High-pressure balloon catheter and preparation method therefor
Patent Information
- Application Number
- PCT/CN2026/077517
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-02-19
- Filing Date
- 2026-02-06
- Publication Date
- 2026-08-27
Smart Images
Figure CN2026077517_27082026_PF_FP_ABST
Abstract
Description
High-pressure balloon catheter and its preparation method Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a high-pressure balloon catheter and its preparation method. Background Technology
[0002] High-pressure balloon catheters can be used in at least the following scenarios:
[0003] 1. In the field of surgical valves (e.g., heart valves), there are various implants with different internal design structures. These implants can be made of polymers and / or metals (e.g., stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.) to form a frame or ring structure (e.g., fabric suture ring, conjoint column, tissue leaflet, etc.) to support other components of the implant.
[0004] Using a high-pressure balloon for dilation can cause the structure of a surgical valve (such as a frame or ring structure) to rupture or break, or in other cases, to bend or deform to increase its overall inner diameter so that a new valve can be implanted within it.
[0005] 2. In the field of transcatheter valves (T-ViV), such as those used for the aortic or pulmonary valves of the heart, when the function of an already implanted transcatheter valve declines, a high-pressure balloon catheter can be used to dilate the valve, increasing the overall inner diameter of the valve, and a new transcatheter valve can be implanted inside the valve, ensuring that the effective diameter of the new transcatheter valve is not reduced.
[0006] 3. Severely calcified anatomical structures may form at natural tissue valves or bioprosthetics (such as lung catheters, patches, or stents that have been implanted in previous treatments). Severely calcified anatomical structures are characterized by hard, non-compliant calcified rings that may affect the function of valves or bioprosthetics. High-pressure balloon catheters can be used to destroy the calcified rings, allowing the valves or bioprosthetics to return to normal function.
[0007] While existing high-pressure balloons can be used in the aforementioned fields, their rated rupture pressure (RBP) is usually lower than the required pressure, posing a safety hazard. Summary of the Invention
[0008] Based on this, this application provides a high-pressure balloon catheter with a rated rupture pressure of at least 24 standard atmospheres, which can meet the expansion needs of multiple scenarios such as surgical valves, transcatheter valves, and severely calcified structures.
[0009] A high-pressure balloon catheter includes: a catheter having a distal end and a proximal end, and a balloon body located on the periphery of the distal portion of the catheter body. The outer surface of the balloon body is provided with a reinforcing layer formed by braiding and / or winding high-strength and inelastic fibers. The rated rupture pressure of the balloon catheter is not less than 2.5 MPa.
[0010] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.
[0011] Optionally, the fiber is one of ultra-high molecular weight polyethylene fiber, polyimide fiber, Kevlar fiber, and carbon fiber.
[0012] Optionally, the fibers involved in weaving or winding are continuous fibers.
[0013] Optionally, the outer surface of the balloon body has an anti-slip layer, and the reinforcing layer is in contact with the anti-slip layer.
[0014] Optionally, the anti-slip layer is a first coating layer attached to the outer surface of the balloon, and the material of the first coating layer is one of polyurethane, Kraton, and Pebax.
[0015] Optionally, the anti-slip layer is an anti-slip surface formed by chemically or physically treating the outer surface of the balloon.
[0016] Optionally, the reinforcing layer has a second coating on the side away from the balloon body, and the second coating wets the reinforcing layer.
[0017] Optionally, the material of the second coating is one of Kraton, polycarbonate, or polyurethane.
[0018] Optionally, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0019] First fiber;
[0020] The second fiber and the first fiber are interwoven in a plain weave pattern to form overlapping interlacing points;
[0021] The third fiber extends along the axial direction of the sac body and is alternately located above and below the interlacing point.
[0022] Optionally, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0023] Fourth fiber;
[0024] The fifth fiber, with two adjacent fifth fibers and the fourth fiber overlapping to form multiple channels;
[0025] The sixth fiber surrounds the circumference of the sac and passes through each channel in sequence.
[0026] Optionally, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0027] The seventh fiber;
[0028] The eighth fiber, with two adjacent seventh and eighth fibers intertwined to form multiple connection points;
[0029] The ninth fiber extends along the axial direction of the sac body and is alternately located above and below the hook point.
[0030] Optionally, the balloon body has a reference plane perpendicular to the balloon body axis, and the reinforcing layer includes:
[0031] The tenth fiber is wound around the balloon body to form the first reinforcing layer, and the angle between each winding coil of the first reinforcing layer and the reference plane is less than 15 degrees;
[0032] The eleventh fiber forms a second reinforcing layer by winding it around the balloon body. The angle between each winding coil of the second reinforcing layer and the reference plane is greater than 75 degrees and is an acute angle.
[0033] The first and second reinforcing layers are independently wound together to form a non-interwoven structure, with the first reinforcing layer being closer to the outer surface of the balloon than the second reinforcing layer.
[0034] This application also provides a method for preparing the high-pressure balloon catheter, including weaving and / or winding a reinforcing layer on the surface of the balloon in an inflated state.
[0035] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.
[0036] Optionally, it also includes a pretreatment step performed before the preparation of the reinforcing layer:
[0037] A first solution is applied to the surface of the balloon body. The first solution includes a first polymer with a volume fraction of 3 to 10%, and the first polymer is one of polyurethane, Kraton, and Pebax.
[0038] The first solution is cured and / or evaporated to form a first coating.
[0039] Optionally, it also includes a post-processing step performed after the preparation of the reinforcing layer:
[0040] A second solution is applied to the surface of the second reinforcing layer. The second solution includes a second polymer with a volume fraction of 3-10%, and the second polymer is one of Kraton, polycarbonate, and polyurethane.
[0041] The second solution is cured and / or evaporated to form a second coating.
[0042] The high-pressure balloon catheter provided in this application can withstand at least 24 standard atmospheres of pressure within the balloon. It can be used for expansion in multiple scenarios such as surgical valves, transcatheter valves, and severely calcified structures. It has lower manufacturing costs and higher safety. Attached Figure Description
[0043] Figure 1 is a schematic diagram of the balloon body in this application without a reinforcing layer;
[0044] Figure 2 is a schematic diagram of the use of a balloon catheter;
[0045] Figure 3 is a schematic diagram of the first embodiment of the balloon body with a reinforcing layer in this application;
[0046] Figure 4 is a schematic diagram of the second embodiment of the balloon body with a reinforcing layer in this application;
[0047] Figure 5 is a schematic diagram of the third embodiment of the balloon body with a reinforcing layer in this application;
[0048] Figure 6 is a schematic diagram of the present application where only the first reinforcing layer is provided on the surface of the balloon body;
[0049] Figure 7 is a schematic diagram of a partial second reinforcing layer on the surface of the balloon body in this application;
[0050] Figure 8 is a schematic diagram of the present application where only a second reinforcing layer is provided on the surface of the balloon body;
[0051] Figure 9 is a schematic diagram of the first and second reinforcing layers provided on the surface of the balloon body in this application;
[0052] Figure 10a is a schematic cross-sectional view of the balloon body;
[0053] Figure 10b is a schematic diagram of the cross section along direction AA in Figure 9;
[0054] Figure 11 is a schematic diagram of the folded state of the balloon body during delivery according to this application;
[0055] Figure 12 is a schematic diagram of the equipment for manufacturing high-pressure balloon catheters according to this application.
[0056] In the figure: 100, balloon body; 101, first fiber; 102, second fiber; 103, third fiber; 104, fourth fiber; 105, fifth fiber; 106, sixth fiber; 107, seventh fiber; 108, eighth fiber; 109, ninth fiber; 110, tenth fiber; 111, eleventh fiber; 130, first coating; 140, second coating; 150, reinforcing layer; 151, first reinforcing layer; 152, second reinforcing layer; 210, first drive mechanism; 220, second drive mechanism. Embodiments of the present invention
[0057] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.
[0058] To better describe and illustrate the embodiments of this application, reference may be made to one or more accompanying drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the inventive creations of this application, the embodiments or preferred methods described herein.
[0059] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.
[0060] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
[0061] Referring to Figures 3-5 and Figure 9, a high-pressure balloon catheter includes: a catheter having a distal end and a proximal end, and a balloon body 100 located on the periphery of the distal end of the catheter body. The outer surface of the balloon body 100 is provided with a reinforcing layer 150, which is formed by braiding and / or winding high-strength and non-elastic fibers. The rated rupture pressure of the balloon catheter is not less than 2.5 MPa.
[0062] The reinforcing layer 150 strengthens the balloon wall of the balloon body 100, enabling the balloon body 100 to withstand at least 24 standard atmospheres of pressure. For valves that are not functioning properly, a high-pressure balloon can be used to provide sufficient pressure to expand them, increasing the overall inner diameter of the valve, within which a new transcatheter valve with a sufficient effective opening area can be implanted.
[0063] The reinforcing layer 150 can be formed by fiber weaving, fiber winding, or both weaving and winding structures. The fibers used in weaving or winding are preferably continuous fibers, which have higher tensile strength and are less prone to breakage. When high-pressure fluid is filled into the balloon body 100, stress weak points will not be generated due to fiber breakage.
[0064] The reinforcing layer 150 uses fibers with a tensile strength higher than 18 MPa, preferably between 18 MPa and 35 MPa. The fibers used in the reinforcing layer are non-elastic fibers, meaning the fibers themselves have no elasticity, or their elasticity is negligible. The fibers are one of ultra-high molecular weight polyethylene fibers, polyimide fibers, Kevlar fibers, and carbon fibers.
[0065] Referring to Figure 1, the balloon body 100 is obtained by blow molding. The balloon body 100 has a thin-walled structure and semi-compliant properties (i.e., the balloon diameter increases by 10-15% within the working pressure). The balloon body 100 can be made of nylon 12 material (e.g., Vestamid Care ML21), or medical-grade polymers such as PET and PEBAX. The balloon body 100 serves as a lining for sealing pressure and also acts as a molding die on which other layer structures are fabricated, including but not limited to the reinforcing layer 150.
[0066] To prevent the reinforcing layer 150 from slipping relative to the surface of the balloon body 100 during later use, the outer surface of the balloon body 100 has an anti-slip layer 130, and the reinforcing layer 150 is in contact with the anti-slip layer 130.
[0067] The anti-slip layer 130 is used to increase the friction or bonding force between the surface of the balloon body 100 and the reinforcing layer 150, so that the reinforcing layer 150 is fixed in position relative to the outer surface of the balloon body 100.
[0068] The anti-slip layer 130 is a first coating layer attached to the outer surface of the balloon body 100. The material of the first coating layer is one of polyurethane, Kraton, and Pebax.
[0069] The first coating can form an adhesive coating on the outer surface of the balloon body 100, so that the reinforcing layer 150 is held in place.
[0070] The anti-slip layer 130 is an anti-slip surface formed by chemically or physically treating the outer surface of the balloon body 100.
[0071] The anti-slip layer 130 can also be formed by chemically or physically treating the outer surface of the balloon body 100, for example, by chemically corroding or physically scratching the surface of the balloon body 100.
[0072] A second coating 140 is provided on the side of the reinforcing layer 150 away from the balloon body 100, and the second coating 140 wets the reinforcing layer 150.
[0073] The second coating 140 secures the reinforcing layer 150 to the balloon body 100 and provides a smooth outer surface for the high-pressure balloon catheter to travel smoothly within the target cavity. The second coating 140 is made of one of Kraton, polycarbonate (PCU), or polyurethane (PU).
[0074] Referring to Figure 10a, from the inside to the outside along the radial direction of the balloon body 100, there are, in sequence, an anti-slip layer 130, a reinforcing layer 150, and a second coating layer 140. Figure 10a shows a clear interface for clarity, but in the actual product, the interfaces between the layers may be relatively blurry, especially the second coating layer 140 wetting the reinforcing layer 150.
[0075] As shown in Figure 3, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0076] First fiber 101;
[0077] The second fiber 102 and the first fiber 101 are interwoven in a plain weave manner to form overlapping interlacing points;
[0078] The third fiber 103 extends along the axial direction of the sac body and is alternately located above and below the interlacing point.
[0079] The first fiber 101 and the second fiber 102 form a plain weave structure, that is, the first fiber 101 and the second fiber 102 are stacked alternately, the first fiber 101 and the second fiber 102 are perpendicular to each other, and the angle between the first fiber 101 and the axis of the sac is 30 to 60 degrees.
[0080] The third fiber 103 extends along the axis of the balloon body. Each third fiber 103 has multiple interlacing points along its extension path. The interlacing points along the same path of the third fiber 103 are numbered sequentially. The third fiber 103 is located above the odd-numbered interlacing points and below the even-numbered interlacing points. Above and below are relative concepts. Above is the side of the flat weave structure away from the balloon body, while below is the side of the flat weave structure adjacent to the balloon body. Conversely, if below is the side of the flat weave structure away from the balloon body, then above is the side of the flat weave structure adjacent to the balloon body.
[0081] The first fiber 101, the second fiber 102, and the third fiber 103 are each multiple. The first fiber 101 and the second fiber 102 form a mesh structure, and the multiple third fibers 103 shuttle through the mesh, with a small amount of space for movement within the mesh.
[0082] As shown in Figure 4, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0083] Fourth fiber 104;
[0084] The fifth fiber 105, two adjacent fifth fibers 105 and the fourth fiber 104 overlap to form multiple channels;
[0085] The sixth fiber 106 surrounds the circumference of the sac and passes through each channel in sequence.
[0086] There are multiple fourth fibers 104 and fifth fibers 105, which extend along the axis of the balloon body. Each fourth fiber 104 and fifth fiber 105 is arranged in a wave-like pattern, surrounding the circumference of the balloon body. The fourth fibers 104 and fifth fibers 105 are arranged alternately. The crests of the fourth fiber 104 and the troughs of the adjacent fifth fiber 105 overlap to form a channel, and the troughs of the fourth fiber 104 and the crests of the adjacent fifth fiber 105 overlap to form a channel. The crest of the same fourth fiber 104 overlaps with the trough of an adjacent fifth fiber 105 to form a channel, and the trough of the same fourth fiber 104 overlaps with the crest of another adjacent fifth fiber 105 to form a channel.
[0087] The sixth fiber 106 consists of multiple fibers, which are threaded through the channel. The fourth fiber 104 and the fifth fiber 105 are stacked one above the other to form the channel. The sixth fiber 106 enters the channel above the upper fiber and exits the channel below the lower fiber. The fourth fiber 104, the fifth fiber 105, and the sixth fiber 106 together form a mesh structure. When the sixth fiber 106 is pulled out, the fourth fiber 104 and the fifth fiber 105 separate.
[0088] As shown in Figure 5, the reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include:
[0089] Seventh fiber 107;
[0090] The eighth fiber 108, and the two adjacent seventh fibers 107 and eighth fibers 108 intertwine to form multiple hook points;
[0091] The ninth fiber 109 extends along the axial direction of the sac body, and the ninth fiber 109 is alternately located above and below the hook point.
[0092] The seventh fiber 107 and the eighth fiber 108 extend along the axis of the balloon body. Each seventh fiber 107 and eighth fiber 108 is arranged in a wavy pattern, surrounding the circumference of the balloon body. The seventh fibers 107 and eighth fibers 108 are arranged alternately. The crests of the seventh fiber 107 and the troughs of the adjacent eighth fiber 108 intertwine to form hook points, and the troughs of the seventh fiber 107 and the crests of the adjacent eighth fiber 108 intertwine to form hook points. The crest of the same seventh fiber 107 intertwines with the trough of an adjacent eighth fiber 108 to form a hook point, and the trough of the same seventh fiber 107 intertwines with the crest of another adjacent eighth fiber 108 to form a hook point.
[0093] The ninth fiber 109 consists of multiple fibers. The seventh fiber 107 and the eighth fiber 108 form a stable mesh structure. The ninth fiber 109 is threaded through the mesh. The connection points on the same path of the ninth fiber 109 are numbered sequentially. The ninth fiber 109 is located above the odd-numbered connection points and below the even-numbered connection points.
[0094] Referring to Figures 6, 8, 9, and 10b, a high-pressure balloon catheter includes a balloon body 100. The balloon body 100 has a reference plane perpendicular to its axial direction. The outer surface of the balloon body 100 is provided with:
[0095] The tenth fiber 110 is wound around the balloon body 100 to form a first reinforcing layer 151, and the angle between each winding coil of the first reinforcing layer 151 and the reference plane is less than 15 degrees.
[0096] The eleventh fiber 111 is wound around the balloon body 100 to form a second reinforcing layer 152, wherein each winding coil of the second reinforcing layer 152 has an angle greater than 75 degrees with the reference plane and is an acute angle.
[0097] The first reinforcing layer 151 and the second reinforcing layer 152 are independently wound and form a non-interwoven structure.
[0098] The first reinforcing layer 151 and the second reinforcing layer 152 are formed by independent winding. The tenth fiber 110 and the eleventh fiber 111 are only in contact with each other, but do not have a relationship of weaving, interlacing or entanglement.
[0099] The first reinforcing layer 151 and the second reinforcing layer 152 reinforce the balloon wall of the balloon body 100, enabling the balloon body 100 to withstand at least 24 standard atmospheres of pressure. For valves that are not functioning properly, a high-pressure balloon can be used to provide sufficient pressure to expand them, thereby increasing the overall inner diameter of the valve, into which a new transcatheter valve with a sufficient effective opening area can be implanted.
[0100] The tenth fiber 110 and the eleventh fiber 111 have different winding directions. The winding coils of the tenth fiber 110 layer are wound around the circumference of the balloon body 100, and the formed winding coils are approximately parallel to the reference plane. The first reinforcing layer 151 restricts the radial expansion of the balloon body 100 and increases the radial support. The winding coils of the eleventh fiber 111 are wound around the axial direction of the balloon body 100, and the formed winding coils are approximately perpendicular to the reference plane. The second reinforcing layer 152 restricts the axial expansion of the balloon body 100 and increases the axial support.
[0101] The first reinforcing layer 151 and the second reinforcing layer 152 provide effective radial and axial support for the balloon body 100, respectively. When the balloon body 100 is filled with fluid at a high pressure, the first reinforcing layer 151 and the second reinforcing layer 152 bear the pressure and prevent the balloon body 100 from rupturing. At the same time, the first reinforcing layer 151 and the second reinforcing layer 152 are independent of each other and do not require complex mechanical equipment such as weaving and interlacing, resulting in lower manufacturing costs. Moreover, they avoid the problem of excessively large contour dimensions at the end of the balloon body 100 caused by the weaving structure.
[0102] The reference plane is represented by a dashed line in Figures 6 and 7, and the angle α between each winding coil of the first reinforcing layer 151 and the reference plane is less than 15 degrees. More preferably, the angle α between each winding coil of the first reinforcing layer 151 and the reference plane is less than 10 degrees. More preferably, the angle α between each winding coil of the first reinforcing layer 151 and the reference plane is less than 5 degrees.
[0103] The eleventh fiber 111 forms a second reinforcing layer 152 wound around the balloon body 100. The angle β between each winding coil of the second reinforcing layer 152 and the reference plane is greater than 75 degrees and is an acute angle. Since the balloon body 100 has a three-dimensional structure and radially constricted ends, the winding coils of the second reinforcing layer 152 are not strictly in the same plane. However, in the cylindrical main body of the balloon body 100, the winding coils formed by each eleventh fiber 111 can be distinguishably located in different planes. More preferably, the angle β between each winding coil of the second reinforcing layer 152 and the reference plane is greater than 80 degrees and is an acute angle. More preferably, the angle β between each winding coil of the second reinforcing layer 152 and the reference plane is greater than 85 degrees and is an acute angle.
[0104] The tenth fiber 110 and the eleventh fiber 111 serve as reinforcements and need to have sufficient strength. The tenth fiber 110 and the eleventh fiber 111 are made of ultra-high molecular weight polyethylene.
[0105] The tenth fiber 110 and the eleventh fiber 111 are each at least one continuous fiber.
[0106] Continuous fibers have a large aspect ratio and are uninterrupted and spliced along their length. Continuous fibers have higher tensile strength and will not break under large tensile forces.
[0107] The tenth fiber 110 and the eleventh fiber 111 can be a single continuous fiber or a fiber cluster composed of multiple continuous fibers.
[0108] The balloon body 100 includes a main body and a neck that extends along the axis of the main body and gradually tapers at the end. The tenth fiber 110 and the eleventh fiber 111 are wrapped around the main body and the neck to fully cover the outer surface of the balloon body 100 for reinforcement, so as to avoid the balloon body 100 from being locally exposed due to the lack of a reinforcing layer during the pressurization process, thus forming a weak part.
[0109] The structure of the first reinforcing layer 151 is shown in Figure 6. In the first reinforcing layer 151, the winding coil formed by the tenth fiber 110 is approximately parallel to the reference plane (i.e., the cross-section of the balloon body 100). The tenth fiber 110 is used to restrain the radial expansion of the balloon body 100.
[0110] The structure of the second reinforcing layer 152 is shown in Figures 7 and 8. In Figure 7, the eleventh fiber 111 is partially wound, and in Figure 8, the eleventh fiber 111 is fully wound. The winding coil formed by the eleventh fiber 111 is approximately perpendicular to the reference plane (i.e., the cross-section of the balloon body 100). The eleventh fiber 111 is used to restrain the axial expansion of the balloon body 100.
[0111] In Figures 6, 7 and 8, for clarity of structural representation, the tenth fiber 110 and the eleventh fiber 111 are sparser than in the actual product, while the actual arrangement of the tenth fiber 110 and the eleventh fiber 111 is denser.
[0112] The thickness of the first reinforcing layer is 0.01mm~0.05mm, and the thickness of the second reinforcing layer is 0.01mm~0.05mm.
[0113] In the first reinforcing layer 151, the spacing between two adjacent winding coils is 0~20mm, preferably 0.1~0.3mm, and most preferably 0.15~0.2mm. In the second reinforcing layer 152, the spacing between two adjacent winding coils is 0~20mm, preferably 0.1~2mm, and most preferably 0.2~0.6mm.
[0114] The first reinforcing layer 151 is closer to the outer surface of the balloon body 100 than the second reinforcing layer 152. That is, the tenth fiber 110 is first wound around the outer surface of the balloon body 100, and after the tenth fiber 110 is wound, the eleventh fiber 111 is wound around it.
[0115] Referring to Figure 10b, along the radial direction of the balloon body 100 from the inside to the outside, there are, in sequence, an anti-slip layer 130, a first reinforcing layer 151, a second reinforcing layer 152, and a second coating layer 140. For clarity, Figure 10b shows a clear interface, but in the actual product, the interfaces between the layers may be relatively blurred, especially since the second coating layer 140 wets the second reinforcing layer 152, or the second coating layer 140 simultaneously wets the first reinforcing layer 151 and the second reinforcing layer 152.
[0116] The second coating 140 wets the contact surface between the second reinforcing layer 152 and the first reinforcing layer 151. The second coating 140 fixes the first reinforcing layer 151 and the second reinforcing layer 152 together, prevents the migration of the tenth fiber 110 and the eleventh fiber 111, and provides a smooth outer surface for the high-pressure balloon catheter to travel smoothly in the target cavity.
[0117] As shown in Figure 11, after the balloon body 100 and its layers are prepared, during the process of being transported to the target location, the balloon body 100 and its layers are folded and rolled up, and then inflated by fluid after entering the target location.
[0118] Referring to Figures 1 to 9, the balloon body 100 is in an inflated state. The balloon body 100 is obtained by blow molding. The size of the balloon body 100 and the blow molding process can adopt existing technologies.
[0119] This application also provides a method for preparing the high-pressure balloon catheter, including weaving and / or winding a reinforcing layer on the surface of the balloon in an inflated state.
[0120] The method for preparing a high-pressure balloon catheter also includes a pretreatment step performed before preparing the reinforcing layer.
[0121] A first solution is applied to the surface of the balloon body. The first solution includes a first polymer with a volume fraction of 3 to 10%, and the first polymer is one of polyurethane, Kraton, and Pebax.
[0122] The first solution is cured and / or evaporated to form a first coating.
[0123] The first solution is applied to the surface of the balloon body 100 by spraying or dipping. The first solution has a low concentration. After the first solution is applied, it begins to solidify and / or evaporate at room temperature, becoming viscous after 5-10 minutes.
[0124] The method for fabricating a high-pressure balloon catheter also includes a post-processing step performed after the preparation of the reinforcing layer.
[0125] A second solution is applied to the surface of the second reinforcing layer. The second solution includes a second polymer with a volume fraction of 3-10%, and the second polymer is one of Kraton, polycarbonate, and polyurethane.
[0126] The second solution is cured and / or evaporated to form a second coating.
[0127] The second solution is applied to the surface of the reinforcing layer 150 by either dip coating or spraying. The second solution has a low concentration. After application, it penetrates the reinforcing layer 150 and cures and / or evaporates at room temperature, bonding the reinforcing layer 150 and forming a smooth outer surface.
[0128] This application also provides a method for preparing a high-pressure balloon catheter, comprising the following steps:
[0129] Step 1: The tenth fiber 110 is wound circumferentially around the surface of the inflated balloon 100 to form a first reinforcing layer 151;
[0130] Step 2: The eleventh fiber 111 is used to axially wind around the outside of the first reinforcing layer 151 to form a second reinforcing layer 152.
[0131] The process of step 1 is shown in Figure 6. The tenth fiber 110 is wound around the surface of the balloon body 100 in the direction indicated by the arrow in the figure to form a first reinforcing layer 151. The process of step 2 is shown in Figures 7 and 8. The eleventh fiber 111 is wound around the first reinforcing layer 151 in the direction indicated by the arrow in the figure to form a second reinforcing layer 152. Figure 7 shows the eleventh fiber 111 partially wound, and Figure 8 shows the state after the eleventh fiber 111 is fully wound. The first reinforcing layer 151 is omitted in Figures 7 and 8.
[0132] Figure 9 shows the state after the first reinforcing layer 151 and the second reinforcing layer 152 are fully wound. For clarity, the winding of the tenth fiber 110 and the eleventh fiber 111 in Figure 9 is sparser than that of the actual product.
[0133] Referring to Figure 12, this application also provides a processing apparatus for a high-pressure balloon catheter, the processing apparatus comprising:
[0134] A first drive mechanism 210 that drives the balloon body 100 to rotate about its axis;
[0135] A second drive mechanism 220 moves linearly along the axis of the balloon body 100 to wind fibers onto the balloon body 100.
[0136] The first drive mechanism 210 clamps both ends of the balloon body 100 along its axial direction, causing the balloon body 100 to rotate continuously around its axis, while the second drive mechanism 220 moves linearly along the axis of the balloon body 100 (in the direction indicated by the double arrows in the figure).
[0137] When the tenth fiber 110 is wound, the first drive mechanism 210 drives the balloon body 100 to rotate, and the second drive mechanism 220 moves at a relatively slow speed in a straight line, so that the tenth fiber 110 is wound around the circumference of the balloon body 100 at small intervals.
[0138] When the eleventh fiber 111 is wound, the first drive mechanism 210 drives the balloon body 100 to rotate, and the second drive mechanism 220 moves faster in a straight line. When the balloon body 100 rotates around the axis once, the second drive mechanism 220 completes one round trip at both ends of the axial direction of the balloon body 100, that is, the balloon body 100 rotates around the axis once, and the eleventh fiber 111 forms a complete winding coil on the balloon body 100.
[0139] The tenth fiber 110 and the eleventh fiber 111 can be made of the same material. That is, by adjusting the rotation speed of the first drive mechanism 210 and the linear motion speed of the second drive mechanism 220, the winding of the tenth fiber 110 and the winding of the eleventh fiber 111 can be switched.
[0140] It also includes a fiber supply measurement mechanism, which continuously measures the amount of fiber wrapped around the balloon body 100 to ensure that the fiber maintains a consistent tension during winding.
[0141] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0142] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. A high-pressure balloon catheter, comprising: A catheter having a distal and a proximal end, and a balloon body located on the periphery of the distal portion of the catheter body, characterized in that the outer surface of the balloon body is provided with a reinforcing layer formed by braiding and / or winding high-strength and inelastic fibers, and the rated rupture pressure of the balloon catheter is not less than 2.5 MPa.
2. The high-pressure balloon catheter according to claim 1, characterized in that, The fiber is one of ultra-high molecular weight polyethylene fiber, polyimide fiber, Kevlar fiber, and carbon fiber.
3. The high-pressure balloon catheter according to claim 1, characterized in that, The fibers involved in weaving or winding are continuous fibers.
4. The high-pressure balloon catheter according to claim 1, characterized in that, The outer surface of the balloon has an anti-slip layer, and the reinforcing layer is in contact with the anti-slip layer.
5. The high-pressure balloon catheter according to claim 4, characterized in that, The anti-slip layer is a first coating layer attached to the outer surface of the balloon, and the material of the first coating layer is one of polyurethane, Kraton, and Pebax.
6. The high-pressure balloon catheter according to claim 4, characterized in that, The anti-slip layer is an anti-slip surface formed by chemically or physically treating the outer surface of the balloon.
7. The high-pressure balloon catheter according to claim 1, characterized in that, The reinforcing layer has a second coating on the side away from the balloon body, and the second coating wets the reinforcing layer.
8. The high-pressure balloon catheter according to claim 7, characterized in that, The material of the second coating is one of Kraton, polycarbonate, or polyurethane.
9. The high-pressure balloon catheter according to any one of claims 1 to 8, characterized in that, The reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include: First fiber; The second fiber and the first fiber are interwoven in a plain weave pattern to form overlapping interlacing points; The third fiber extends along the axial direction of the sac body and is alternately located above and below the interlacing point.
10. The high-pressure balloon catheter according to any one of claims 1 to 8, characterized in that, The reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include: Fourth fiber; The fifth fiber, with two adjacent fifth fibers and the fourth fiber overlapping to form multiple channels; The sixth fiber surrounds the circumference of the sac and passes through each channel in sequence.
11. The high-pressure balloon catheter according to any one of claims 1 to 8, characterized in that, The reinforcing layer is formed by fiber weaving, and the fibers involved in the weaving include: The seventh fiber; The eighth fiber, with two adjacent seventh and eighth fibers intertwined to form multiple connection points; The ninth fiber extends along the axial direction of the sac body and is alternately located above and below the hook point.
12. The high-pressure balloon catheter according to any one of claims 1 to 8, characterized in that, The balloon body has a reference plane perpendicular to the balloon body axis, and the reinforcing layer includes: The tenth fiber is wound around the balloon body to form the first reinforcing layer, and the angle between each winding coil of the first reinforcing layer and the reference plane is less than 15 degrees; The eleventh fiber forms a second reinforcing layer by winding it around the balloon body. The angle between each winding coil of the second reinforcing layer and the reference plane is greater than 75 degrees and is an acute angle. The first and second reinforcing layers are independently wound together to form a non-interwoven structure, with the first reinforcing layer being closer to the outer surface of the balloon than the second reinforcing layer.
13. A method for preparing a high-pressure balloon catheter as described in any one of claims 1 to 12, characterized in that, This includes weaving and / or winding to form a reinforcing layer on the surface of the balloon in its inflated state.
14. The method for preparing the high-pressure balloon catheter according to claim 13, characterized in that, Also includes: Pretreatment steps performed before fabricating the reinforcing layer: A first solution is applied to the surface of the balloon body. The first solution includes a first polymer with a volume fraction of 3 to 10%, and the first polymer is one of polyurethane, Kraton, and Pebax. The first solution is cured and / or evaporated to form a first coating.
15. The method for preparing the high-pressure balloon catheter according to claim 13, characterized in that, Also includes: Post-processing steps performed after the preparation of the reinforcing layer: A second solution is applied to the surface of the second reinforcing layer. The second solution includes a second polymer with a volume fraction of 3-10%, and the second polymer is one of Kraton, polycarbonate, and polyurethane. The second solution is cured and / or evaporated to form a second coating.