Balloon and balloon dilatation catheter

Abstract

The application discloses a balloon and a balloon dilatation catheter, and relates to the technical field of medical devices. The balloon comprises a balloon main body, a guide piece, a pressure-resistant sleeve and a control knob. The guide piece is arranged at the distal end of the balloon main body. The pressure-resistant sleeve is movably switched between a first position and a second position and is sleeved on the guide piece. When the pressure-resistant sleeve is in the first position, the pressure-resistant sleeve is sleeved on the outer periphery of the guide piece. When the pressure-resistant sleeve is in the second position, the pressure-resistant sleeve is sleeved on the outer periphery of the balloon main body. The control knob is connected with the pressure-resistant sleeve and is used for controlling the switching of the pressure-resistant sleeve between the first position and the second position. The application improves the structure of the balloon, reduces the thickness of the balloon, makes the balloon more foldable and coiled, improves the passability of the balloon in blood vessels, reduces the difficulty of operation, and enables the balloon to resist higher pressure.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon and a balloon dilatation catheter. BACKGROUND

[0002] Balloon dilatation catheter is one of the most widely used medical devices in vascular intervention treatment, which is used for treating vascular stenosis or occlusion. The principle is to insert the balloon catheter into the stenosis part of the blood vessel through percutaneous puncture technology, and to dilate the balloon under the guidance of medical imaging equipment, so as to expand the stenosis part of the blood vessel and restore to normal lumen diameter. Compared with surgical operation, balloon dilatation technology has the advantages of simple operation, small trauma, few complications, repeatable operation, and rapid postoperative recovery, high safety and reliability.

[0003] The rated burst pressure of the existing balloon is usually between 8-24 atm, however, for some serious calcification, heavy plaque load or long-term chronic occlusion lesions, higher rated burst pressure (more than 24 atm) is often needed to expand the lesions. In order to improve the pressure resistance of the balloon, the common method at present is to weave fibers onto the outer surface of the balloon by using a braiding machine, and to coat a thick glue to fix the fiber mesh on the balloon. This method not only increases the thickness of the balloon, but also increases the overall hardness of the balloon and occupies a large volume, which affects the folding and winding process of the balloon, reduces the passability of the balloon in the blood vessel, and increases the difficulty of the operation process. SUMMARY

[0004] The main purpose of the present application is to provide a balloon and a balloon dilatation catheter, which aims to reduce the thickness of the balloon, improve the folding and winding ability of the balloon, improve the passability of the balloon in the blood vessel, reduce the difficulty of the operation, and at the same time make the balloon can withstand higher pressure.

[0005] To achieve the above purpose, the present application provides a balloon, which comprises:

[0006] a balloon body;

[0007] a guide piece arranged at the distal end of the balloon body;

[0008] a pressure-resistant sleeve movably switched between a first position and a second position on the guide piece; when in the first position, the pressure-resistant sleeve is sleeved on the outer periphery of the guide piece, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the guide piece and a small part is sleeved on the outer periphery of the balloon body; when in the second position, the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body and a small part is sleeved on the outer periphery of the guide piece; and

[0009] A control element is connected to the pressure-resistant sleeve, and the control element is used to control the pressure-resistant sleeve to switch between the first position and the second position.

[0010] Optionally, the pressure-resistant sleeve is a fiber mesh, and the fiber mesh is a high-strength fiber composed of one or more of the following materials: poly(p-phenylene terephthalamide) fiber, aromatic polyamide copolymer fiber, heterocyclic polyamide fiber, carbon fiber, graphite fiber, and silicon carbide fiber.

[0011] Optionally, the control element is a traction wire, line, rope, or rod.

[0012] Optionally, the control element has two parts, one end of each control element is connected to the proximal end of the pressure-resistant sleeve and the connection point of the two parts is located at both ends of the diameter of the pressure-resistant sleeve, and the other end of the control element is a controlled end and is adapted to be located outside the body.

[0013] Optionally, the main body of the balloon is a polymer material, which includes at least one of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, and polyethylene terephthalate.

[0014] Optionally, the guide member is a solid column or a hollow tube; one end of the guide member is connected to the distal end of the balloon body, and the other end of the guide member extends in a direction opposite to the axial direction of the balloon body; or

[0015] The guide is an inner tube that penetrates the balloon body and communicates with the inner cavity of the balloon body.

[0016] Optionally, when the guide is the inner tube, the inner cavity of the inner tube is a guide wire cavity for guide wire insertion.

[0017] Optionally, the portion of the inner tube located within the inner cavity of the balloon body is provided with a imaging section, which is used to make the balloon visible under image detection light.

[0018] To achieve the above objectives, the present invention also provides a balloon dilation catheter, comprising:

[0019] The balloon as described above;

[0020] An external catheter, the distal end of which is connected to the proximal end of the balloon; and

[0021] A catheter hub is fixed to the proximal end of the external catheter;

[0022] The balloon includes:

[0023] The main body of the balloon;

[0024] A guide element is located at the distal end of the balloon body;

[0025] a pressure-resistant sleeve movably switched between a first position and a second position on the guide; in the first position, the pressure-resistant sleeve is sleeved on the outer periphery of the guide, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the guide and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body; in the second position, the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the guide; and

[0026] a control connected with the pressure-resistant sleeve, the control being used to control the switching of the pressure-resistant sleeve between the first position and the second position.

[0027] Optionally, the outer catheter is sleeved on the outer periphery of the guide and surrounds the guide to form a filling cavity, the guide of the balloon is an inner lumen tube with a guide wire cavity, and the catheter seat is provided with a filling port in communication with the filling cavity and a guide wire port in communication with the proximal end of the guide.

[0028] In the technical scheme of the present application, the balloon comprises a balloon body, a guide, a pressure-resistant sleeve and a control; the guide is arranged at the distal end of the balloon body; the pressure-resistant sleeve is movably switched between a first position and a second position on the guide; in the first position, the pressure-resistant sleeve is sleeved on the outer periphery of the guide, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the guide and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body; in the second position, the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the guide; the control is connected with the pressure-resistant sleeve, and the control is used to control the switching of the pressure-resistant sleeve between the first position and the second position. In the initial state, the balloon body is in the folded and contracted state, the pressure-resistant sleeve is folded on the guide at the distal end of the balloon body, the proximal end of the pressure-resistant sleeve is connected with the control, and the control extends to the outside of the body for the operator to control. After the balloon is delivered to the target position, the operator controls the control to pull the pressure-resistant sleeve to the outer periphery of the balloon body and wrap the balloon body. When the operator feels obvious resistance, the pressure-resistant sleeve covers the entire balloon body. Then, the balloon body is inflated. Since the outer side of the balloon body is restrained by the pressure-resistant sleeve, the deformation of the balloon body during the inflation process is limited, so that the balloon body can withstand higher pressure without rupture. After the balloon body is inflated, the stenosis lesion is expanded, and then the balloon body is deflated and contracted. Finally, the balloon is withdrawn from the body. It can be understood that the present application improves the structure of the balloon, reduces the overall thickness of the balloon during delivery, improves the passability of the balloon in the blood vessel, and makes the balloon easier to fold and wind, thereby reducing the difficulty of operation. At the same time, it is ensured that the balloon body can withstand higher pressure. BRIEF DESCRIPTION OF DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings described below only show some of the embodiments of the present application, and all other drawings obtained by those of ordinary skill in the art without creative effort based on these drawings also belong to the protection scope of the present application.

[0030] Figure 1 Structure schematic view of the pressure-resistant sleeve in the first position in one embodiment of the present application;

[0031] Figure 2 Structure schematic view of the pressure-resistant sleeve in the second position in one embodiment of the present application;

[0032] Figure 3 Structure schematic view of the pressure-resistant sleeve in the second position and after the balloon body is inflated in one embodiment of the present application;

[0033] Figure 4 Structure schematic view of the pressure-resistant sleeve in the second position in one embodiment of the balloon dilatation catheter of the present application.

[0034] Explanation of the reference signs:

[0035] 10, balloon body; 20, guide; 30, pressure-resistant sleeve; 40, control; 201, developing part; 50, outer catheter; 60, catheter seat; 60a, inflation port; 60b, guide wire port.

[0036] The implementation, functional features and advantages of the present application will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative effort belong to the protection scope of the present application.

[0038] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present application are only used to explain the relative position relationship, movement condition, etc. between the components in a certain posture (as shown in the drawings), and if the certain posture changes, the directional indications also change accordingly.

[0039] In the description of the present application, it should be explained that, unless otherwise explicitly specified and limited, the terms "mounting", "connection", "linking" should be understood in a broad sense, for example, it can be fixed connection, or detachable connection, or integrally connected; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through intermediate medium, or the internal communication of two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0040] In addition, the description involving "first", "second" and the like in the present application is only for the purpose of description, and cannot be understood as indicating or implying the relative importance of the indicated technical features or implicitly indicating the number of the indicated technical features. Therefore, the features limited by "first" and "second" can explicitly or implicitly include at least one of the features. The meaning of "and / or" appearing throughout the text is to include three parallel schemes, for example, "A and / or B" includes A scheme, or B scheme, or A and B schemes. The technical solutions of various embodiments can be combined with each other, but it must be based on the realization of those skilled in the art, when the combination of technical solutions appears contradictory or unachievable, it should be considered that the combination of technical solutions does not exist, and is not within the protection scope required by the present application.

[0041] The present application provides a high-pressure thin-walled film-coated balloon.

[0042] Reference Figures 1 to 3 In an embodiment of the present application, the balloon includes a balloon body 10, a guide 20, a pressure-resistant sleeve 30, and a control 40; the guide 20 is arranged at the distal end of the balloon body 10; the pressure-resistant sleeve 30 is movably switched between a first position and a second position on the guide 20; when in the first position, the pressure-resistant sleeve 30 is entirely sleeved on the outer periphery of the guide 20, or most of the pressure-resistant sleeve 30 is sleeved on the outer periphery of the guide 20, and a small part is sleeved on the outer periphery of the balloon body 10; when in the second position, the pressure-resistant sleeve 30 is entirely sleeved on the outer periphery of the balloon body 10, or most of the pressure-resistant sleeve 30 is sleeved on the outer periphery of the balloon body 10, and a small part is sleeved on the outer periphery of the guide 20; the control 40 is connected with the pressure-resistant sleeve 30, and the control 40 is used to control the pressure-resistant sleeve 30 to switch between the first position and the second position.

[0043] In the embodiment, the balloon body 10 is made of a high polymer material, which includes at least one of polyvinyl chloride (PVC), polyethylene (PE), polyurethane (TPU), polyamide (Nylon), polyether block polyamide (Pebax), and polyethylene terephthalate (PET), etc., which is not limited herein.

[0044] The guide 20 can be a solid columnar structure or a hollow tubular structure, etc., which can allow the pressure-resistant sleeve 30 to slide, which is not limited herein.

[0045] The pressure-resistant sleeve 30 can be a hollow fiber mesh or a non-hollow sleeve structure, has a certain elasticity, can expand with the expansion of the balloon main body 10, and has strong high-pressure resistance. The structure and material thereof are not limited.

[0046] The control member 40 can be a traction wire, a line, a rope, or a rod, and the like, which is not limited. The control member 40 can be designed as a structure manually pulled for control, or can be designed as a structure driven by a motor or the like for automatic control of the movement, which is not limited.

[0047] In the initial state, the balloon main body 10 is in a folded and contracted state, the pressure-resistant sleeve 30 is folded on the guide 20 at the distal end of the balloon main body 10, the proximal end of the pressure-resistant sleeve 30 is connected to the control member 40, and the control member 40 extends to the outside of the body for the operator to control. After the balloon is delivered to the target position, the operator can control the proximal end of the control member 40 to pull the pressure-resistant sleeve 30 to the outer periphery of the balloon main body 10 and wrap it on the balloon main body 10. When the operator feels obvious resistance, the pressure-resistant sleeve 30 just covers the entire balloon main body 10, and then the balloon main body 10 is inflated. Since the outside of the balloon main body 10 is restrained by the pressure-resistant sleeve 30, the deformation amount of the balloon main body 10 is limited during the inflation process, so that the balloon main body 10 can withstand higher pressure without rupture. After the balloon main body 10 is inflated, the stenosis lesion is expanded, and then the balloon main body 10 is depressurized and contracted. Finally, the balloon is withdrawn from the body.

[0048] It can be understood that the present application improves the structure of the balloon, reduces the overall thickness of the balloon during delivery, improves the passability of the balloon in the blood vessel, and makes the balloon easier to fold and wind, thereby reducing the difficulty of operation. At the same time, it is ensured that the balloon main body 10 can withstand higher pressure.

[0049] In order to reduce the volume of the pressure-resistant sleeve 30 and improve the deformability and pressure resistance of the pressure-resistant sleeve 30, in an embodiment, referring to Figures 1 to 3 , the pressure-resistant sleeve 30 can be a fiber mesh. The material of the fiber mesh can be one or more of the following materials: poly-p-phenylene terephthalamide fiber, aromatic polyamide copolymer fiber, heterocyclic polyamide fiber, carbon fiber, graphite fiber, and silicon carbide fiber.

[0050] In an embodiment, referring to Figures 1 to 3 , the control member 40 can be preferably two traction lines. One end of each of the two traction lines is connected to the proximal end of the pressure-resistant sleeve 30, and the connection points of the two traction lines are located at the two ends of the diameter of the pressure-resistant sleeve 30. The other end of each of the two traction lines is a controlled end and is adapted to be located outside the body. In this way, the structure of the balloon can be simplified as much as possible, which is helpful to reduce the cost of the product.

[0051] In the embodiment, the controlled ends of the two traction lines can be free ends for direct control by the operator. Of course, the two traction lines can also be drivingly connected with a motor or the like driving member, and the traction lines are automatically controlled to be wound or unwound by the motor, so as to drive the pressure-resistant sleeve 30 to move in the axial direction of the balloon, so as to switch between the first position and the second position.

[0052] In order to further improve the compactness of the balloon structure and facilitate production and manufacturing, in an embodiment, referring to Figures 1 to 3 The guide member 20 can be a lumen tube penetrating through the balloon main body 10 and communicating with the inner cavity of the balloon main body 10.

[0053] In the embodiment, when the guide member 20 is a lumen tube, the inner cavity of the lumen tube is a guide wire cavity for inserting a guide wire. In this way, the original lumen tube distal end part of the balloon can be fully utilized as a sliding seat of the pressure-resistant sleeve 30.

[0054] It should be noted that in the embodiment, in the initial state, the balloon main body 10 is in a folded and contracted state, the fiber mesh is folded on the lumen tube, and the fiber mesh is located on the lumen tube at the distal end of the balloon main body 10. The proximal end of the fiber mesh is connected to the two traction lines, and the traction lines extend to the proximal end and reach outside the body. After the balloon main body 10 is delivered to the target position, the operator pulls the traction lines to pull the fiber mesh to the outside of the balloon main body 10 and wrap the balloon main body 10. When the resistance is obviously felt, the fiber mesh covers the entire balloon main body 10, and the balloon main body 10 is filled. Since the outside of the balloon main body 10 is restrained by the fiber mesh, the deformation amount of the balloon main body 10 is limited during the filling process, so that the balloon main body 10 can withstand higher pressure without rupture; the balloon main body 10 is expanded for the stenosis lesion, and then the balloon main body 10 is depressurized and contracted, and finally the balloon is withdrawn from the body.

[0055] In the embodiment, the part of the lumen tube located in the inner cavity of the balloon main body 10 can be provided with a developing part 201 for making the balloon visible under image detection light.

[0056] Preferably, the developing part 201 can be a plurality of developing rings. This facilitates the operator to know the position of the balloon main body 10 in the human body, and is beneficial to improve the convenience and safety of operation.

[0057] Of course, in some other embodiments, the guide member 20 can also adopt a columnar structure or a conical structure, etc. One end of the guide member 20 is connected with the distal end of the balloon main body 10, and the other end of the guide member 20 extends in the direction away from the axial direction of the balloon main body 10.

[0058] The present application sets the fiber net and the balloon body 10 separately during delivery, so that the overall outer diameter of the balloon body 10 is relatively small, the wall thickness is relatively thin, and the balloon body 10 has better passability in the blood vessel; the fiber net is sleeved on the outer periphery of the balloon body 10 when it is used, the fiber net binds the deformation of the balloon, so that the balloon body 10 can withstand higher pressure.

[0059] The present application also provides a balloon dilatation catheter, which comprises a balloon, and the specific structure of the balloon is referred to the above-mentioned embodiments. Since the balloon dilatation catheter provided by the present application comprises all the embodiments and all the schemes of the above-mentioned balloon, at least the same technical effects as the above-mentioned balloon are achieved, and here is not elaborated one by one.

[0060] Reference Figures 1 to 4 In an embodiment of the present application, the balloon dilatation catheter further comprises an outer catheter 50 and a catheter seat 60, the distal end of the outer catheter 50 is connected with the proximal end of the balloon, and the catheter seat 60 is fixed to the proximal end of the outer catheter 50.

[0061] In order to further make full use of the existing structure of the balloon catheter, improve the compactness of the structure of the balloon dilatation catheter, and reduce the manufacturing cost, in the embodiment, the outer catheter 50 can be sleeved on the outer periphery of the guide member 20 and form a plenum chamber with the guide member 20, the guide member 20 of the balloon is preferably an inner lumen tube with a guide wire lumen, the inner lumen tube penetrates through the balloon body 10, the catheter seat 60 is provided with a plenum opening 60a in communication with the plenum chamber and a guide wire opening 60b in communication with the proximal end of the guide member 20. The plenum opening 60a is used for the balloon body 10 to be inflated and expanded or to be deflated and contracted. The guide wire opening 60b is used for the guide wire to be led out.

[0062] In the embodiment, the catheter seat 60 can also be provided with an outlet for the controlled end of the traction line to be led out, so as to facilitate the operator to control the traction line.

[0063] In another embodiment, the catheter seat 60 can also be modified, and a motor and a rope winding disc are arranged in the catheter seat 60, the motor is drivingly connected with the rope winding disc, the controlled end of the traction line can be wound on the rope winding disc, and the traction line is driven to move by the motor driving the rope winding disc to rotate, so as to drive the pressure-resistant sleeve 30 to switch between the first position and the second position.

[0064] In addition, in other embodiments, an additional control handle can also be provided, the control handle is provided with a motor and a rope winding disc, and the proximal end of the traction line is led into the control handle and wound on the rope winding disc in the control handle.

[0065] The above-mentioned is only the optional embodiment of the present application, and does not limit the patent range of the present application, and any equivalent structural transformation made according to the content of the present application specification and drawings, or direct / indirect application in other related technical fields within the concept of the present application is included in the patent protection range of the present application.

Claims

1. A balloon characterized in that, The balloon catheter comprises: a balloon body; a guide member arranged at the distal end of the balloon body; a pressure-resistant sleeve movably switched between a first position and a second position, in the first position, the pressure-resistant sleeve is sleeved on the outer periphery of the guide member, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the guide member and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body, in the second position, the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body, or most of the pressure-resistant sleeve is sleeved on the outer periphery of the balloon body and a small part of the pressure-resistant sleeve is sleeved on the outer periphery of the guide member, the pressure-resistant sleeve is a fiber mesh, and the material of the fiber mesh is one or more of high-strength fibers composed of poly-p-phenylene terephthalamide fibers, aromatic polyamide copolymer fibers, heterocyclic polyamide fibers, carbon fibers, graphite fibers, and silicon carbide fibers; and a control member connected with the pressure-resistant sleeve, the control member being used to control the pressure-resistant sleeve to switch between the first position and the second position. The pressure-resistant sleeve is used to be pulled to the outer periphery of the balloon body under the driving of the control member after the balloon is delivered to a target position, so as to wrap on the balloon body and limit the deformation amount of the balloon body in the inflation process.

2. The balloon of claim 1, wherein, The control member is a traction wire, a line, a rope, or a rod.

3. The balloon of claim 2, wherein, The control member has two, one end of each of the two control members is connected to the proximal end of the pressure-resistant sleeve, and the connection points of the two control members are located on the two ends of the diameter of the pressure-resistant sleeve, the other end of the control member is a controlled end and is adapted to be located outside the body.

4. The balloon of claim 1, wherein, The balloon body is made of a high polymer material, and the high polymer material includes at least one of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, and polyethylene terephthalate.

5. The balloon of claim 1, wherein, The guide member is a solid column or a hollow tube, one end of the guide member is connected to the distal end of the balloon body, and the other end of the guide member extends in a direction away from the balloon body in an axial direction. Alternatively The guide member is a lumen tube arranged through the balloon body and communicating with the inner cavity of the balloon body.

6. The balloon of claim 5, wherein, When the guide member is the lumen tube, the inner cavity of the lumen tube is a guide wire cavity for inserting a guide wire.

7. The balloon of claim 6, wherein, The part of the lumen tube located on the inner cavity of the balloon body is provided with a developing part, and the developing part is used to make the balloon visible under image detection light.

8. A balloon dilatation catheter characterized by, The balloon catheter comprises: the balloon according to any one of claims 1-7; an outer catheter, a distal end of the outer catheter being connected to a proximal end of the balloon; and a catheter seat fixed to a proximal end of the outer catheter. The outer catheter is sleeved on the outer periphery of the guide member and surrounds the guide member to form an inflation cavity, the guide member of the balloon is a lumen tube having a guide wire cavity, and the catheter seat is provided with an inflation port communicating with the inflation cavity and a guide wire port communicating with the proximal end of the guide member.

9. The balloon dilation catheter of claim 8, wherein, ​

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