Perfusion balloon dilatation catheter

Abstract

The invention discloses a perfusion balloon dilatation catheter which comprises a catheter body. The balloon is arranged on the periphery of the tube body in a surrounding mode, the balloon comprises an inner balloon layer facing one side of the tube body and an outer balloon layer backing on one side of the tube body, the inner balloon layer and the outer balloon layer are connected to form a balloon cavity, the extensibility of the inner balloon layer is lower than that of the outer balloon layer, and after the balloon is expanded, the inner balloon layer and the outer balloon layer are connected to form the balloon cavity. A fluid channel is formed between the inner bag layer and the tube body. Due to the fact that the extensibility of the inner balloon layer is lower than that of the outer balloon layer, after the balloon is filled with fluid and expands, the balloon is easier to expand outwards, the deformation expansion degree of the inner balloon layer is smaller than that of the outer balloon layer, and a fluid channel between the inner balloon layer and the catheter body is not prone to being reduced along with expansion of the balloon. And the circulation effect of other fluids such as blood or medicines is not influenced.

Description

Technical Field

[0001] The present application belongs to the field of medical device technology, and specifically relates to a perfusion balloon dilatation catheter. Background Art

[0002] The perfusion balloon dilatation catheter is a special catheter that expands in the human body cavity or blood vessel while maintaining airflow or body fluid circulation. Its perfusion and dilatation functions are achieved thanks to the special structural design of the balloon part with external inflation support and a channel formed in the middle. However, in the prior art, after the balloon is expanded, the balloon becomes larger as a whole, while the middle channel becomes smaller, affecting the effect of blood flow. Summary of the invention

[0003] The present application provides a perfusion balloon dilatation catheter to solve the technical problem that after balloon dilatation, the middle channel narrows and affects the blood flow.

[0004] In order to solve the above technical problems, a technical solution adopted in the present application is: a perfusion balloon dilatation catheter, comprising: a tube body; a balloon, which is arranged around the circumference of the tube body, the balloon includes an inner balloon layer facing the side of the tube body and an outer balloon layer facing away from the side of the tube body, the inner balloon layer and the outer balloon layer are connected to form a balloon cavity, the ductility of the inner balloon layer is lower than the ductility of the outer balloon layer, and after the balloon is inflated, a fluid channel is formed between the inner balloon layer and the tube body.

[0005] According to one embodiment of the present application, the balloon includes a plurality of balloon units arranged in a circular array along the outer circumference of the tube body, each balloon unit includes a balloon body, the balloon body includes an inner balloon edge facing the tube body and an outer balloon edge facing away from the tube body, and an intermediate balloon edge connecting the inner balloon edge and the outer balloon edge, the extensibility of the inner balloon edge is lower than the extensibility of the outer balloon edge, and the inner balloon edges of each of the balloon units are sequentially surrounded to form an inner balloon layer.

[0006] According to one embodiment of the present application, the middle balloon edges of adjacent balloon units fit together, and the extensibility of the middle balloon edges is lower than the extensibility of the outer balloon edges.

[0007] According to one embodiment of the present application, adjacent balloon units share a middle balloon edge.

[0008] According to one embodiment of the present application, the inner capsule edge and the middle capsule edge are made of rigid material, and the outer capsule edge is made of flexible material; or the inner capsule edge, the middle capsule edge and the outer capsule edge are made of the same material, and the thickness of the inner capsule edge and the middle capsule edge is greater than the thickness of the outer capsule edge.

[0009] According to one embodiment of the present application, the rigid material includes nylon or block polyetheramide; and the flexible material includes polyurethane.

[0010] According to one embodiment of the present application, the tube body includes a first tube segment and a second tube segment connected to each other, a through hollow cavity is formed in the first tube segment; the second tube segment is hollow and connected to the hollow cavity, and the balloon is arranged around the outer periphery of the second tube segment.

[0011] According to one embodiment of the present application, the balloon unit also includes a first balloon leg and a second balloon leg, one end of the first balloon leg is connected to an end of the balloon body close to the first tube segment, and the other end extends into the first tube segment and connected to the hollow cavity; one end of the second balloon leg is connected to an end of the balloon body away from the first tube segment, and the other end is connected to the outer wall of the second tube segment to form a closed opening.

[0012] According to one embodiment of the present application, it includes: a woven layer wrapped around the outer periphery of the balloon.

[0013] According to one embodiment of the present application, the braided layer includes a metal braided layer or a suture braided layer.

[0014] The beneficial effects of the present application are: different from the prior art, since the extensibility of the inner balloon layer is lower than that of the outer balloon layer, after the balloon is inflated by the perfusion fluid, the balloon is easier to expand outward, the deformation and expansion degree of the inner balloon layer is less than that of the outer balloon layer, and the fluid channel between the inner balloon layer and the tube body is not easy to decrease with the expansion of the balloon, and does not affect the circulation effect of other fluids such as blood or drugs. The balloon dilatation catheter in the present application can reduce and / or substantially eliminate the occlusion of the fluid channel during the expansion period, thereby allowing a longer balloon expansion and deployment time, eliminating the need for rapid pacing of the heart and related risks, and allowing repositioning during deployment. The balloon dilatation catheter of the present application can achieve excellent results in the fields of heart valves, post-vascular stenosis expansion, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0016] Figure 1 It is a schematic diagram of the overall structure of an embodiment of a perfusion balloon dilatation catheter of the present application;

[0017] Figure 2 It is a schematic cross-sectional structure diagram of an embodiment of a perfusion balloon dilatation catheter of the present application;

[0018] Figure 3It is a schematic diagram of the cross-sectional structure of a balloon unit of an embodiment of a perfusion balloon dilatation catheter of the present application. DETAILED DESCRIPTION

[0019] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. It is to be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some structures related to the present application are shown in the accompanying drawings, rather than all structures. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0020] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0021] In the description of this application, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "plurality" means two or more, unless otherwise clearly and specifically defined.

[0022] In this specification, unless otherwise clearly specified and limited, a first feature being “above” or “below” a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being “above”, “above”, and “above” a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being “below”, “below”, and “below” a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0023] See also Figure 1 and Figure 2 , Figure 1 It is a schematic diagram of the overall structure of an embodiment of a perfusion balloon dilatation catheter of the present application; Figure 2 It is a schematic cross-sectional structure diagram of an embodiment of a perfusion balloon dilatation catheter of the present application.

[0024] The present application provides a perfusion balloon dilatation catheter 100, comprising a tube body 110 and a balloon 120. The balloon 120 is arranged around the outer periphery of the tube body 110. The balloon 120 comprises an inner balloon layer 121 facing the side of the tube body 110 and an outer balloon layer 122 facing away from the side of the tube body 110. The inner balloon layer 121 and the outer balloon layer 122 are connected to surround and form a balloon cavity 123, and the balloon cavity 123 is used to perfuse fluid. After perfusing the fluid, the balloon 120 can be transformed from a contracted state to an expanded state. Among them, the extensibility of the inner balloon layer 121 is lower than the extensibility of the outer balloon layer 122. After the balloon 120 is inflated, a fluid channel 1130 is formed between the inner balloon layer 121 and the tube body 110 for other fluids such as blood or drugs to pass through.

[0025] Since the extensibility of the inner balloon layer 121 is lower than that of the outer balloon layer 122, after the balloon 120 is inflated by the perfusion fluid, the balloon 120 is more likely to expand outward, and the deformation and expansion degree of the inner balloon layer 121 is less than that of the outer balloon layer 122. The fluid channel 1130 between the inner balloon layer 121 and the tube body 110 is not easy to decrease with the expansion of the balloon 120, and does not affect the circulation effect of other fluids such as blood or drugs. The balloon dilatation catheter 100 in the present application can reduce and / or substantially eliminate the occlusion of the fluid channel 1130 during the expansion period, thereby allowing a longer expansion and deployment time of the balloon 120, eliminating the need for rapid pacing of the heart and the related risks, and allowing repositioning during deployment. The balloon dilatation catheter 100 of the present application can achieve excellent results in the field of heart valves, the field of post-stenosis expansion of blood vessels, and the like.

[0026] It should be noted that in the present application, the extensibility of the inner bladder layer 121 and the outer bladder layer 122 is expressed as that after the balloon 120 is perfused and expanded, the expansion degree of the inner bladder layer 121 is less than that of the outer bladder layer 122, and the inner bladder layer 121 expands very little or even does not expand. The comparison of extensibility is a description of the characteristics of the inner bladder layer 121 and the outer bladder layer 122 in this embodiment, and can also be understood as other description methods, including but not limited to properties such as elasticity or hardness. The appropriate description method can be selected according to the selected material. When extensibility is understood as elasticity, the elasticity of the inner bladder layer 121 is lower than the elasticity of the outer bladder layer 122; when extensibility is understood as hardness, the hardness of the inner bladder layer 121 is greater than the hardness of the outer bladder layer 122.

[0027] Please continue reading Figure 3 , Figure 3It is a schematic diagram of the cross-sectional structure of a balloon unit of an embodiment of the perfusion balloon dilatation catheter of the present application. In some embodiments, the balloon 120 includes a plurality of balloon units 124 arranged in a circumferential array along the outer circumference of the tube body 110. Each balloon unit 124 includes a balloon body 125, and the balloon body 125 includes an inner balloon edge 1251 facing the side of the tube body 110 and an outer balloon edge 1252 facing away from the side of the tube body 110, and an intermediate balloon edge 1253 connecting the inner balloon edge 1251 and the outer balloon edge 1252. The intermediate balloon edge 1253 has two corresponding two sides connecting the inner balloon edge 1251 and the outer balloon edge 1252. The ductility of the inner balloon edge 1251 is lower than the ductility of the outer balloon edge 1252. The inner balloon edges 1251 of each balloon unit 124 are sequentially surrounded to form an inner balloon layer 121. The ductility of the inner balloon edge 1251 of each balloon unit 124 is lower than that of the outer balloon edge 1252. After the balloon unit 124 is inflated by the fluid, the balloon unit 124 is more likely to expand toward the outer balloon edge 1252, and the deformation and expansion degree of the inner balloon edge 1251 is lower than that of the outer balloon edge 1252. The inner balloon layer 121 formed by the inner balloon edges 1251 in sequence is not easy to be squeezed inward, and the fluid channel 1130 between the inner balloon edge 1251 and the tube body 110 is not easy to be reduced with the expansion of the balloon 120, and does not affect the circulation effect of other fluids such as blood or drugs.

[0028] Specifically, the inner balloon edges 1251 of adjacent balloon units 124 are interconnected, which limits the position of the balloon unit 124 after expansion, facilitates the outward expansion of each balloon unit 124, and maintains the shape of the fluid channel 1130 without affecting the circulation of other fluids such as blood or drugs.

[0029] Furthermore, the middle capsule edges 1253 of adjacent balloon units 124 are attached to each other, and the extensibility of the middle capsule edge 1253 is lower than the extensibility of the outer capsule edge 1252. Since the extensibility of the middle capsule edge 1253 is lower than the extensibility of the outer capsule edge 1252, the middle capsule edge 1253 plays a certain supporting role in the shape of the balloon 120, guiding the balloon unit 124 to expand toward one side of the outer capsule edge 1252, further avoiding the inner capsule edge 1251 from being squeezed and deformed, and is more conducive to maintaining the shape of the fluid channel 1130, without affecting the circulation effect of other fluids such as blood or drugs.

[0030] Specifically, the middle bag edge 1253 and the inner bag edge 1251 have the same extensibility, so that the middle bag edge 1253 and the inner bag edge 1251 can be made of the same material and manufactured.

[0031] The number of the balloon units 124 is greater than or equal to three, and the inner balloon edges 1251 are used to sequentially surround and form an inner balloon layer 121 , and a fluid channel 1130 can be formed between the inner balloon layer 121 and the tube body 110 .

[0032] Specifically, the number of balloon units 124 can be three, four, five, eight, etc., determined according to actual needs. Taking the number of balloon units 124 as n, the center angle corresponding to each balloon unit 124 after expansion is 360° / n. The two middle balloon edges 1253 of each balloon unit 124 after expansion are outwardly diffused, and the angle between the two middle balloon edges 1253 is 360° / n. For example, when the balloon 120 includes 8 balloon 120 units, n is 8, the center angle corresponding to each balloon unit 124 after expansion is 45°, and the angle between the two middle balloon edges 1253 is 45°.

[0033] In some embodiments, the inner capsule edge 1251, the middle capsule edge 1253 and the outer capsule edge 1252 can achieve different ductility by using different materials. Among them, the inner capsule edge 1251 and the middle capsule edge 1253 are made of rigid materials, and the outer capsule edge 1252 is made of flexible materials. Rigid materials have high hardness, and flexible materials have low hardness. Under the same pressure, rigid materials are not easy to deform, and flexible materials are easy to expand. Therefore, after the balloon unit 124 is inflated by the perfusion fluid, the balloon unit 124 is more likely to expand toward the outer capsule edge 1252 made of flexible material, and the deformation and expansion degree of the inner capsule edge 1251 made of rigid material is less than that of the outer capsule edge 1252, and even the inner capsule edge 1251 does not deform and expand inward.

[0034] Specifically, the rigid material includes nylon (PA), segmented polyether amide (PEBAX) or other materials with relatively high hardness and not easily deformed under pressure. The flexible material includes polyurethane (PU) and other materials with relatively low hardness and relatively easy to expand outward under pressure.

[0035] In other embodiments, the inner bladder edge 1251, the middle bladder edge 1253, and the outer bladder edge 1252 may be made of the same material but with different thicknesses to achieve different extensibility. The thickness of the inner bladder edge 1251 and the middle bladder edge 1253 is greater than the thickness of the outer bladder edge 1252, and the thickness of the inner bladder edge 1251 and the middle bladder edge 1253 is the same. For example, the outer bladder edge 1252 may be made of a single-layer film material, and the inner bladder edge 1251 and the middle bladder edge 1253 may be made of a multi-layer film material.

[0036] The peripheral edges of the inner bag edge 1251, the middle bag edge 1253 and the outer bag edge 1252 can be connected to each other by hot melting or bonding to form a closed space.

[0037] In some embodiments, the balloon dilatation catheter 100 further includes a braided layer 130. The braided layer 130 is wrapped around the outer periphery of the balloon 120. The braided layer 130 wraps the outer side of the balloon 120, which facilitates the delivery of the balloon dilatation catheter 100 in the blood vessel. When the balloon 120 is filled, it expands and expands the outer braided layer 130.

[0038] Specifically, the braided layer 130 may include a metal wire film or a suture film. The braided layer 130 containing metal wires or sutures has a certain strength and can play a role in restraining the balloon 120.

[0039] In some embodiments, the tube body 110 includes a first tube segment 111 and a second tube segment 112 connected to each other. A through hollow cavity is formed in the first tube segment 111. The second tube segment 112 is hollow and communicated with the hollow cavity. The balloon 120 is arranged around the outer periphery of the second tube segment 112. The hollow cavity of the first tube segment 111 can be communicated with the balloon 120 for conveying a perfusion fluid into the balloon 120. A channel independent of the hollow cavity can also be provided in the first tube segment 111 for communicating with the second tube segment 112 for passing other instruments or drugs such as a guide wire.

[0040] In some embodiments, each balloon unit 124 further includes a first balloon leg 126 and a second balloon leg 127. One end of the first balloon leg 126 is connected to one end of the balloon body 125 close to the first tube segment 111, and the other end of the first balloon leg 126 extends into the first tube segment 111 and is connected to the hollow cavity. One end of the second balloon leg 127 is connected to one end of the balloon body 125 away from the first tube segment 111, and the other end is connected to the outer wall of the second tube segment 112 to form a closed opening. Thus, the second balloon leg 127, the balloon body 125 and the first balloon body 125 are sequentially connected to form the balloon unit 124, and an inflation port is formed at the end of the first balloon leg 126, and the first balloon leg 126 is connected to the hollow cavity. Gas can be filled into the balloon unit 124 through the hollow cavity.

[0041] In the above embodiment, the balloon 120 includes a plurality of balloon units 124 arranged in a circumferential array along the outer circumference of the tube body 110. In other embodiments, the balloon 120 may also be annular. The annular balloon 120 includes an inner balloon layer 121 located on the inner side and an outer balloon layer 122 located on the outer layer. The inner balloon layer 121 and the outer balloon layer 122 are connected to each other and surround to form a balloon cavity 123. The ductility of the inner balloon layer 121 is lower than that of the outer balloon layer 122. After the balloon 120 is expanded, a fluid channel 1130 is formed between the inner balloon layer 121 and the tube body 110 for blood or other fluids such as drugs to pass through. Since the extensibility of the inner balloon layer 121 is lower than that of the outer balloon layer 122, after the balloon 120 is inflated by infusing fluid, the balloon 120 is more likely to expand outward, and the deformation and expansion degree of the inner balloon layer 121 is smaller than that of the outer balloon layer 122. The fluid channel 1130 between the inner balloon layer 121 and the tube body 110 is not easy to decrease with the expansion of the balloon 120, and does not affect the circulation effect of other fluids such as blood or drugs.

[0042] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0043] It should be noted that the terms "horizontal", "vertical" and the like do not mean that the components are absolutely horizontal or vertical, but can be slightly tilted; the terms "parallel", "vertical" and the like do not mean that the components are absolutely parallel or vertical, but can form a certain angle deviation. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted. In addition, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate the orientation or position relationship based on the orientation or position relationship shown in the drawings, or the orientation or position relationship in which the product of the present application is usually placed when used, which is only for the convenience of describing the embodiments of the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application.

[0044] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A perfusion balloon dilatation catheter, characterized in that: include: tube body; A balloon is arranged around the outer periphery of the tube body, and the balloon includes an inner balloon layer facing the tube body and an outer balloon layer facing away from the tube body. The inner balloon layer and the outer balloon layer are connected to form a balloon cavity. The ductility of the inner balloon layer is lower than that of the outer balloon layer. After the balloon is inflated, a fluid channel is formed between the inner balloon layer and the tube body.

2. The perfusion balloon dilatation catheter according to claim 1, characterized in that: The balloon includes a plurality of balloon units arranged in a circular array along the outer circumference of the tube body, each balloon unit includes a balloon body, the balloon body includes an inner balloon edge facing the tube body, an outer balloon edge facing away from the tube body, and an intermediate balloon edge connecting the inner balloon edge and the outer balloon edge, the extensibility of the inner balloon edge is lower than the extensibility of the outer balloon edge, and the inner balloon edges of each balloon unit are sequentially surrounded to form an inner balloon layer.

3. The perfusion balloon dilatation catheter according to claim 2, characterized in that: The middle balloon edges of adjacent balloon units are attached to each other, and the extensibility of the middle balloon edges is lower than the extensibility of the outer balloon edges.

4. The perfusion balloon dilatation catheter according to claim 3, characterized in that: The adjacent balloon units share a middle balloon edge.

5. The perfusion balloon dilatation catheter according to claim 3, characterized in that: The inner capsule edge and the middle capsule edge are made of rigid material, and the outer capsule edge is made of flexible material; or the inner capsule edge, the middle capsule edge and the outer capsule edge are made of the same material, and the thickness of the inner capsule edge and the middle capsule edge is greater than the thickness of the outer capsule edge.

6. The perfusion balloon dilatation catheter according to claim 5, characterized in that: The rigid material comprises nylon or segmented polyether amide; the flexible material comprises polyurethane.

7. The perfusion balloon dilatation catheter according to claim 2, characterized in that: The tube body comprises a first tube segment and a second tube segment connected to each other. A through hollow cavity is formed in the first tube segment. The second tube segment is hollow and communicated with the hollow cavity. The balloon is arranged around the outer periphery of the second tube segment.

8. The perfusion balloon dilatation catheter according to claim 7, characterized in that: The balloon unit also includes a first balloon leg and a second balloon leg. One end of the first balloon leg is connected to an end of the balloon body close to the first tube segment, and the other end extends into the first tube segment and is connected to the hollow cavity; one end of the second balloon leg is connected to an end of the balloon body away from the first tube segment, and the other end is connected to the outer wall of the second tube segment to form a closed opening.

9. The perfusion balloon dilatation catheter according to claim 1, characterized in that: include: The braided layer is wrapped around the outer periphery of the balloon.

10. The perfusion balloon dilatation catheter according to claim 9, characterized in that: The braided layer includes a metal wire film or a suture thread film.

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