  • the balloon body 1 has an axially penetrating cavity inside.
  • the braided layer 2 is sleeved on the outer side of the balloon body 1; the braided layer 2 is braided by braiding wires 21;
  • the adhesive layer 3 covers the outer side of the balloon body 1 and/or the braided layer 2 .
  • the bonding layer 3 is made of a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate.
  • the thickness of the bonding layer 3 can be set according to actual needs, which is higher or lower than the thickness of the braided layer 2, and is not limited here.
  • the coating of the bonding layer 3 can be lower than the braiding thickness or higher than the braiding thickness according to the process requirements.
  • the balloon body and the braided layer are tightly adhered together by the adhesive layer to form an integrated ultra-high pressure balloon, which avoids fatigue and blasting due to limit slippage and dislocation, resulting in large-area exposure of the balloon and failure of the protective function of the braided layer.
  • the present invention sets a braided layer on the outside of the balloon body, which limits the expansion degree of the balloon body during inflation, reduces the compliance of the medical balloon, and improves the pressure resistance of the medical balloon; under a certain expansion pressure, a single-layer medical balloon or a double-layer medical balloon requires a certain wall thickness to reach the required expansion pressure, and the outer wall of the balloon body is provided with a braided layer, so that the medical balloon has a smaller wall thickness and can also reach the required expansion pressure, thereby improving the compliance of the medical balloon; the medical balloon provided by the present invention has a simple process and low cost.
  • the material of the balloon body 1 is a combination of one or more of nylon, polyetheramide (PEBAX) and polyethylene terephthalate (PET).
  • the balloon body 1 can be a single-layer balloon, or a multi-layer balloon formed by co-extrusion blow molding of multiple materials in a certain proportion. As shown in FIG2 , a cross section of a single-layer balloon body is shown; as shown in FIG3 , a cross section of a double-layer balloon body is shown.
  • the wall thickness of the high-pressure balloon in the prior art is about 0.003 inches to 0.006 inches.
  • the present invention reduces the thickness of the balloon to about half of the wall thickness of the similar double-layer balloon in the prior art by cooperating the balloon with the braided layer.
  • the smaller balloon wall thickness can improve the overall flexibility of the balloon catheter, taking into account the smaller outer diameter of the balloon contour and the passing performance of the balloon.
  • the diameter of the balloon 1 is 2mm to 12mm, and/or the thickness of the balloon body 1 is 0.0006 inches to 0.002 inches.
  • the medical balloon 1 also includes two pins 4 and two cones 5, the two pins 11 are respectively connected to the axial ends of the balloon body 1, and the two cones 12 respectively connect the two pins 11 to the axial ends of the balloon body 1;
  • the braided layer 2 is also arranged on the outside of the two pins 11 and the two cones 12;
  • the adhesive layer 3 is also arranged on the outside of the braided layer 2 outside the two pins 11 and the two cones 12.
  • the braided wire 21 is used to form a braided layer from the inflated balloon body.
  • the outer surface of the body 1 is woven, starting from the pin 11 at one end, then to a cone 12 and the balloon body 1, and then to the cone 12 and the pin 11 at the other end, so that the weaving of the braided layer 2 is completed.
  • the braided layer 2 is a tubular mesh structure, covering the entire balloon body 1 along the axial direction.
  • the wall thickness of the medical balloon 1 gradually changes from thick to thin from the pin 11, the cone 12 to the balloon body 1, and the diameters of the pin 11, the cone 12 and the balloon body 13 are from small to large. Therefore, as shown in Figure 7, when the braided layer 2 is woven from the pin 11, the cone 12 to the outside of the balloon body 1, the braided wire 21 is woven from dense to sparse. That is, the density of the braided layer 2 on the outside of the pin 11 and the density of the braided layer 2 on the outside of the cone 12 are both greater than the density of the braided layer 2 on the outside of the balloon body 1.
  • the braided wire 21 includes a polymer braided wire and/or a metal wire, such as a combination of one or more of polyester, polyolefin, polyamide, stainless steel and nickel-titanium alloy.
  • the material of the braided wire 21 can be polyethylene terephthalate, polyethylene, or polyurethane.
  • the braided wire 21 is an ultra-high density polyethylene (UHDPE) fiber in the polyolefin class, which has excellent mechanical properties, elastic modulus and extremely fine filament fineness (single filament fineness is about 0.01 to 0.02 mm).
  • UHDPE ultra-high density polyethylene
  • the wall thickness of the overall balloon body 1 is similar to or even smaller than the wall thickness of the balloon body in the prior art, and a smaller balloon folding outer diameter and flexibility can be maintained.
  • braided fibers of different specifications such as 10D to 100D can be selected.
  • the braided layer 2 is configured to be braided by braiding wire 21 with weft or warp and weft.
  • the warp and weft weaving method is to divide the braided wire 21 into warp 211 and weft 212, the warp 211 is a braided wire parallel to the axial direction of the balloon body 1, and the weft 212 is a braided wire that forms an angle with the axial direction of the balloon body 1.
  • the warp 211 can be set to 4 to 64 braided wires according to the size of the balloon body 1.
  • the warp 211 can be woven on the balloon body 1 first.
  • the balloon body 1 is woven with warp 211, and the warp 211 can be evenly distributed on the surface of the balloon body 1, or unevenly distributed, and the user can set it according to the needs.
  • the warp is intertwined with the weft in different weaving methods, such as plain weaving of warp and weft, twill weaving of warp and weft, etc.
  • the braided layer 2 is the warp and weft intertwined by plain weaving.
  • the warp and weft are woven in a plain weave
  • the warp 211 and the weft 212 are interlaced and woven, and the angle between the warp 211 and the weft 212 is 90°.
  • the warp and weft when the warp and weft are woven in a twill weave, the warp 211 is always in the middle, and the weft 212 is woven in an up-and-down staggered manner, and the angle between the warp 211 and the weft 212 is 10° to 90°; as shown in Figure 11, the warp and weft can also be woven in a twill weave.
  • the wires 212 are interlaced and twisted up and down, and the twisting angle is 180° to 720°.
  • the twisting angle is the angle at which the weft wires are wound around the circumference of the balloon body.
  • Weft weaving refers to a weaving pattern without warp weaving, only weft, which may include plain weaving of weft, diagonal weaving of weft, etc.
  • the weft 212 is woven at 90° to the axial direction of the balloon body 1.
  • the weft is woven in diagonal weaving, the weft 212 is woven in an up-and-down staggered manner, and the angle between the wefts 212 is between 10° and 180°; or as shown in FIG15, the weft 212 is woven in a twisted manner, and the twisting angle is between 180° and 720°.
  • the medical balloon provided in the present invention and the existing single-layer balloon were subjected to a compliance comparison test.
  • the material of the single-layer balloon is nylon, and the two balloons have the same size.
  • the horizontal axis is pressure, the unit is atm (atmospheric pressure), and the vertical axis is diameter, the unit is mm (millimeter).
  • the test results show that the bursting pressure of the existing single-layer balloon is 26atm, and the diameter changes greatly with the increase of pressure; the pressure resistance of the medical balloon provided in the present invention can reach 50atm, and the diameter changes less with the increase of pressure than the existing single-layer balloon. Therefore, the medical balloon provided by the present invention has high pressure resistance, which can reach 50atm, and low compliance.
  • an embodiment of the present invention further provides a method for preparing the above-mentioned medical balloon, comprising the following steps:
  • Step S100 providing a balloon body 1, and inflating the balloon body 1; by inflating the balloon, the main balloon maintains a certain shape, which is convenient for weaving the braided layer 2, and the inflation pressure of the balloon body can be 0.5atm-rated pressure;
  • Step S200 providing a braided wire 21 to form a braided layer 2 around the balloon body 1; the braided wire 21 may be twisted or pre-coated with glue before braiding to prevent the single wire from breaking due to friction or other reasons during the production process;
  • Step S300 a bonding layer 3 is made on the outside of the braided layer 2 by a coating process (such as spraying, dipping, etc.), and the balloon body 1 and the braided layer 2 are fixed as a whole by the bonding layer 3.
  • a coating process such as spraying, dipping, etc.
  • the braided layer limits the expansion degree of the balloon body during inflation, reduces the compliance of the balloon, and improves the pressure resistance of the balloon; the arrangement of the braided layer enables the balloon to have a smaller wall thickness, thereby improving the flexibility of the balloon; the balloon catheter provided by the present invention has a simple process and low cost.
  • step S100 also includes the following steps:
  • Two pins 11 and two cones 12 are made at the axial ends of the balloon body 2, wherein the two cones 12 respectively connect the two pins 11 and the axial ends of the balloon body 1, so that the balloon body 1, the two pins 11 and the two cones 12 are integrally formed;
  • the two pins 11 and the two cones 12 are inflated with air.
  • step S200 also includes:
  • a braided layer 2 is manufactured around the two pins 11 and the two cones 12, so that the braided layer 2 on the outside of the balloon body 1 is integrally formed with the braided layer 2 on the outside of the two pins 11 and the two cones 12;
  • step S300 also includes:
  • the adhesive layer 3 is formed on the outer sides of the two pins 11 and the two cones 12 by a coating process, and/or the adhesive layer 3 is formed on the outside of the braided layer 2 on the outer sides of the two pins 11 and the two cones 12 by a coating process.
  • Step S300 also includes:
  • the binder is dissolved in a solvent to form a binder solution for use in a coating process, wherein the binder is a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate; and the concentration of the binder in the binder solution is 1wt% to 20wt%.
  • the solvent includes tetrahydrofuran, and the volume ratio of the binder to the tetrahydrofuran is 1:30 to 1:3.
  • the solvent in order to adjust the film-forming rate of the bonding layer, further includes dimethylacetamide, and the volume ratio of dimethylacetamide to tetrahydrofuran is greater than 0 and less than or equal to 1.
  • step S300 After the ultra-high pressure balloon part is completed, as shown in FIG18 , the braided wires 21 placed on the pins 11 are in a free state, and the braided wires 21 of the two pins 11 in a free state need to be fixed. Further, after step S300, the following step S400 is also included:
  • a reinforcing sleeve 6 is provided, and the reinforcing sleeve 6 is sleeved on the outside of the tube pin 11; the reinforcing sleeve 6 is melted by laser welding, hot air welding or heat sealing welding, and the braided layer 2 covering the outside of the tube pin 11 is melted through the reinforcing sleeve 6, and the braided wire 21 is fixed to the tube pin 11 through penetration and flow.
  • the free braided wire 21 near one end of the inner tube 4 is welded to the reinforcing sleeve 6 to form a welding area 7.
  • the free braided wire 21 at one end of the outer tube 5 also forms a welding area 7 as shown in Figure 20 (not shown in the figure).
  • an embodiment of the present invention further provides a balloon catheter, comprising:
  • An inner tube 4 the inner tube 4 passes through the cavity of the balloon body 1, and the distal end of the inner tube 4 is connected to the distal end of the balloon body 1;
  • the outer tube 5 is sleeved on the outside of the inner tube 4 , and the distal end of the outer tube 5 is connected to the proximal end of the balloon body 1 .
  • the medical balloon further includes a pin and a cone
  • the inner tube is connected to the distal end of the balloon body through the pin and the cone; the outer tube is also connected to the proximal end of the balloon body through the pin and the cone.
  • the balloon catheter provided in the embodiment of the present invention includes the medical balloon as described above, and thus can achieve all the technical effects of the above-mentioned medical balloon, which will not be described in detail here.
  • the medical balloon and its preparation method, balloon catheter and its preparation method provided by the present invention have the following advantages:
  • the braided layer woven on the outside of the balloon body limits the expansion of the balloon body, so that the bursting pressure of the medical balloon can reach 50atm, reducing the compliance of the medical balloon; the setting of the braided layer enables the balloon body to have a smaller composite layer wall thickness, good overall flexibility, and a smaller outer diameter of the folded contour, thereby improving the passability of the medical balloon; compared with the prior art, the preparation process of the medical balloon in the present invention is simple and the cost is low.

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Abstract

A medical balloon and a preparation method therefor, and a balloon catheter. The medical balloon comprises a balloon body (1), wherein an axially unobstructed cavity is provided in the balloon body (1); a woven layer (2) sleeving on the outer side of the balloon body (1), wherein the woven layer (2) is woven from a weaving thread (21); and a bonding layer (3) covering the outer side of the balloon body (1) and/or the woven layer (2). By providing the woven layer (2) outside the balloon body (1), the degree of expansion of the balloon body (1) during inflation is limited, the compliance of the balloon body (1) is reduced, and the pressure resistance of the balloon is improved; the arrangement of the woven layer (2) reduces the wall thickness of the balloon and improves the flexibility of the balloon; by providing the bonding layer on the outer side of the balloon body and/or the woven layer, the balloon and the woven layer are adhered together by means of the bonding layer, so that an integrated ultrahigh-pressure balloon is formed, which can avoid the failure of the protective function of the woven layer when repeated inflation and deflation of the balloon during use causes the woven layer to glide and dislocate and thereby lead to large-area exposure of the balloon and bursting.

Description

一种医用球囊及其制备方法、球囊导管Medical balloon and preparation method thereof, and balloon catheter 技术领域Technical Field
本发明涉及医疗器械技术领域，具体涉及一种医用球囊及其制备方法、球囊导管。The present invention relates to the technical field of medical devices, and in particular to a medical balloon and a preparation method thereof, and a balloon catheter.
背景技术Background technique
外周血管的狭窄和疾病主要是因为外周动脉硬化；外周血管的狭窄和闭塞病例中多数是带有高度钙化，以及中度的纤维化血管，普通球囊无法扩开病变部位，即使在较高压力下扩开，由于狗骨头效应以及球囊本身的顺应性，扩开直径会远远大于名义直径，对血管造成较为严重的损伤，所以下肢动脉，特别是髂动脉和股浅动脉的血管成型需要耐高压的非顺应性球囊扩张导管。另外，动静脉瘘(AVF，arteriovenous fistula)狭窄往往是因为血管通路内膜受损导致增生，引起内瘘中层平滑肌细胞和弹性蛋白及蛋白多糖、胶原等细胞外基质的增多，故普通球囊针对增厚的血管壁和纤维化血栓基本无效，需要更大的压力才能充分打开狭窄病变。在AVF扩张过程中，应更加避免血管壁损伤，故需要球囊产品耐高压，在高压扩张挤压病变区域的同时其形变率应尽可能小。因此，一款耐超高压、低顺应性的球囊导管一直是血管介入行业想要突破的重要技术难关。Peripheral vascular stenosis and disease are mainly caused by peripheral arteriovenous sclerosis; most of the cases of peripheral vascular stenosis and occlusion are highly calcified and moderately fibrotic blood vessels. Ordinary balloons cannot expand the lesions. Even if they are expanded under higher pressure, due to the dog-bone effect and the compliance of the balloon itself, the expanded diameter will be much larger than the nominal diameter, causing more serious damage to the blood vessels. Therefore, the angioplasty of the lower limb arteries, especially the iliac artery and the superficial femoral artery, requires a high-pressure resistant non-compliant balloon dilatation catheter. In addition, arteriovenous fistula (AVF) stenosis is often caused by the damage to the intima of the vascular pathway, which leads to hyperplasia, causing an increase in smooth muscle cells and elastin, proteoglycans, collagen and other extracellular matrices 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, vascular wall damage should be avoided more, 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. 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.
专利号为WO2019172931A1的申请专利公开了一种通过纤维增强装置用于提高球囊***压。专利号为CN110139689B的授权专利公开了一种带加强构件的医用球囊，通过增加或强化材料制作球囊，从而获得耐高压球囊。这种方式虽然可以提高球囊***压力，但是降低了球囊的柔顺性、通过性，同时大大增加了球囊折叠后的轮廓外径，对于高度狭窄的病变需要先进行预处理。The patent application with the patent number WO2019172931A1 discloses a method for increasing the bursting pressure of a balloon through a fiber reinforcement device. The authorized patent with the patent number CN110139689B discloses a medical balloon with a reinforcement member, which is made by adding or strengthening materials to obtain a high-pressure resistant balloon. Although this method can increase the bursting pressure of the balloon, it reduces the flexibility and permeability of the balloon, and greatly increases the outer diameter of the balloon after folding. Pretreatment is required for highly stenotic lesions.
发明内容 Summary of the invention
针对现有技术中的问题，本发明的目的在于提供一种医用球囊及其制备方法、球囊导管，所述医用球囊具有低顺应性、高柔顺性和高通过性。In view of the problems in the prior art, the object of the present invention is to provide a medical balloon and a preparation method thereof, and a balloon catheter. The medical balloon has low compliance, high flexibility and high permeability.
本发明实施例提供一种医用球囊，包括：球囊主体，所述球囊主体的内部设有一轴向贯通的腔体；编织层，套设于所述球囊主体的外侧；所述编织层通过编织丝编织而成；粘结层，覆于所述球囊主体和/或所述编织层的外侧。An embodiment of the present invention provides a medical balloon, comprising: a balloon body, wherein an axially penetrating cavity is provided inside the balloon body; a braided layer is sleeved on the outside of the balloon body; the braided layer is woven by braiding wire; and an adhesive layer covers the outside of the balloon body and/or the braided layer.
在一些实施例中，所述医用球囊包括两个管脚和两个锥部，所述球囊主体的轴向两端相连通，两个所述锥部分别连接两个所述管脚与所述球囊主体的轴向两端；In some embodiments, the medical balloon includes two pins and two cones, the two axial ends of the balloon body are connected, and the two cones respectively connect the two pins and the two axial ends of the balloon body;
所述编织层还设置于两个所述管脚和两个所述锥部的外侧，和/或所述粘结层还设置于位于两个所述管脚和两个所述锥部外侧的所述编织层的外侧。The braided layer is further arranged on the outside of the two pins and the two cones, and/or the adhesive layer is further arranged on the outside of the braided layer located outside the two pins and the two cones.
在一些实施例中，所述医用球囊的直径为2mm～12mm，和/或，所述球囊的厚度为0.0006英寸～0.002英寸。In some embodiments, the diameter of the medical balloon is 2 mm to 12 mm, and/or the thickness of the balloon is 0.0006 inches to 0.002 inches.
在一些实施例中，所述医用球囊的外侧的所述编织层的密度和所述锥部的外侧的所述编织层的密度均大于所述球囊主体的外侧的所述编织层的密度。In some embodiments, the density of the braided layer on the outside of the medical balloon and the density of the braided layer on the outside of the cone portion are both greater than the density of the braided layer on the outside of the balloon body.
在一些实施例中，所述编织丝的材料为聚对苯二甲酸乙二酯、聚乙烯、聚氨基甲酸酯、不锈钢和镍钛合金中的一种或多种的组合。In some embodiments, the material of the braided wire is a combination of one or more of polyethylene terephthalate, polyethylene, polyurethane, stainless steel and nickel titanium alloy.
在一些实施例中，所述编织层设置由所述编织丝以纬线编织或经纬线编织而成。In some embodiments, the braided layer is formed by braiding the braided wires in the form of weft or warp and weft.
在一些实施例中，所述粘结层是由热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合制成。本发明实施例还提供了一种根据如上所述的球囊导管的制备方法，包括如下步骤：In some embodiments, the adhesive layer is made of a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate. The present invention also provides a method for preparing the balloon catheter as described above, comprising the following steps:
S100：提供一所述球囊，向所述球囊主体内充气；S100: providing a balloon, and inflating the balloon body;
S200：提供所述编织丝，围绕所述球囊主体制作所述编织层；S200: providing the braided wire, and making the braided layer around the balloon body;
S300：通过涂敷工艺在所述编织层的外部制作粘结层，通过所述粘结层将所述球囊主体与所述编织层固定为一体。S300: A bonding layer is made on the outside of the braided layer by a coating process, and the balloon body and the braided layer are fixed as a whole by the bonding layer.
在一些实施例中，所述S100还包括：In some embodiments, the S100 further includes:
在所述球囊主体的轴向两端制作两个管脚和两个锥部，其中，所述两 个锥部分别连接所述两个管脚与所述球囊主体的轴向两端，以使所述球囊主体、所述两个管脚和所述两个锥部一体成型；以及Two pins and two cones are made at the two axial ends of the balloon body, wherein the two The two cones are connected to the two pins and the two axial ends of the balloon body, respectively, so that the balloon body, the two pins and the two cones are integrally formed; and
向所述两个管脚和所述两个锥部内充气。The two pins and the two cones are inflated with air.
在一些实施例中，所述S200还包括：In some embodiments, the S200 further includes:
围绕所述连个管脚和所述两个锥部制作所述编织层，以使所述球囊主体的外侧的所述编织层与所述两个管脚和所述两个锥部的外侧的所述编织层一体成型；The braided layer is manufactured around the two pins and the two cones, so that the braided layer on the outside of the balloon body and the braided layer on the outside of the two pins and the two cones are integrally formed;
所述S300还包括：通过涂敷工艺在两个管脚和所述两个锥部的外侧制作所述粘结层，和/或，通过涂敷工艺在所述两个管脚和所述两个锥部的外侧的所述编织层的外部制作所述粘结层。The S300 further includes: manufacturing the bonding layer on the outer sides of the two pins and the two cones by a coating process, and/or manufacturing the bonding layer on the outside of the braided layer on the outer sides of the two pins and the two cones by a coating process.
在一些实施例中，所述步骤S300还包括：In some embodiments, the step S300 further includes:
将粘结剂溶于溶剂中，制作形成粘结溶液，以用于所述涂敷工艺，其中，所述粘结剂为热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合；Dissolving a binder in a solvent to form a binder solution for use in the coating process, wherein the binder is a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate;
其中，所述粘结剂在所述粘结溶液中的浓度为1wt％～20wt％。Wherein, the concentration of the binder in the binding solution is 1wt% to 20wt%.
在一些实施例中，所述溶剂包括四氢呋喃，所述溶液中还包括胶水，所述粘结剂与所述四氢呋喃的比例为1:30～1:3。In some embodiments, the solvent includes tetrahydrofuran, the solution also includes glue, and the ratio of the binder to the tetrahydrofuran is 1:30 to 1:3.
在一些实施例中，所述溶剂还包括二甲基乙酰胺，与所述四氢呋喃与所述二甲基乙酰胺的体积比为大于0且小于等于1。在一些实施例中，所述S300之后，还包括如下步骤S400：In some embodiments, the solvent further comprises dimethylacetamide, and the volume ratio of the tetrahydrofuran to the dimethylacetamide is greater than 0 and less than or equal to 1. In some embodiments, after S300, the following step S400 is further included:
提供一加强套管，将所述加强套管套设于所述管脚的外部；Providing a reinforcing sleeve, and sleeve the reinforcing sleeve on the outside of the pin;
通过激光焊接、热风焊接或热合焊接将所述加强套管熔融，通过所述加强套管将覆于管脚的外部的所述编织层及所述粘结层固定于所述管脚上。The reinforcing sleeve is melted by laser welding, hot air welding or heat sealing welding, and the braided layer and the adhesive layer covering the outside of the tube pin are fixed to the tube pin through the reinforcing sleeve.
本发明实施例还提供了一种球囊导管，包括如上任一项所述的医用球囊；An embodiment of the present invention further provides a balloon catheter, comprising the medical balloon as described in any one of the above items;
内管，所述内管贯穿所述球囊主体的所述腔体，所述内管的远端与所述球囊主体的远端相连；以及an inner tube, the inner tube passing through the cavity of the balloon body, the distal end of the inner tube being connected to the distal end of the balloon body; and
外管，所述外管套设在所述内管的外部，所述外管的远端与所述球囊主体的近端相连。 An outer tube is sleeved on the outside of the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon body.
本发明所提供的医用球囊及其制备方法、球囊导管具有如下优点：The medical balloon and its preparation method, and the balloon catheter provided by the present invention have the following advantages:
本发明提供的医用球囊在球囊主体的外部设置编织层，限制了球囊主体充气过程中的膨胀程度，降低了球囊主体的顺应性，提高了球囊主体耐压性；并且要实现相同的扩张压力，现有技术的单层球囊或双层球囊需要一定的壁厚才能实现，而本发明球囊主体的外侧设置编织层，可以使球囊主体具有较小的壁厚的同时也可达到所需扩张压力，从而减小了球囊主体的壁厚，提高了球囊的柔顺性；本发明提供的医用球囊在球囊主体和/或编织层外侧还设置有粘结层，通过粘结层将球囊与编织层粘附在一起，成为一体的超高压球囊，可以避免使用时球囊反复充压泄压导致编织层滑移错位，进而导致球囊大面积裸露而发生***，使所述编织层的保护功能失效的问题。The medical balloon provided by the present invention is provided with a woven layer on the outside of the balloon body, which limits the expansion degree of the balloon body during inflation, reduces the compliance of the balloon body, and improves the pressure resistance of the balloon body; and to achieve the same expansion pressure, the single-layer balloon or double-layer balloon in the prior art requires a certain wall thickness to achieve it, while the woven layer is provided on the outside of the balloon body of the present invention, so that the balloon body has a smaller wall thickness while still achieving the required expansion pressure, thereby reducing the wall thickness of the balloon body and improving the compliance of the balloon; the medical balloon provided by the present invention is also provided with an adhesive layer on the outside of the balloon body and/or the woven layer, and the balloon and the woven layer are adhered together by the adhesive layer to form an integrated ultra-high pressure balloon, which can avoid the problem of repeated inflation and depressurization of the balloon during use causing the woven layer to slip and dislocate, thereby causing a large area of the balloon to be exposed and explode, making the protective function of the woven layer ineffective.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
通过阅读参照以下附图对非限制性实施例所作的详细描述，本发明的其它特征、目的和优点将会变得更明显。Other features, objectives and advantages of the present invention will become more apparent from a reading of the detailed description of non-limiting embodiments made with reference to the following accompanying drawings.
图1是本发明一实施例的球囊导管的示意图；FIG1 is a schematic diagram of a balloon catheter according to an embodiment of the present invention;
图2是本发明一实施例的单层球囊主体的截面图；FIG2 is a cross-sectional view of a single-layer balloon body according to an embodiment of the present invention;
图3是本发明一实施例的双层球囊主体的截面图；FIG3 is a cross-sectional view of a double-layer balloon body according to an embodiment of the present invention;
图4是本发明一实施例的球囊主体的主视图；FIG4 is a front view of a balloon body according to an embodiment of the present invention;
图5是本发明一实施例的医用球囊的截面图；FIG5 is a cross-sectional view of a medical balloon according to an embodiment of the present invention;
图6是本发明一实施例的经线编织的医用球囊的示意图；FIG6 is a schematic diagram of a warp-woven medical balloon according to an embodiment of the present invention;
图7是本发明一实施例的经纬线平织的示意图；FIG7 is a schematic diagram of a plain weave of warp and weft threads according to an embodiment of the present invention;
图8是图7中的球囊主体处的圆圈区域的放大图；FIG8 is an enlarged view of the circled area at the balloon body in FIG7 ;
图9是本发明一实施例的经纬线斜织的示意图；FIG9 is a schematic diagram of warp and weft oblique weaving according to an embodiment of the present invention;
图10是图9圆圈区域的放大图；FIG10 is an enlarged view of the circled area in FIG9 ;
图11是本发明另一实施例的经纬线斜织的示意图；FIG11 is a schematic diagram of warp and weft skew weaving according to another embodiment of the present invention;
图12是本发明一实施例的纬线平织的示意图；FIG12 is a schematic diagram of a weft plain weave according to an embodiment of the present invention;
图13是本发明一实施例的纬线斜织的示意图；FIG13 is a schematic diagram of a weft twill weave according to an embodiment of the present invention;
图14是图13圆圈区域的放大图；FIG14 is an enlarged view of the circled area in FIG13 ;
图15是本发明另一实施例的纬线斜织的示意图； FIG15 is a schematic diagram of a weft twill weave according to another embodiment of the present invention;
图16是本发明提供的耐高压球囊与普通球囊(现有技术)的顺应性测试对比图；FIG16 is a comparison chart of the compliance test of the high pressure resistant balloon provided by the present invention and the ordinary balloon (prior art);
图17是本发明一实施例的医用球囊的制备方法的流程图；FIG17 is a flow chart of a method for preparing a medical balloon according to an embodiment of the present invention;
图18是图7的管脚处的圆圈区域的放大图；FIG18 is an enlarged view of the circled area at the pin of FIG7 ;
图19是本发明一实施例的游离态的编织丝焊接后的示意图；FIG19 is a schematic diagram of a free braided wire after welding according to an embodiment of the present invention;
图20是本发明另一实施例的游离态的编织丝焊接后的示意图。FIG. 20 is a schematic diagram of free braided wire after welding according to another embodiment of the present invention.
附图标记：Reference numerals:
1    球囊主体1    Balloon body
11   管脚11   Pin
12   锥部12   Cone
2    编织层2    Braid
21   编织丝21   Braided silk
211  经线211  Meridian
212  纬线212  Latitude
3    粘结层3    Adhesive layer
4    内管4    Inner tube
5    外管5    External pipe
6    加强套管6    Reinforce the casing
7    焊接区域7    Welding area
具体实施方式Detailed ways
现在将参考附图更全面地描述示例实施方式。然而，示例实施方式能够以多种形式实施，且不应被理解为限于在此阐述的实施方式；相反，提供这些实施方式使得本发明将全面和完整，并将示例实施方式的构思全面地传达给本领域的技术人员。在图中相同的附图标记表示相同或类似的结构，因而将省略对它们的重复描述。说明书中的“或”、“或者”均可能表示“和”或者“或”。Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be implemented in a variety of forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that the present invention will be comprehensive and complete and fully convey the concepts of the example embodiments to those skilled in the art. In the figures, the same reference numerals represent the same or similar structures, and thus their repeated description will be omitted. "or" and "or" in the specification may both mean "and" or "or".
为解决现有技术问题，本发明提供一种医用球囊，如图1至图13所示，医用球囊包括：In order to solve the problems of the prior art, the present invention provides a medical balloon, as shown in FIGS. 1 to 13 , the medical balloon comprises:
球囊主体1，球囊主体1的内部设有一轴向贯通的腔体； The balloon body 1 has an axially penetrating cavity inside.
编织层2，套设于球囊主体1的外侧；编织层2通过编织丝21编织而成；The braided layer 2 is sleeved on the outer side of the balloon body 1; the braided layer 2 is braided by braiding wires 21;
粘结层3，覆于球囊主体1和/或编织层2的外侧。The adhesive layer 3 covers the outer side of the balloon body 1 and/or the braided layer 2 .
具体地，在一些实施例中，粘结层3是由热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合制成。粘结层3的厚度可以根据实际需求设置，高于或低于编织层2的厚度，此处不做限制。粘结层3的涂敷根据工艺需要，可低于编织厚度，也可高于编织厚度。Specifically, in some embodiments, the bonding layer 3 is made of a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate. The thickness of the bonding layer 3 can be set according to actual needs, which is higher or lower than the thickness of the braided layer 2, and is not limited here. The coating of the bonding layer 3 can be lower than the braiding thickness or higher than the braiding thickness according to the process requirements.
通过粘结层将球囊主体与编织层紧紧粘附在一起，成为一个一体的超高压球囊，避免疲劳及***过程中因限位滑移错位，导致球囊大面积裸露，使编织层的保护功能失效。本发明通过在球囊主体的外部设置编织层，编织层限制球囊主体充气过程中的膨胀程度，降低了医用球囊的顺应性，提高了医用球囊的耐压性；在一定的扩张压力下，单层医用球囊或双层医用球囊需要一定的壁厚才能达到所需扩张压力，而球囊主体的外壁设置编织层，可以使医用球囊具有较小的壁厚也可达到所需扩张压力，从而提高了医用球囊的柔顺性；本发明提供的医用球囊工艺简单，成本低。The balloon body and the braided layer are tightly adhered together by the adhesive layer to form an integrated ultra-high pressure balloon, which avoids fatigue and blasting due to limit slippage and dislocation, resulting in large-area exposure of the balloon and failure of the protective function of the braided layer. The present invention sets a braided layer on the outside of the balloon body, which limits the expansion degree of the balloon body during inflation, reduces the compliance of the medical balloon, and improves the pressure resistance of the medical balloon; under a certain expansion pressure, a single-layer medical balloon or a double-layer medical balloon requires a certain wall thickness to reach the required expansion pressure, and the outer wall of the balloon body is provided with a braided layer, so that the medical balloon has a smaller wall thickness and can also reach the required expansion pressure, thereby improving the compliance of the medical balloon; the medical balloon provided by the present invention has a simple process and low cost.
具体地，球囊主体1的材料为尼龙、聚醚酰胺(PEBAX)和聚对苯二甲酸乙二酯(PET)中的一种或多种的组合。球囊主体1可以为单层球囊，或多种材料按照一定比例共挤吹塑形成的多层球囊。如图2所示，示出了一单层的球囊主体的截面；如图3所示，示出了一双层球囊主体的截面。Specifically, the material of the balloon body 1 is a combination of one or more of nylon, polyetheramide (PEBAX) and polyethylene terephthalate (PET). The balloon body 1 can be a single-layer balloon, or a multi-layer balloon formed by co-extrusion blow molding of multiple materials in a certain proportion. As shown in FIG2 , a cross section of a single-layer balloon body is shown; as shown in FIG3 , a cross section of a double-layer balloon body is shown.
现有技术的高压球囊壁厚约为0.003英寸-0.006英寸，本发明通过球囊与编织层配合，球囊的厚度可减小为现有技术中的同类双层球囊壁厚的一半左右。较小的球囊壁厚可提高球囊导管整体的柔顺性，兼顾较小的球囊轮廓外径和球囊的通过性能。优选地，球囊1的直径为2mm～12mm，和/或，球囊主体1的厚度为0.0006英寸～0.002英寸。如图1至图13所示，医用球囊1还包括两个管脚4和两个锥部5，两个管脚11分别与球囊主体1的轴向两端连通，两个锥部12分别连接两个管脚11与球囊主体1的轴向两端；编织层2还设置于两个管脚11和两个锥部12的外侧；粘结层3还设置于两个管脚11和两个锥部12外侧的编织层2的外侧。本实施例中，在球囊主体1的外部编织编织层2时，用编织丝21从充气的球囊主 体1的外表面进行编织，从一端的管脚11开始编织，后至一个锥部12及球囊主体1，然后再至另一端的锥部12及管脚11，至此完成编织层2的编织，编织层2为管状网状结构，沿轴向覆盖整个球囊主体1。医用球囊1的壁厚从管脚11、锥部12到球囊主体1的厚度是逐渐由厚变薄，管脚11、锥部12和球囊体13的直径从小到大，因此如图7所示，从管脚11、锥部12到球囊主体1的外部进行编织编织层2时，编织丝21为由密到疏的原则进行编织。即管脚11的外侧的编织层2的密度及锥部12的外侧的编织层2的密度均大于球囊主体1的外侧的编织层2的密度。The wall thickness of the high-pressure balloon in the prior art is about 0.003 inches to 0.006 inches. The present invention reduces the thickness of the balloon to about half of the wall thickness of the similar double-layer balloon in the prior art by cooperating the balloon with the braided layer. The smaller balloon wall thickness can improve the overall flexibility of the balloon catheter, taking into account the smaller outer diameter of the balloon contour and the passing performance of the balloon. Preferably, the diameter of the balloon 1 is 2mm to 12mm, and/or the thickness of the balloon body 1 is 0.0006 inches to 0.002 inches. As shown in Figures 1 to 13, the medical balloon 1 also includes two pins 4 and two cones 5, the two pins 11 are respectively connected to the axial ends of the balloon body 1, and the two cones 12 respectively connect the two pins 11 to the axial ends of the balloon body 1; the braided layer 2 is also arranged on the outside of the two pins 11 and the two cones 12; the adhesive layer 3 is also arranged on the outside of the braided layer 2 outside the two pins 11 and the two cones 12. In this embodiment, when the braided layer 2 is braided on the outside of the balloon body 1, the braided wire 21 is used to form a braided layer from the inflated balloon body. The outer surface of the body 1 is woven, starting from the pin 11 at one end, then to a cone 12 and the balloon body 1, and then to the cone 12 and the pin 11 at the other end, so that the weaving of the braided layer 2 is completed. The braided layer 2 is a tubular mesh structure, covering the entire balloon body 1 along the axial direction. The wall thickness of the medical balloon 1 gradually changes from thick to thin from the pin 11, the cone 12 to the balloon body 1, and the diameters of the pin 11, the cone 12 and the balloon body 13 are from small to large. Therefore, as shown in Figure 7, when the braided layer 2 is woven from the pin 11, the cone 12 to the outside of the balloon body 1, the braided wire 21 is woven from dense to sparse. That is, the density of the braided layer 2 on the outside of the pin 11 and the density of the braided layer 2 on the outside of the cone 12 are both greater than the density of the braided layer 2 on the outside of the balloon body 1.
进一步地，编织丝21包括高分子聚合物编织丝和/或金属丝，如聚酯类、聚烯烃类、聚酰胺类、不锈钢类和镍钛合金类中的一种或多种的组合。当编织丝21为高分子聚合物编织丝时，编织丝21的材料可以为聚对苯二甲酸乙二酯、聚乙烯、聚氨基甲酸。优选地，编织丝21为聚烯烃类中的超高密度聚乙烯(UHDPE)纤维，具有优异的机械性能、弹性模量以及极细的长丝细度(单丝细度约为0.01～0.02mm)，当其编织至球囊主体1后，整体的球囊主体1的壁厚与现有技术中的球囊主体的壁厚相近甚至更小些，能够维持较小的球囊折叠外径及柔顺性。根据球囊主体的尺寸不同，可选择10D～100D等不同规格的编织纤维。Further, the braided wire 21 includes a polymer braided wire and/or a metal wire, such as a combination of one or more of polyester, polyolefin, polyamide, stainless steel and nickel-titanium alloy. When the braided wire 21 is a polymer braided wire, the material of the braided wire 21 can be polyethylene terephthalate, polyethylene, or polyurethane. Preferably, the braided wire 21 is an ultra-high density polyethylene (UHDPE) fiber in the polyolefin class, which has excellent mechanical properties, elastic modulus and extremely fine filament fineness (single filament fineness is about 0.01 to 0.02 mm). When it is woven into the balloon body 1, the wall thickness of the overall balloon body 1 is similar to or even smaller than the wall thickness of the balloon body in the prior art, and a smaller balloon folding outer diameter and flexibility can be maintained. Depending on the size of the balloon body, braided fibers of different specifications such as 10D to 100D can be selected.
如图6至图15所示，编织层2设置为由编织丝21以纬线编织或经纬线编织而成。具体地，经纬线编织方式是将编织丝21分为经线211和纬线212，经线211为与球囊主体1轴向平行的编织丝，纬线212为沿与球囊主体1的轴向形成夹角的编织丝。其中，经线211根据球囊主体1的大小不同可设置为4～64根编织丝。编织层2以经纬线编织时，可先在球囊主体1进行经线211编织。如图6所示，球囊主体1上编织有经线211，经线211可以均匀分布在球囊主体1的表面，也可以不均匀的分布，用户可根据需求自行设定。经线以不同的编织方式与纬线缠绕在一起，如经纬线平织、经纬线斜织等。如图7和图8所示，编织层2为经纬线通过平织缠绕在一起。经纬线平织编织时，经线211和纬线212相互交错进行编织，经线211与纬线212之间的角度为90°。如图9至图10所示，经纬线斜织编织时经线211始终在中间，纬线212上下交错编织，经线211与纬线212之间的角度为10°～90°；如图11所示，经纬线斜织方式中也可为纬 线212上下交错扭结编织，扭结角度为180°～720°，此处，扭结角度为纬线在球囊主体周向上缠绕的角度。As shown in Figures 6 to 15, the braided layer 2 is configured to be braided by braiding wire 21 with weft or warp and weft. Specifically, the warp and weft weaving method is to divide the braided wire 21 into warp 211 and weft 212, the warp 211 is a braided wire parallel to the axial direction of the balloon body 1, and the weft 212 is a braided wire that forms an angle with the axial direction of the balloon body 1. Among them, the warp 211 can be set to 4 to 64 braided wires according to the size of the balloon body 1. When the braided layer 2 is woven with warp and weft, the warp 211 can be woven on the balloon body 1 first. As shown in Figure 6, the balloon body 1 is woven with warp 211, and the warp 211 can be evenly distributed on the surface of the balloon body 1, or unevenly distributed, and the user can set it according to the needs. The warp is intertwined with the weft in different weaving methods, such as plain weaving of warp and weft, twill weaving of warp and weft, etc. As shown in Figures 7 and 8, the braided layer 2 is the warp and weft intertwined by plain weaving. When the warp and weft are woven in a plain weave, the warp 211 and the weft 212 are interlaced and woven, and the angle between the warp 211 and the weft 212 is 90°. As shown in Figures 9 and 10, when the warp and weft are woven in a twill weave, the warp 211 is always in the middle, and the weft 212 is woven in an up-and-down staggered manner, and the angle between the warp 211 and the weft 212 is 10° to 90°; as shown in Figure 11, the warp and weft can also be woven in a twill weave. The wires 212 are interlaced and twisted up and down, and the twisting angle is 180° to 720°. Here, the twisting angle is the angle at which the weft wires are wound around the circumference of the balloon body.
纬线编织，是指编织的织纹无经线编织，只有纬线，可包括纬线平织、纬线斜织等。如图12所示，纬线平织编织时，纬线212与球囊主体1的轴向成90°编织。如图13至图14所示，纬线斜织编织，纬线212上下交错编织，纬线212之间的角度在10°～180°；或如图15所示，纬线212上下扭结编织，扭结角度在180°～720°。Weft weaving refers to a weaving pattern without warp weaving, only weft, which may include plain weaving of weft, diagonal weaving of weft, etc. As shown in FIG12, when the weft is woven in plain weaving, the weft 212 is woven at 90° to the axial direction of the balloon body 1. As shown in FIG13 to FIG14, the weft is woven in diagonal weaving, the weft 212 is woven in an up-and-down staggered manner, and the angle between the wefts 212 is between 10° and 180°; or as shown in FIG15, the weft 212 is woven in a twisted manner, and the twisting angle is between 180° and 720°.
为进一步确认本发明中的医用球囊可取得的优异效果，如图16所示，将本发明中提供的医用球囊与现有单层球囊进行顺应性对比测试，单层球囊的材料为尼龙，两球囊的尺寸相同。如图16所示，横坐标为压力，单位为atm(大气压强)，纵坐标为直径，单位为mm(毫米)，测试结果表明现有单层球囊的***压力为26atm，且直径随压力的增大变化较大；本发明中提供的医用球囊的耐压性可达50atm，直径随压力的增大相较于现有单层球囊变化小，因此本发明提供的医用球囊的耐压性高，可达50atm，顺应性低。To further confirm the excellent effect that the medical balloon of the present invention can achieve, as shown in Figure 16, the medical balloon provided in the present invention and the existing single-layer balloon were subjected to a compliance comparison test. The material of the single-layer balloon is nylon, and the two balloons have the same size. As shown in Figure 16, the horizontal axis is pressure, the unit is atm (atmospheric pressure), and the vertical axis is diameter, the unit is mm (millimeter). The test results show that the bursting pressure of the existing single-layer balloon is 26atm, and the diameter changes greatly with the increase of pressure; the pressure resistance of the medical balloon provided in the present invention can reach 50atm, and the diameter changes less with the increase of pressure than the existing single-layer balloon. Therefore, the medical balloon provided by the present invention has high pressure resistance, which can reach 50atm, and low compliance.
如图17所示，本发明实施例还提供一种上述的医用球囊的制备方法，包括如下步骤：As shown in FIG. 17 , an embodiment of the present invention further provides a method for preparing the above-mentioned medical balloon, comprising the following steps:
步骤S100：提供一球囊主体1，向球囊主体1内充气；通过在球囊中充气使主体球囊保持一定的形状，便于编织层2的编织，球囊主体的充气压力可为0.5atm-额定压力不等；Step S100: providing a balloon body 1, and inflating the balloon body 1; by inflating the balloon, the main balloon maintains a certain shape, which is convenient for weaving the braided layer 2, and the inflation pressure of the balloon body can be 0.5atm-rated pressure;
步骤S200：提供编织丝21，围绕球囊主体1制作编织层2；编织丝21在进行编织前，可进行加捻或预涂胶等工艺，防止在生产过程中因摩擦等原因导致单丝断裂；Step S200: providing a braided wire 21 to form a braided layer 2 around the balloon body 1; the braided wire 21 may be twisted or pre-coated with glue before braiding to prevent the single wire from breaking due to friction or other reasons during the production process;
步骤S300：通过涂敷工艺(如喷涂、浸涂等)在编织层2的外部制作粘结层3，通过粘结层3将球囊主体1与编织层2固定为一体。Step S300: a bonding layer 3 is made on the outside of the braided layer 2 by a coating process (such as spraying, dipping, etc.), and the balloon body 1 and the braided layer 2 are fixed as a whole by the bonding layer 3.
通过在球囊主体的外部设置编织层，编织层限制在球囊主体充气过程中的膨胀程度，降低了球囊的顺应性，提高了球囊的耐压性；编织层的设置使球囊具有较小的壁厚，提高了球囊的柔顺性；本发明提供的球囊导管工艺简单，成本低。By arranging a braided layer on the outside of the balloon body, the braided layer limits the expansion degree of the balloon body during inflation, reduces the compliance of the balloon, and improves the pressure resistance of the balloon; the arrangement of the braided layer enables the balloon to have a smaller wall thickness, thereby improving the flexibility of the balloon; the balloon catheter provided by the present invention has a simple process and low cost.
具体地，步骤S100还包括如下步骤： Specifically, step S100 also includes the following steps:
在球囊主体2的轴向两端制作两个管脚11和两个锥部12，其中，两个锥部12分别连接两个管脚11与球囊主体1的轴向两端，以使球囊主体1、两个管脚11和两个锥部12一体成型；Two pins 11 and two cones 12 are made at the axial ends of the balloon body 2, wherein the two cones 12 respectively connect the two pins 11 and the axial ends of the balloon body 1, so that the balloon body 1, the two pins 11 and the two cones 12 are integrally formed;
向两个管脚11和两个锥部12内充气。The two pins 11 and the two cones 12 are inflated with air.
具体地，步骤S200还包括：Specifically, step S200 also includes:
围绕两个管脚11和两个锥部12制作编织层2，以使球囊主体1的外侧的编织层2与两个管脚11和两个锥部12的外侧的编织层2一体成型；A braided layer 2 is manufactured around the two pins 11 and the two cones 12, so that the braided layer 2 on the outside of the balloon body 1 is integrally formed with the braided layer 2 on the outside of the two pins 11 and the two cones 12;
具体地，步骤S300还包括：Specifically, step S300 also includes:
通过涂敷工艺在两个管脚11和两个锥部12的外侧制作粘结层3，和/或，通过涂敷工艺在两个管脚11和两个锥部12的外侧的编织层2的外部制作粘结层3。The adhesive layer 3 is formed on the outer sides of the two pins 11 and the two cones 12 by a coating process, and/or the adhesive layer 3 is formed on the outside of the braided layer 2 on the outer sides of the two pins 11 and the two cones 12 by a coating process.
步骤S300还包括：Step S300 also includes:
将粘结剂溶于溶剂中，制作形成粘结溶液，以用于涂敷工艺，其中，粘结剂为热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合；粘结剂在粘结溶液中的浓度为1wt％～20wt％。The binder is dissolved in a solvent to form a binder solution for use in a coating process, wherein the binder is a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate; and the concentration of the binder in the binder solution is 1wt% to 20wt%.
在一些实施例中，溶剂包括四氢呋喃，粘结剂与四氢呋喃的体积比为1:30～1:3。In some embodiments, the solvent includes tetrahydrofuran, and the volume ratio of the binder to the tetrahydrofuran is 1:30 to 1:3.
在另一实施例中，为调节粘结层的成膜速率，溶剂还包括二甲基乙酰胺，二甲基乙酰胺与四氢呋喃的体积比大于0且小于或等于1。In another embodiment, in order to adjust the film-forming rate of the bonding layer, the solvent further includes dimethylacetamide, and the volume ratio of dimethylacetamide to tetrahydrofuran is greater than 0 and less than or equal to 1.
完成超高压球囊部分后，如图18所示，置于管脚11上的编织丝21处于游离状态，需要将两个管脚11处于游离状态的编织丝21固定。进一步地，步骤S300之后，还包括如下步骤S400：After the ultra-high pressure balloon part is completed, as shown in FIG18 , the braided wires 21 placed on the pins 11 are in a free state, and the braided wires 21 of the two pins 11 in a free state need to be fixed. Further, after step S300, the following step S400 is also included:
提供一加强套管6，将加强套管6套设于管脚11外部；通过激光焊接、热风焊接或热合焊接将加强套管6熔融，通过加强套管6将覆于管脚11的外部的编织层2熔融，通过渗透及流动，将编织丝21固定于管脚11上。如图19和图20所示，与内管4靠近一端的游离的编织丝21通过与加强套管6焊接形成焊接区域7。与外管5一端的游离的编织丝21也形成如图20所示的焊接区域7(图中未示出)。A reinforcing sleeve 6 is provided, and the reinforcing sleeve 6 is sleeved on the outside of the tube pin 11; the reinforcing sleeve 6 is melted by laser welding, hot air welding or heat sealing welding, and the braided layer 2 covering the outside of the tube pin 11 is melted through the reinforcing sleeve 6, and the braided wire 21 is fixed to the tube pin 11 through penetration and flow. As shown in Figures 19 and 20, the free braided wire 21 near one end of the inner tube 4 is welded to the reinforcing sleeve 6 to form a welding area 7. The free braided wire 21 at one end of the outer tube 5 also forms a welding area 7 as shown in Figure 20 (not shown in the figure).
如图1所示，本发明实施例还提供了一种球囊导管，包括：As shown in FIG1 , an embodiment of the present invention further provides a balloon catheter, comprising:
如上所述的医用球囊； A medical balloon as described above;
内管4，内管4贯穿球囊主体1的腔体，内管4的远端与球囊主体1的远端相连；以及An inner tube 4, the inner tube 4 passes through the cavity of the balloon body 1, and the distal end of the inner tube 4 is connected to the distal end of the balloon body 1; and
外管5，外管5套设在内管4的外部，外管5的远端与球囊主体1的近端相连。The outer tube 5 is sleeved on the outside of the inner tube 4 , and the distal end of the outer tube 5 is connected to the proximal end of the balloon body 1 .
需要说明的是，当医用球囊还包括管脚和锥部时，内管通过管脚和锥部与球囊主体的远端连接；外管也是通过管脚和锥部与球囊主体的近端相连。It should be noted that when the medical balloon further includes a pin and a cone, the inner tube is connected to the distal end of the balloon body through the pin and the cone; the outer tube is also connected to the proximal end of the balloon body through the pin and the cone.
本发明实施例提供的球囊导管包括如上所述的医用球囊，因此可取得上述医用球囊的所有技术效果，此处不再赘述。The balloon catheter provided in the embodiment of the present invention includes the medical balloon as described above, and thus can achieve all the technical effects of the above-mentioned medical balloon, which will not be described in detail here.
本发明所提供的医用球囊及其制备方法、球囊导管及其制备方法具有如下优点：The medical balloon and its preparation method, balloon catheter and its preparation method provided by the present invention have the following advantages:
编织在球囊主体的外部的编织层限制球囊主体的膨胀，使医用球囊的***压力可达50atm，降低了医用球囊的顺应性；编织层的设置使球囊主体具有较小的复合层壁厚，整体柔顺性好，折叠后的轮廓外径较小，提高了医用球囊的通过性；与现有技术相比，本发明中的医用球囊的制备工艺简单，成本较低。The braided layer woven on the outside of the balloon body limits the expansion of the balloon body, so that the bursting pressure of the medical balloon can reach 50atm, reducing the compliance of the medical balloon; the setting of the braided layer enables the balloon body to have a smaller composite layer wall thickness, good overall flexibility, and a smaller outer diameter of the folded contour, thereby improving the passability of the medical balloon; compared with the prior art, the preparation process of the medical balloon in the present invention is simple and the cost is low.
以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替换，都应当视为属于本发明的保护范围。 The above contents are further detailed descriptions of the present invention in combination with specific preferred embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. For ordinary technicians in the technical field to which the present invention belongs, several simple deductions or substitutions can be made without departing from the concept of the present invention, which should be regarded as falling within the protection scope of the present invention.

Claims (15)

  1. 一种医用球囊，其特征在于，包括：A medical balloon, characterized by comprising:
    球囊主体，所述球囊主体的内部设有轴向贯通的腔体；A balloon body, wherein an axially penetrating cavity is provided inside the balloon body;
    编织层，套设于所述球囊主体的外侧，所述编织层通过编织丝编织而成；A braided layer, which is sleeved on the outer side of the balloon body, and the braided layer is braided by braided wires;
    粘结层，覆于所述球囊主体和/或所述编织层的外侧。The adhesive layer covers the outer side of the balloon body and/or the braided layer.
  2. 根据权利要求1所述的医用球囊，其特征在于，所述医用球囊还包括两个管脚和两个锥部，所述两个管脚分别与所述球囊主体的轴向两端相连通，所述两个锥部分别连接所述两个管脚与所述球囊主体的轴向两端；The medical balloon according to claim 1, characterized in that the medical balloon further comprises two pins and two cones, the two pins are respectively connected to the axial ends of the balloon body, and the two cones are respectively connected to the two pins and the axial ends of the balloon body;
    所述编织层还设置于所述两个管脚和所述两个锥部的外侧；The braided layer is also arranged outside the two pins and the two cones;
    所述粘结层还设置于所述两个管脚和所述两个锥部的外侧，和/或所述粘结层还设置于位于所述两个管脚和所述两个锥部外侧的所述编织层的外侧。The bonding layer is further arranged on the outside of the two pins and the two cones, and/or the bonding layer is further arranged on the outside of the braided layer located outside the two pins and the two cones.
  3. 根据权利要求2所述的医用球囊，其特征在于，所述球囊主体的直径为2mm～12mm，和/或，所述球囊主体的厚度为0.0006英寸～0.002英寸。The medical balloon according to claim 2 is characterized in that the diameter of the balloon body is 2 mm to 12 mm, and/or the thickness of the balloon body is 0.0006 inches to 0.002 inches.
  4. 根据权利要求2所述的医用球囊，其特征在于，所述管脚的外侧的所述编织层的密度和所述锥部的外侧的所述编织层的密度均大于所述球囊主体的外侧的所述编织层的密度。The medical balloon according to claim 2, characterized in that the density of the braided layer on the outside of the pin and the density of the braided layer on the outside of the cone are both greater than the density of the braided layer on the outside of the balloon body.
  5. 根据权利要求1至4任一项所述的医用球囊，其特征在于，所述编织丝的材料为聚对苯二甲酸乙二酯、聚乙烯、聚氨基甲酸酯、不锈钢和镍钛合金中的一种或多种的组合。The medical balloon according to any one of claims 1 to 4 is characterized in that the material of the braided wire is a combination of one or more of polyethylene terephthalate, polyethylene, polyurethane, stainless steel and nickel-titanium alloy.
  6. 根据权利要求1至4任一项所述的医用球囊，其特征在于，所述编织层设置为由所述编织丝以纬线编织或经纬线编织而成。The medical balloon according to any one of claims 1 to 4 is characterized in that the braided layer is configured to be braided by the braided wires in the form of weft or warp and weft.
  7. 根据权利要求1至4任一项所述的医用球囊，其特征在于，所述粘结层是由热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合制成。The medical balloon according to any one of claims 1 to 4, characterized in that the adhesive layer is made of a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate.
  8. 一种根据权利要求1至4任一项所述的医用球囊的制备方法，其 特征在于，包括如下步骤：A method for preparing a medical balloon according to any one of claims 1 to 4, wherein The method is characterized in that it comprises the following steps:
    S100：提供一所述球囊主体，向所述球囊主体内充气；S100: providing a balloon body, and inflating the balloon body;
    S200：提供所述编织丝，围绕所述球囊主体制作所述编织层；S200: providing the braided wire, and making the braided layer around the balloon body;
    S300：通过涂敷工艺在所述编织层的外部制作粘结层，通过所述粘结层将所述球囊主体与所述编织层固定为一体。S300: A bonding layer is made on the outside of the braided layer by a coating process, and the balloon body and the braided layer are fixed as a whole by the bonding layer.
  9. 根据权利要求8所述的医用球囊的制备方法，其特征在于，所述S100还包括：The method for preparing a medical balloon according to claim 8, characterized in that the step S100 further comprises:
    在所述球囊主体的轴向两端制作两个管脚和两个锥部，其中，所述两个锥部分别连接所述两个管脚与所述球囊主体的轴向两端，以使所述球囊主体、所述两个管脚和所述两个锥部一体成型；以及，Two pins and two cones are made at two axial ends of the balloon body, wherein the two cones respectively connect the two pins and the two axial ends of the balloon body, so that the balloon body, the two pins and the two cones are integrally formed; and
    向所述两个管脚和所述两个锥部内充气。The two pins and the two cones are inflated with air.
  10. 根据权利要求9所述的医用球囊的制备方法，其特征在于，The method for preparing a medical balloon according to claim 9, characterized in that:
    所述S200还包括：围绕所述两个管脚和所述两个锥部制作所述编织层，以使所述球囊主体的外侧的所述编织层与所述两个管脚和所述两个锥部的外侧的所述编织层一体成型；The S200 further includes: manufacturing the braided layer around the two pins and the two cones, so that the braided layer on the outside of the balloon body and the braided layer on the outside of the two pins and the two cones are integrally formed;
    所述S300还包括：通过涂敷工艺在两个管脚和所述两个锥部的外侧制作所述粘结层，和/或，通过涂敷工艺在所述两个管脚和所述两个锥部的外侧的所述编织层的外部制作所述粘结层。The S300 further includes: manufacturing the bonding layer on the outer sides of the two pins and the two cones by a coating process, and/or manufacturing the bonding layer on the outside of the braided layer on the outer sides of the two pins and the two cones by a coating process.
  11. 根据权利要求9至10任一项所述的医用球囊的制备方法，其特征在于，所述S300还包括：The method for preparing a medical balloon according to any one of claims 9 to 10, characterized in that the step S300 further comprises:
    将粘结剂溶于溶剂中，制作形成粘结溶液，以用于所述涂敷工艺，其中，所述粘结剂为热塑性聚氨酯、环氧树脂和丙烯酸酯中的一种或多种的组合；Dissolving a binder in a solvent to form a binder solution for use in the coating process, wherein the binder is a combination of one or more of thermoplastic polyurethane, epoxy resin and acrylate;
    所述粘结剂在所述粘结溶液中的浓度为1wt％～20wt％。The concentration of the binder in the binding solution is 1 wt % to 20 wt %.
  12. 根据权利要求11所述的医用球囊的制备方法，其特征在于，所述溶剂包括四氢呋喃，所述粘结剂与所述四氢呋喃的体积比为1:30～1:3。The method for preparing a medical balloon according to claim 11, characterized in that the solvent comprises tetrahydrofuran, and the volume ratio of the binder to the tetrahydrofuran is 1:30 to 1:3.
  13. 根据权利要求12所述的医用球囊的制备方法，其特征在于，所述溶剂还包括二甲基乙酰胺，所述二甲基乙酰胺与所述四氢呋喃的体积比大于0且小于或等于1。The method for preparing a medical balloon according to claim 12, characterized in that the solvent further comprises dimethylacetamide, and the volume ratio of the dimethylacetamide to the tetrahydrofuran is greater than 0 and less than or equal to 1.
  14. 根据权利要求10所述的医用球囊的制备方法，其特征在于，所 述S300之后，还包括如下步骤S400：The method for preparing a medical balloon according to claim 10, characterized in that After S300, the following step S400 is also included:
    提供一加强套管，将所述加强套管套设于所述管脚的外部；Providing a reinforcing sleeve, and sleeve the reinforcing sleeve on the outside of the pin;
    通过激光焊接、热风焊接或热合焊接将所述加强套管熔融，通过所述加强套管将覆于所述管脚的外部的所述编织层及所述粘结层固定于所述管脚上。The reinforcing sleeve is melted by laser welding, hot air welding or heat sealing welding, and the braided layer and the adhesive layer covering the outside of the tube pin are fixed to the tube pin through the reinforcing sleeve.
  15. 一种球囊导管，其特征在于，包括权利要求1至7任一项所述的医用球囊；A balloon catheter, characterized in that it comprises the medical balloon according to any one of claims 1 to 7;
    内管，所述内管贯穿所述球囊主体的所述腔体，所述内管的远端与所述球囊主体的远端相连；以及an inner tube, the inner tube passing through the cavity of the balloon body, the distal end of the inner tube being connected to the distal end of the balloon body; and
    外管，所述外管套设在所述内管的外部，所述外管的远端与所述球囊主体的近端相连。 An outer tube is sleeved on the outside of the inner tube, and the distal end of the outer tube is connected to the proximal end of the balloon body.
PCT/CN2023/139689 2022-12-19 2023-12-19 Medical balloon and preparation method therefor, and balloon catheter WO2024131743A1 (en)

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Publication number Priority date Publication date Assignee Title
CN115970134A (en) * 2022-12-19 2023-04-18 上海博脉安医疗科技有限公司 Medical balloon, preparation method thereof and balloon catheter

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080183132A1 (en) * 2004-10-15 2008-07-31 Futurematrix Interventional, Inc. Non-compliant medical balloon having braided or knitted reinforcement
US20110046654A1 (en) * 2009-08-24 2011-02-24 Shyam Kuppurathanam Textile-reinforced high-pressure balloon
US20150081006A1 (en) * 2013-09-17 2015-03-19 Cook Medical Technologies Llc Medical balloon with varied compliance
US20150320984A1 (en) * 2004-10-15 2015-11-12 Bard Peripheral Vascular, Inc. Non-compliant medical balloon having braided or knitted reinforcement
CN109562247A (en) * 2016-06-14 2019-04-02 波士顿科学国际有限公司 Medical balloon
CN109663202A (en) * 2019-01-17 2019-04-23 南京普微森医疗科技有限公司 A kind of novel cerebrovascular drug sacculus dilating catheter
CN109939336A (en) * 2019-03-12 2019-06-28 杭州巴泰医疗器械有限公司 A kind of belt supporting frame balloon catheter structure for blood vessel dilatation operation
CN110290828A (en) * 2016-12-16 2019-09-27 巴德股份有限公司 Medical balloon, foley's tube and its method
CN110584770A (en) * 2019-09-29 2019-12-20 上海凯利泰医疗科技股份有限公司 High-pressure vertebral body expansion balloon and preparation method thereof
CN114939222A (en) * 2021-02-08 2022-08-26 赛诺神畅医疗科技有限公司 Heart valve sacculus expansion pipe
CN115350383A (en) * 2022-08-30 2022-11-18 铂珑生物科技(苏州)有限公司 Balloon catheter system
CN218793511U (en) * 2022-12-19 2023-04-07 上海博脉安医疗科技有限公司 Medical sacculus and sacculus pipe
CN115970134A (en) * 2022-12-19 2023-04-18 上海博脉安医疗科技有限公司 Medical balloon, preparation method thereof and balloon catheter

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150320984A1 (en) * 2004-10-15 2015-11-12 Bard Peripheral Vascular, Inc. Non-compliant medical balloon having braided or knitted reinforcement
US20080183132A1 (en) * 2004-10-15 2008-07-31 Futurematrix Interventional, Inc. Non-compliant medical balloon having braided or knitted reinforcement
US20110046654A1 (en) * 2009-08-24 2011-02-24 Shyam Kuppurathanam Textile-reinforced high-pressure balloon
US20150352336A1 (en) * 2009-08-24 2015-12-10 Cook Medical Technologies Llc Textile-reinforced high-pressure balloon
US20150081006A1 (en) * 2013-09-17 2015-03-19 Cook Medical Technologies Llc Medical balloon with varied compliance
CN109562247A (en) * 2016-06-14 2019-04-02 波士顿科学国际有限公司 Medical balloon
CN110290828A (en) * 2016-12-16 2019-09-27 巴德股份有限公司 Medical balloon, foley's tube and its method
CN109663202A (en) * 2019-01-17 2019-04-23 南京普微森医疗科技有限公司 A kind of novel cerebrovascular drug sacculus dilating catheter
CN109939336A (en) * 2019-03-12 2019-06-28 杭州巴泰医疗器械有限公司 A kind of belt supporting frame balloon catheter structure for blood vessel dilatation operation
CN110584770A (en) * 2019-09-29 2019-12-20 上海凯利泰医疗科技股份有限公司 High-pressure vertebral body expansion balloon and preparation method thereof
CN114939222A (en) * 2021-02-08 2022-08-26 赛诺神畅医疗科技有限公司 Heart valve sacculus expansion pipe
CN115350383A (en) * 2022-08-30 2022-11-18 铂珑生物科技(苏州)有限公司 Balloon catheter system
CN218793511U (en) * 2022-12-19 2023-04-07 上海博脉安医疗科技有限公司 Medical sacculus and sacculus pipe
CN115970134A (en) * 2022-12-19 2023-04-18 上海博脉安医疗科技有限公司 Medical balloon, preparation method thereof and balloon catheter

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