Balloon and balloon dilatation catheter

Abstract

The invention discloses a balloon and a balloon dilatation catheter, and relates to the technical field of medical instruments. The balloon comprises a balloon main body, a guide piece, a pressure-resistant sleeve and a control piece, the guide piece is arranged at the far end of the balloon main body; the pressure-resistant sleeve is sleeved on the guide piece between a first position and a second position in a movable switching manner; at the first position, the pressure-resistant sleeve is sleeved on the periphery of the guide piece; at the second position, the pressure-resistant sleeve is sleeved on the periphery of the balloon main body; the control piece is connected with the pressure-resistant sleeve and used for controlling the pressure-resistant sleeve to be switched between the first position and the second position. The structure of the balloon is improved, the thickness of the balloon is reduced, the balloon is easier to fold and wind, the trafficability of the balloon in a blood vessel is improved, and the operation difficulty is reduced; meanwhile, the balloon can bear high pressure.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a balloon and a balloon dilation catheter. Background Technology

[0002] Balloon dilation catheters are among the most widely used medical devices in interventional vascular therapy, used to treat symptoms of vascular stenosis or occlusion. The principle involves inserting a balloon catheter into the narrowed area of ​​the blood vessel via percutaneous puncture, and then dilating the balloon under the guidance of medical imaging equipment, thereby expanding the narrowed area and restoring the blood vessel to its normal lumen diameter. Compared with surgery, balloon dilation technology has advantages such as simple operation, minimal trauma, fewer complications, repeatability, rapid postoperative recovery, and high safety and reliability.

[0003] The rated burst pressure of existing balloons is typically between 8 and 24 atm. However, for lesions with severe calcification, heavy plaque burden, or long-term chronic occlusion, a higher rated burst pressure (greater than 24 atm) is often required to dilate the lesion. To improve the pressure resistance of balloons, a common method is to weave fibers onto the outer surface of the balloon using a braiding machine and then apply a thick layer of adhesive to fix the fiber mesh to the balloon. This method not only increases the thickness of the balloon but also increases its overall rigidity and volume, affecting the folding and winding process and reducing its permeability within the blood vessel, thus increasing the difficulty of the surgical procedure. Summary of the Invention

[0004] The main objective of this invention is to provide a balloon and balloon dilation catheter that reduces the thickness of the balloon, improves the folding and winding ability of the balloon, enhances the balloon's passage within blood vessels, reduces the difficulty of the procedure, and allows the balloon to withstand higher pressures.

[0005] To achieve the above objectives, the present invention provides a balloon comprising: The main body of the balloon; A guide element is located at the distal end of the balloon body; A pressure-resistant sleeve is movably fitted onto the guide member between a first position and a second position; in the first position, the pressure-resistant sleeve is fitted around the outer periphery of the guide member, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the guide member and a small portion fitted around the outer periphery of the balloon body; in the second position, the pressure-resistant sleeve is fitted around the outer periphery of the balloon body, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the balloon body and a small portion fitted around the outer periphery of the guide member; and 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.

[0006] 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.

[0007] Optionally, the control element is a traction wire, line, rope, or rod.

[0008] 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.

[0009] 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.

[0010] 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 The guide is an inner tube that penetrates the balloon body and communicates with the inner cavity of the balloon body.

[0011] Optionally, when the guide is the inner tube, the inner cavity of the inner tube is a guide wire cavity for guide wire insertion.

[0012] 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.

[0013] To achieve the above objectives, the present invention also provides a balloon dilation catheter, comprising: The balloon as described above; An external catheter, the distal end of which is connected to the proximal end of the balloon; and A catheter hub is fixed to the proximal end of the external catheter; The balloon includes: The main body of the balloon; A guide element is located at the distal end of the balloon body; A pressure-resistant sleeve is movably fitted onto the guide member between a first position and a second position; in the first position, the pressure-resistant sleeve is fitted around the outer periphery of the guide member, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the guide member and a small portion fitted around the outer periphery of the balloon body; in the second position, the pressure-resistant sleeve is fitted around the outer periphery of the balloon body, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the balloon body and a small portion fitted around the outer periphery of the guide member; and 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.

[0014] Optionally, the external catheter is sleeved around the periphery of the guide and surrounds it to form an inflation cavity. The guide of the balloon is an inner tube with a guidewire cavity. The catheter seat is provided with an inflation port communicating with the inflation cavity and a guidewire port communicating with the proximal end of the guide.

[0015] In the technical solution of this invention, the balloon includes a balloon body, a guide, a pressure-resistant sleeve, and a control component. The guide is located 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 fitted around the outer periphery of the guide, or most of the pressure-resistant sleeve is fitted around the outer periphery of the guide, with a small portion fitted around the outer periphery of the balloon body. In the second position, the pressure-resistant sleeve is fitted around the outer periphery of the balloon body, with most of the pressure-resistant sleeve fitted around the outer periphery of the balloon body and a small portion fitted around the outer periphery of the guide. The control component is connected to the pressure-resistant sleeve and is used to control the switching of the pressure-resistant sleeve between the first and second positions. In the initial state, the balloon body is in a folded and contracted state, the pressure-resistant sleeve is folded onto the guide at the distal end of the balloon body, and the proximal end of the pressure-resistant sleeve is connected to the control component, which extends proximally outward for manipulation by the operator. After the balloon is delivered to the target location, the operator controls the manipulator to pull the pressure-resistant sleeve all the way to the outer periphery of the balloon body, wrapping it around the balloon body. When the operator clearly feels resistance, the pressure-resistant sleeve exactly covers the entire balloon body. Then, the balloon body is inflated. Because the outer side of the balloon body is restrained by the pressure-resistant sleeve, the deformation of the balloon body during inflation is limited, allowing the balloon body to withstand higher pressure without rupture. After the balloon body is inflated, the stenotic lesion is dilated, and then the balloon body is depressurized and contracted. Finally, the entire balloon is withdrawn from the body. It can be understood that this invention improves the balloon structure, reduces the overall thickness of the balloon during delivery, improves the balloon's permeability within blood vessels, and makes the balloon easier to fold and roll, reducing the difficulty of the procedure; at the same time, it ensures that the balloon body can withstand higher pressure. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of the balloon of the present invention when the pressure-resistant sleeve is in the first position in one embodiment; Figure 2 This is a schematic diagram of the structure of the balloon of the present invention when the pressure-resistant sleeve is in the second position; Figure 3 This is a schematic diagram of the structure of the balloon in one embodiment of the present invention, with the pressure-resistant sleeve in the second position and the balloon body inflated; Figure 4 This is a schematic diagram of the structure of the balloon dilation catheter of the present invention when the pressure sleeve is in the second position.

[0018] Explanation of icon numbers: 10. Balloon body; 20. Guide component; 30. Pressure-resistant sleeve; 40. Control component; 201. Imaging section; 50. External catheter; 60. Catheter seat; 60a. Inflation port; 60b. Guidewire port.

[0019] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0021] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0022] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0023] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. The word "and / or" throughout the text means including three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. The technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0024] This invention proposes a high-pressure thin-walled membrane balloon.

[0025] Reference Figures 1 to 3 In one embodiment of the present invention, the balloon includes a balloon body 10, a guide 20, a pressure-resistant sleeve 30, and a control member 40; the guide 20 is disposed 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; in the first position, the pressure-resistant sleeve 30 is entirely fitted around the outer periphery of the guide 20, or most of the pressure-resistant sleeve 30 is fitted around the outer periphery of the guide 20, and a small portion is fitted around the outer periphery of the balloon body 10; in the second position, the pressure-resistant sleeve 30 is entirely fitted around the outer periphery of the balloon body 10, or most of the pressure-resistant sleeve 30 is fitted around the outer periphery of the balloon body 10, and a small portion is fitted around the outer periphery of the guide 20; the control member 40 is connected to the pressure-resistant sleeve 30, and the control member 40 is used to control the pressure-resistant sleeve 30 to switch between the first position and the second position.

[0026] In this embodiment, the balloon body 10 is made of a polymer material, which includes at least one of the following materials: polyvinyl chloride (PVC), polyethylene (PE), polyurethane (TPU), polyamide (Nylon), polyether block polyamide (Pebax), and polyethylene terephthalate (PET), etc., and is not limited here.

[0027] The guide member 20 can be a solid column or a hollow tube, etc., which can allow the pressure sleeve 30 to slide. There is no limitation here.

[0028] The pressure-resistant sleeve 30 can be a hollow fiber mesh or a non-hollow sleeve structure. The pressure-resistant sleeve 30 has a certain elasticity and can expand with the expansion of the balloon body 10 and has a strong pressure resistance. Its structure and material are not limited here.

[0029] The control element 40 can be a traction wire, line, rope, or rod, etc., and is not limited here. The control element 40 can be designed as a structure that is manually pulled to operate, or it can be designed as a structure that is automatically controlled by being driven by a motor or the like, and is not limited here.

[0030] In the initial state, the balloon body 10 is in a folded and contracted state, with the pressure-resistant sleeve 30 folded onto the guide 20 at the distal end of the balloon body 10. The proximal end of the pressure-resistant sleeve 30 is connected to the control element 40, which extends proximally outward for the operator to manipulate. After the balloon is delivered to the target location, the operator can control the proximal end of the control element 40 to pull the pressure-resistant sleeve 30 all the way to the outer periphery of the balloon body 10, wrapping it around the balloon body 10. When the operator clearly feels resistance, the pressure-resistant sleeve 30 just covers the entire balloon body 10. Then, the balloon body 10 is inflated. Because the outer side of the balloon body 10 is restrained by the pressure-resistant sleeve 30, the deformation of the balloon body 10 during inflation is limited, allowing the balloon body 10 to withstand higher pressure without rupture. After the balloon body 10 is inflated, the stenotic lesion is dilated, and then the balloon body 10 is depressurized and contracted. Finally, the entire balloon is withdrawn from the body.

[0031] It is understood that the present invention improves the structure of the balloon, reduces the overall thickness of the balloon during delivery, improves the balloon's permeability in blood vessels, and makes the balloon easier to fold and roll, reducing the difficulty of the procedure; at the same time, it ensures that the balloon body 10 can withstand high pressure.

[0032] To reduce the volume of the pressure-resistant sleeve 30 and improve its deformability and pressure resistance, in one embodiment, referring to... Figures 1 to 3 The pressure-resistant sleeve 30 can be a fiber web, and the fiber web can be 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, silicon carbide fiber, etc.

[0033] In one embodiment, reference is made to Figures 1 to 3 The control element 40 can preferably consist of two traction lines, one end of which is connected to the proximal end of the pressure-resistant sleeve 30, with the connection point located at both ends of the diameter of the pressure-resistant sleeve 30. The other end of the two traction lines is the controlled end and is suitable for placement outside the body. This simplifies the structure of the balloon as much as possible and helps reduce product costs.

[0034] In this embodiment, the controlled ends of the two traction lines can be free ends, allowing the operator to directly control them. Alternatively, the two traction lines can be connected to a motor or other driving component, with the motor automatically controlling the winding or unwinding of the traction lines, thereby driving the pressure sleeve 30 to move axially along the balloon, switching between the first and second positions.

[0035] To further improve the structural compactness of the balloon and facilitate manufacturing, in one embodiment, reference is made to... Figures 1 to 3 The guide 20 can be an inner tube that penetrates the balloon body 10 and communicates with the inner cavity of the balloon body 10.

[0036] In this embodiment, when the guide 20 is an inner tube, the inner cavity of the inner tube is a guide wire cavity for guide wire insertion. This arrangement can make full use of the distal part of the original inner tube of the balloon as a slide for the pressure-resistant sleeve 30.

[0037] It should be noted that in this embodiment, initially, the balloon body 10 is in a folded and contracted state, with the fiber mesh folded onto the inner lumen tube at the distal end of the balloon body 10. Two traction lines are connected to the proximal end of the fiber mesh, extending proximally to the outside of the body. After the balloon body 10 is delivered to the target location, the operator pulls the traction lines, pulling the fiber mesh all the way to the outside of the balloon body 10, covering it. When significant resistance is felt, the fiber mesh precisely covers the entire balloon body 10, inflating it. Because the outside of the balloon body 10 is restrained by the fiber mesh, the deformation of the balloon body 10 during inflation is limited, allowing it to withstand higher pressure without rupture. After inflation, the balloon body 10 expands the stenotic lesion, then the balloon body 10 is depressurized and contracted, finally withdrawing the entire balloon from the body.

[0038] In this embodiment, a developing section 201 may be provided on the portion of the inner tube located within the inner cavity of the balloon body 10. The developing section 201 is used to make the balloon visible under image detection light.

[0039] Preferably, the imaging section 201 can consist of several imaging rings. This allows the operator to easily identify the position of the balloon body 10 within the body, improving both the convenience and safety of the procedure.

[0040] Of course, in some other embodiments, the guide member 20 may also adopt a columnar structure or a conical structure, with one end of the guide member 20 connected to the distal end of the balloon body 10, and the other end of the guide member 20 extending in a direction away from the axial direction of the balloon body 10.

[0041] The present invention separates the fiber mesh and the balloon body 10 during delivery, so that the overall outer diameter of the balloon body 10 is relatively small and the wall thickness is relatively thin, and the balloon body 10 has better passage in blood vessels; when it is to be used, the fiber mesh is then wrapped around the outer periphery of the balloon body 10, and the fiber mesh restrains the deformation of the balloon, so that the balloon body 10 can withstand higher pressure.

[0042] The present invention also proposes a balloon dilation catheter, which includes a balloon. The specific structure of the balloon is as described in the above embodiments. Since the balloon dilation catheter proposed in this invention includes all the solutions of all the above-described balloon embodiments, it has at least the same technical effects as the above-described balloon, which will not be described in detail here.

[0043] Reference Figures 1 to 4 In one embodiment of the present invention, the balloon dilation catheter further includes an outer catheter 50 and a catheter seat 60, the distal end of the outer catheter 50 being connected to the proximal end of the balloon, and the catheter seat 60 being fixed to the proximal end of the outer catheter 50.

[0044] To further utilize the existing structure of the balloon catheter, improve its structural compactness, and reduce manufacturing costs, in this embodiment, the outer catheter 50 can be sleeved around the periphery of the guide member 20 and form an inflation cavity with it. The guide member 20 of the balloon is preferably an inner tube with a guidewire cavity, which penetrates the balloon body 10. The catheter seat 60 is provided with an inflation port 60a communicating with the inflation cavity and a guidewire port 60b communicating with the proximal end of the guide member 20. The inflation port 60a is used for inflation or deflation of the balloon body 10. The guidewire port 60b is used for guidewire extraction.

[0045] In this embodiment, the catheter hub 60 may also be provided with an outlet for the controlled end of the traction line to facilitate the operator's control of the traction line.

[0046] In another embodiment, the guide tube seat 60 can be modified by installing a motor and a rope reel inside the guide tube seat 60. The motor and the rope reel are connected for driving. The controlled end of the traction line can be wound on the rope reel. The motor drives the reel to rotate, thereby driving the traction line to move, which in turn drives the pressure-resistant sleeve 30 to switch between the first position and the second position.

[0047] In addition, in other embodiments, a control handle may be provided, which contains a motor and a rope reel. The proximal end of the traction line is led into the control handle and wound around the rope reel inside the control handle.

[0048] The above description is merely an optional embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A balloon, characterized in that, include: The main body of the balloon; A guide element is located at the distal end of the balloon body; A pressure-resistant sleeve is movably fitted onto the guide member between a first position and a second position. In the first position, the pressure-resistant sleeve is fitted around the outer periphery of the guide member, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the guide member and a small portion is fitted around the outer periphery of the balloon body. In the second position, the pressure-resistant sleeve is fitted around the outer periphery of the balloon body, or the pressure-resistant sleeve is mostly fitted around the outer periphery of the balloon body and a small portion is fitted around the outer periphery of the guide member. as well as 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.

2. The balloon as described in claim 1, characterized in that, 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.

3. The balloon as described in claim 1, characterized in that, The control element is a traction wire, line, rope, or rod.

4. The balloon as described in claim 3, characterized in that, The control element has two components, one end of each component is connected to the proximal end of the pressure-resistant sleeve, and the connection point of the two components is located at both ends of the diameter of the pressure-resistant sleeve. The other end of each control element is a controlled end and is adapted to be located outside the body.

5. The balloon as claimed in claim 1, characterized in that, The main body of the balloon is made of a polymer material, which includes at least one of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, and polyethylene terephthalate.

6. The balloon as claimed in claim 1, characterized in that, The guide is a solid column or a hollow tube; one end of the guide is connected to the distal end of the balloon body, and the other end of the guide extends in a direction away from the axial direction of the balloon body. or The guide is an inner tube that penetrates the balloon body and communicates with the inner cavity of the balloon body.

7. The balloon as described in claim 6, characterized in that, When the guide is the inner tube, the inner cavity of the inner tube is a guide wire cavity for guide wire insertion.

8. The balloon as claimed in claim 7, characterized in that, 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.

9. A balloon dilation catheter, characterized in that, include: The balloon as described in any one of claims 1-8; An external catheter, the distal end of which is connected to the proximal end of the balloon; as well as The catheter hub is fixed to the proximal end of the external catheter.

10. The balloon dilation catheter as described in claim 9, characterized in that, The external catheter is sleeved around the outer periphery of the guide member and forms an inflation cavity with it. The guide member of the balloon is an inner tube with a guidewire cavity. The catheter seat is provided with an inflation port communicating with the inflation cavity and a guidewire port communicating with the proximal end of the guide member.

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