Balloon and umbrella integrated device with hollow structure

Abstract

This invention provides a hollow balloon and protective umbrella integrated device, belonging to the field of medical device technology. The device includes a delivery tube, a cylindrical balloon, and a protective umbrella. The cylindrical balloon is located at the distal end of the delivery tube and has a coaxially arranged hollow cavity at both ends for blood flow. The sidewall of the cylindrical balloon has a receiving chamber for holding the filling medium. The protective umbrella is integrated at a predetermined distance from the distal end of the cylindrical balloon to intercept emboli that may fall during balloon support. During operation, the cylindrical balloon and protective umbrella are delivered synchronously with the delivery tube to reduce operational steps. This invention primarily addresses the technical problems in existing technologies, such as interrupted blood flow during balloon expansion, cumbersome operational steps leading to low surgical efficiency, and high risks associated with multiple instrument operations.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a hollow balloon and protective umbrella integrated device. Background Technology

[0002] Vascular stenosis refers to a pathological condition in which the effective passage of blood vessels narrows due to various factors, obstructing blood flow. It is most commonly seen in atherosclerosis—lipids (such as cholesterol) in the blood deposit on the inner wall of blood vessels, forming "atherosclerotic plaques." As these plaques enlarge, they gradually encroach on the lumen, leading to reduced blood flow. Downstream tissues at the site of stenosis experience functional abnormalities due to insufficient blood supply, such as angina pectoris caused by coronary artery stenosis, dizziness caused by cerebral artery stenosis, and intermittent claudication caused by lower limb artery stenosis.

[0003] Currently, treatments for vascular stenosis include medication, surgery, and endovascular interventional therapy. Among these, endovascular interventional therapy has become an important clinical treatment for vascular stenosis due to its advantages such as minimal invasiveness and rapid recovery. This treatment method achieves thrombus removal and vascular patency through various surgical techniques, including stent placement, endovascular aspiration, and plaque excision. In stent placement, the standard operating procedure is as follows: First, the narrowed area of ​​the blood vessel is dilated using a balloon to increase the lumen space, creating conditions for subsequent stent implantation. The stent is usually pre-placed on the outside of the balloon. When the balloon inflates at the narrowed area, it simultaneously pushes the stent to the narrowed area and ensures it adheres tightly to the vessel wall, providing long-term support and maintaining vascular patency. However, during this treatment, the narrowed tissue (small emboli) in the narrowed area may break off from its original location and escape to the distal end along the blood flow. The escape of the emboli can cause embolism in other blood vessels, resulting in adverse consequences. Therefore, before placing the balloon, it is necessary to first place an embolization umbrella at the distal end of the narrowed area. The umbrella is supported in the blood vessel to intercept the drifting small emboli.

[0004] Most existing balloons used clinically are closed structures. When the balloon inflates at a narrow point in a blood vessel to achieve dilation, the closed structure inevitably completely blocks the vessel lumen, causing a temporary interruption of blood flow at that location. This temporary interruption of blood flow may disrupt the normal hemodynamic environment within the vessel, increasing the risk of thrombosis and negatively impacting the treatment outcome. Furthermore, because the existing balloon and embolization umbrella are relatively independent instruments, the entire surgical procedure requires a series of sequential operations, including the delivery, positioning, and deployment of the embolization umbrella, as well as the delivery, dilation, and stent deployment of the balloon and stent. Each step requires precise control of the instrument's position and status within the blood vessel. This multi-step instrument entry and exit procedure significantly increases the difficulty of the surgery and substantially prolongs the operation time.

[0005] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0006] The purpose of this invention is to provide a hollow balloon and protective umbrella integrated device to solve the technical problems of interruption of blood flow during balloon expansion, cumbersome operation steps leading to low surgical efficiency, and high risk of multiple instrument operation in the prior art.

[0007] To achieve the above objectives, the hollow-structured integrated balloon and protective umbrella device of the present invention provides the following technical solution:

[0008] A hollow-structured balloon-and-protective umbrella integrated device includes:

[0009] Push tube;

[0010] A tubular balloon is disposed at the distal end of the push tube. The tubular balloon has a hollow cavity coaxially arranged at both ends for blood flow to pass through. The side wall of the tubular balloon has a receiving chamber for holding the filling medium.

[0011] A protective umbrella is integrally installed at the far end of the tubular balloon at a set distance from it, and is used to intercept emboli that fall during the support of the tubular balloon.

[0012] During operation, the tubular balloon and protective umbrella are delivered synchronously along with the delivery tube to reduce operational steps.

[0013] As a further optimized technical solution, the tubular balloon is provided with a support frame for radial expansion. The support frame penetrates the tubular balloon and extends to the distal end. The protective umbrella is located at the distal end of the support frame. The radial expansion of the support frame is used to support the deployment of the protective umbrella to intercept the embolus.

[0014] As a further optimized technical solution, the support frame includes multiple support rods, which are arranged at intervals along the circumference of the tubular balloon, with the proximal end connected to the push tube and the distal end connected to the protective umbrella.

[0015] As a further optimized technical solution, the support rod has an axially extending cavity inside, which is fixedly connected to the receiving chamber and is used to deliver a filling medium into the receiving chamber.

[0016] As a further optimized technical solution, each of the support rods passes through the receiving chamber, and the portion of the support rod passing through the receiving chamber is in communication with the receiving chamber.

[0017] As a further optimized technical solution, the support frame at the proximal end of the protective umbrella protrudes radially outward to fully support the protective umbrella to fit snugly against the blood vessel wall.

[0018] As a further optimized technical solution, the tubular balloon includes an elastic bladder and a shape control component for controlling the regular contraction of the elastic bladder.

[0019] As a further optimized technical solution, the shape control component is a nickel-titanium alloy wire disposed inside the elastic capsule, and the nickel-titanium alloy wire is arranged at least along the circumference of the elastic capsule.

[0020] As a further optimized technical solution, the protective umbrella is a membrane structure with filter holes arranged on it.

[0021] As a further optimized technical solution, the protective umbrella 5 has a mesh woven structure, and the mesh size of the woven holes on the woven structure gradually decreases from the near end to the far end.

[0022] Beneficial effects: The tubular balloon of this invention has a hollow cavity extending through both ends in the middle. Even when the balloon is inflated, blood flow can still pass through the hollow cavity normally, avoiding the blood flow interruption problem caused by traditional closed balloons. This maintains the normal hemodynamic environment within the blood vessel, reduces the risk of thrombosis, and improves treatment safety. In addition, this invention integrates the tubular balloon and the protective umbrella into the same device, and achieves delivery, positioning, and release simultaneously through the push tube. There is no need to operate two instruments separately, reducing surgical steps, shortening surgical time, reducing the difficulty of operation for doctors, and reducing the number of times instruments enter and exit the blood vessel, thus reducing the risk of damage to the inner wall of the blood vessel.

[0023] Furthermore, the design of the support rod and shape control components ensures that the tubular balloon expands evenly and contracts regularly, providing stable support and avoiding intraoperative structural failure.

[0024] Furthermore, the design of the support frame at the proximal end of the protective umbrella protruding radially outward allows the protective umbrella to fit more tightly against the blood vessel wall, effectively intercepting emboli. At the same time, the membrane or mesh structure of the protective umbrella ensures blood flow while intercepting emboli, thus improving the treatment effect. Attached Figure Description

[0025] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein:

[0026] Figure 1 This is a schematic diagram of the overall structure of Embodiment 1 of the hollow-structured integrated balloon and protective umbrella device of the present invention;

[0027] Figure 2 This is a schematic diagram of one end of an embodiment 1 of the hollow structure balloon and protective umbrella integrated device of the present invention;

[0028] Figure 3 This is a schematic diagram of another end of Embodiment 1 of the hollow structure balloon and protective umbrella integrated device of the present invention;

[0029] Figure 4 This is a schematic cross-sectional view of the cylindrical balloon in Embodiment 1 of the hollow balloon and protective umbrella integrated device of the present invention;

[0030] Figure 5 This is a cross-sectional schematic diagram of Embodiment 1 of the hollow structure balloon and protective umbrella integrated device of the present invention;

[0031] Figure 6 This is a schematic diagram of the overall structure of Embodiment 2 of the hollow-structured balloon and protective umbrella integrated device of the present invention;

[0032] Figure 7 This is a schematic diagram of the end of Embodiment 2 of the hollow structure balloon and protective umbrella integrated device of the present invention.

[0033] In the diagram: 1. Push tube; 2. Tubular balloon; 21. Elastic bladder; 22. Shape control component; 3. Hollow cavity; 4. Receiving chamber; 5. Protective umbrella; 6. Support rod; 61. Protrusion; 7. Filter hole. Detailed Implementation

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0035] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances. Furthermore, the term "proximal end" uniformly refers to the end closer to the operator, while "distal end" refers to the end farther from the operator.

[0036] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0037] The shapes and sizes of the components in the accompanying drawings do not reflect the actual proportions of the product; they are only intended to illustrate the content of the invention.

[0038] This invention provides a hollow balloon and protective umbrella integrated device, mainly used to solve the technical problems of blood flow interruption, low embolus interception efficiency, and cumbersome instrument operation during traditional vascular interventional treatment. The device includes a push tube 1, a cylindrical balloon 2, and a protective umbrella 5. The cylindrical balloon 2 is located at the distal end of the push tube 1, with a through hollow cavity 3 in the middle to ensure blood flow, and a receiving chamber 4 inside the side wall to accommodate the filling medium. The protective umbrella 5 is integrally disposed at the distal end of the cylindrical balloon 2. A support frame is provided on the cylindrical balloon 2, and the support frame includes support rods 6 spaced circumferentially along the cylindrical balloon 2. The lumen of the support rods 6 communicates with the receiving chamber 4 to deliver the filling medium. The support rods 6 unfold as the cylindrical balloon 2 expands, thereby allowing the protective umbrella 5 to conform to the blood vessel wall to intercept emboli. Through the above technical solution, this invention can reduce surgical operation steps, shorten operation time, reduce instrument placement procedures, and improve surgical safety. Detailed technical solutions are provided in the embodiments below.

[0039] Example 1

[0040] like Figure 1 , Figure 2 , Figure 3 As shown, the hollow-structured integrated balloon and protective umbrella device includes a push tube 1, a cylindrical balloon 2, and a protective umbrella 5.

[0041] The push tube 1 is made of medical materials and has a main channel inside for conveying filling medium.

[0042] like Figure 5 As shown, the tubular balloon 2 is positioned at the distal end of the delivery tube 1 and is made of medical-grade soft elastic material. The tubular balloon 2 has a coaxially arranged hollow cavity 3 extending through both ends for blood flow. The inner sidewall of the tubular balloon 2 has a receiving chamber 4 for holding the filling medium. The receiving chamber 4 surrounds the hollow cavity 3, forming a ring structure. When the filling medium is filled into the receiving chamber 4, the tubular balloon 2 expands into a hollow cylindrical shape. While the outer wall supports the narrowed area within the blood vessel, the internal hollow cavity 3 ensures unobstructed blood flow, improving surgical safety. The filling medium is withdrawn from the receiving chamber 4, allowing the tubular balloon 2 to contract and reposition, facilitating its removal from the body after surgery.

[0043] The protective umbrella 5 is integrally positioned at a predetermined distance from the distal end of the tubular balloon 2. The specific predetermined distance is determined based on the distance between the narrowed portion of the blood vessel and the distal normal blood vessel. Generally, it is sufficient to ensure a suitable distance between the distal end of the tubular balloon 2 and the proximal end of the protective umbrella 5. Alternatively, the distance between the separate balloon and the protective umbrella 5 in existing technologies can be referenced. The protective umbrella 5 is used to intercept emboli that fall during the support of the tubular balloon 2. In this embodiment, the protective umbrella 5 is a membrane structure made of ultra-thin medical-grade polyimide or polyester material. The membrane structure has filter pores 7 arranged on it. The pore size of the filter pores 7 gradually decreases from 250μm to 50μm from the proximal end to the distal end, effectively intercepting and filtering small thrombus fragments. This allows for complete capture of detached thrombus fragments while allowing normal blood flow, avoiding interference with distal blood flow.

[0044] During operation, the tubular balloon 2 and the protective umbrella 5 are delivered, positioned and released synchronously with the push tube 1, eliminating the need to operate the two instruments separately and effectively reducing surgical procedures.

[0045] Furthermore, to achieve stable deployment and support of the protective umbrella 5, a support frame for radial expansion is provided on the tubular balloon 2. The support frame penetrates the tubular balloon 2 and extends distally, with the protective umbrella 5 fixedly positioned at the distal end of the support frame. When the tubular balloon 2 inflates, the support frame expands radially synchronously with the tubular balloon 2, thereby driving the protective umbrella 5 to deploy, ensuring that the protective umbrella 5, at least at its proximal opening, adheres to the inner wall of the blood vessel, ensuring sufficient interception of emboli. In this embodiment, the support frame includes multiple support rods 6, which are evenly spaced along the circumference of the tubular balloon 2. Typically, 4-10 support rods 6 are provided to ensure balanced support force. The proximal ends of all support rods 6 are axially converged and fixedly connected to the push tube 1, and the distal ends are also axially converged and fixedly connected to the protective umbrella 5. The protective umbrella 5 is fitted and fixedly connected to the outside of all support rods 6 using medical adhesive to ensure connection strength and prevent intraoperative detachment.

[0046] Furthermore, the support rod 6 has an axially extending lumen inside, which is fixedly connected to the receiving chamber 4 for conveying filling medium into the receiving chamber 4. The filling medium can be physiological saline, contrast agent, or gas. It is connected to the lumen of the support rod 6 through the main channel inside the push tube 1 to realize the operation of filling and releasing the filling medium in the receiving chamber 4.

[0047] To further optimize the delivery path of the filling medium, each support rod 6 passes through the receiving chamber 4. The part of the support rod 6 that passes through the receiving chamber 4 has a connecting hole, so that the lumen of the support rod 6 is directly connected to the receiving chamber 4. This design can ensure that the filling medium fills the entire receiving chamber 4 quickly and evenly, avoiding the problem of poor expansion effect caused by uneven local expansion of the tubular balloon 2.

[0048] Because traditional balloons rely solely on the elastic contraction of the balloon itself, retrieval is easily hindered after depressurization due to balloon material fatigue and localized wrinkles. This necessitates repeated adjustments to the retrieval force of the push tube 1, which not only prolongs the surgical time but may also damage the blood vessel wall. In this embodiment, as... Figure 4 As shown, to ensure the contraction and repositioning performance of the tubular balloon 2, the tubular balloon 2 includes an elastic capsule 21 and a shape control component 22 for controlling the regular contraction of the elastic capsule 21. The elastic capsule 21 is made of medical polyurethane or silicone material, which has good elasticity and biocompatibility. The shape control component 22 is a nickel-titanium alloy wire disposed inside the elastic capsule 21. The nickel-titanium alloy wire is arranged at least along the circumference of the elastic capsule 21 and can be arranged in a spiral or ring manner. When the receiving chamber 4 is depressurized, the nickel-titanium alloy wire can drive the elastic capsule 21 to contract rapidly to its initial shape, so that the elastic capsule 21 can be regularly folded and contracted into a three-layer small-diameter ring structure, which is convenient for instrument retrieval and avoids the retrieval difficulties caused by the wrinkles of the elastic capsule 21.

[0049] Furthermore, traditional balloon dilation is prone to "eccentric dilation" due to uneven balloon material and pressure distribution differences. This means that after balloon dilation, the balloon axis deviates from the blood vessel axis, resulting in insufficient dilation of the narrowed area and requiring secondary dilation. In this embodiment, the elastic balloon 21 uses a medical material with excellent uniform expansion characteristics (such as polyurethane with an elongation at break ≥600%, or silicone). Combined with the circumferential constraint of the shape control component 22, this ensures more uniform radial expansion of the elastic balloon 21 during dilation, and its shape is controllable, achieving precise dilation of the narrowed area. This reduces the need for secondary dilation operations and lowers the risk of excessive damage to the vascular intima.

[0050] In practical use, firstly, the tubular balloon 2, contracted to its initial state, and the protective umbrella 5 are inserted into the delivery sheath. The delivery sheath is then advanced to the target location (near the stenotic site) via vascular puncture. Next, the tubular balloon 2 is pushed distally to the stenotic site by pushing the push tube 1, ensuring the balloon 2's length fully covers the stenotic area. The protective umbrella 5 is positioned distal to the stenotic site. Normal saline is injected into the lumen of the support rod 6 through the main channel of the push tube 1. The filling medium enters the receiving chamber 4 through the connecting hole, causing the tubular balloon 2 to inflate and expand the stenotic site. Simultaneously, the support frame deploys the protective umbrella 5. During the process of supporting the stenotic site, any falling emboli are intercepted by the protective umbrella 5. After treatment, the filling medium in the receiving chamber 4 is withdrawn. The tubular balloon 2 contracts under the action of the shape control component 22, and the protective umbrella 5 contracts with the support frame. The push tube 1 is then pulled back into the delivery sheath, and the sheath is removed, completing the procedure.

[0051] Example 2

[0052] like Figure 6 , Figure 7As shown, the difference between this embodiment and embodiment 1 lies in the structure of the protective umbrella 5 and the shape of the support rod 6; the rest of the structure and usage process are basically the same.

[0053] In this embodiment, the support frame at the proximal end of the protective umbrella 5 protrudes radially outward by 61. The height of the protrusion 61 is determined according to the inner diameter of the blood vessel. The protrusion 61 can make the proximal edge of the protective umbrella 5 fit tightly against the blood vessel wall, preventing the embolus from escaping from the gap between the protective umbrella 5 and the blood vessel wall, and improving the reliability of interception.

[0054] Furthermore, in this embodiment, the protective umbrella 5 is a mesh woven structure made of medical nickel-titanium alloy wire; the size of the woven holes gradually decreases from 250μm to 50μm from the proximal end to the distal end. This gradual design can improve the interception efficiency of emboli of different sizes, while reducing resistance to blood flow.

[0055] Example 3

[0056] The difference between this embodiment and embodiment 1 is the shape of the support rod 6; the rest of the structure and usage process are basically the same.

[0057] In this embodiment, the shape of the support frame is the same as that in Embodiment 2, while the shape of the protective umbrella 5 is the same as that in Embodiment 1.

[0058] Example 4

[0059] The difference between this embodiment and Embodiment 1 lies in the arrangement of the nickel-titanium alloy wires; the rest of the structure and usage process are basically the same.

[0060] In this embodiment, the nickel-titanium alloy wire can be arranged both circumferentially and axially within the elastic capsule 21. This design aims to improve the accuracy of controlling the deformation of the tubular balloon 2.

[0061] In summary, the hollow balloon and protective umbrella integrated device provided by this invention solves the problems of cumbersome operation, blood flow interruption, and high risk in the prior art through integrated design, hollow cavity structure, and efficient support and interception design, and has significant clinical application value.

[0062] It is understood that the above description is merely exemplary and the embodiments of this application do not limit the scope of the application.

[0063] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention are within the protection scope of the present invention.

Claims

1. A balloon and protective umbrella integrated device of hollow structure, characterized in that, include: Push tube (1); A tubular balloon (2) is located at the distal end of the push tube (1). The tubular balloon (2) is coaxially provided with a hollow cavity (3) that runs through both ends for blood flow. The side wall of the tubular balloon (2) has a receiving chamber (4) for holding the filling medium. The protective umbrella (5) is integrally set at the far end of the tubular balloon (2) at a set distance, and is used to intercept the emboli that fall during the support of the tubular balloon (2); During operation, the tubular balloon (2) and the protective umbrella (5) are delivered synchronously with the delivery tube to reduce the number of operation steps; The tubular balloon (2) is provided with a support frame for radial expansion. The support frame passes through the tubular balloon (2) and extends to the distal end. The protective umbrella (5) is provided at the distal end of the support frame. The support frame expands radially to support the deployment of the protective umbrella (5) to intercept the embolus. When the tubular balloon (2) inflates, the support frame expands radially in sync with the tubular balloon (2), thereby causing the protective umbrella (5) to unfold, so that the protective umbrella (5) at least at the proximal opening position fits against the inner wall of the blood vessel to fully intercept the embolus.

2. The balloon and protective umbrella integrated device of claim 1, wherein, The support frame includes multiple support rods (6), which are arranged circumferentially around the cylindrical balloon (2), with the proximal end connected to the push tube (1) and the distal end connected to the protective umbrella (5).

3. The balloon and protective umbrella integrated device of claim 2, wherein, The support rod (6) has an axially extending cavity inside, which is fixedly connected to the receiving chamber (4) and is used to deliver filling medium into the receiving chamber (4).

4. The balloon and protective umbrella integrated device of claim 3, wherein, Each of the support rods (6) passes through the receiving chamber (4), and the portion of the support rod (6) passing through the receiving chamber (4) is in communication with the receiving chamber (4).

5. The hollow-structured integrated balloon and protective umbrella device according to claim 1, characterized in that, The support frame at the proximal end of the protective umbrella (5) protrudes radially outward (61) to fully support the protective umbrella (5) to adhere tightly to the blood vessel wall.

6. The hollow-structured integrated balloon and protective umbrella device according to claim 1, characterized in that, The tubular balloon (2) includes an elastic bladder (21) and a shape control component (22) for controlling the regular contraction of the elastic bladder (21).

7. The hollow-structured integrated balloon and protective umbrella device according to claim 6, characterized in that, The shape control component (22) is a nickel-titanium alloy wire disposed inside the elastic capsule (21), the nickel-titanium alloy wire being arranged at least along the circumference of the elastic capsule (21).

8. The hollow-structured integrated balloon and protective umbrella device according to any one of claims 1-7, characterized in that, The protective umbrella (5) is a membrane structure with filter holes (7) arranged on it.

9. The hollow-structured integrated balloon and protective umbrella device according to any one of claims 1-7, characterized in that, The protective umbrella (5) has a mesh woven structure, and the mesh size of the woven holes on the woven structure gradually decreases from the near end to the far end.

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