A multi-angle adjustable bronchial occluder

Abstract

This invention discloses a multi-angle adjustable bronchial occluder, relating to the field of medical device technology. It includes a catheter with a suction head connected to its distal end. A cuff assembly, fitted over the catheter, is disposed on one side of the suction head. One end of the cuff assembly is fixedly connected to the catheter, and the other end is connected to a sleeve fitted over the catheter. A bulge is integrally formed on the catheter near the cuff assembly. The cuff assembly includes: a cuff body divided into two parts connected by a nested cuff assembly; and an umbrella-shaped support assembly disposed within the cuff body to support the nested cuff assembly. This occluder exhibits high stability and is easy to operate.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-angle adjustable bronchial occluder. Background Technology

[0002] Bronchial occluders are important medical devices used in clinical practice to block the trachea or bronchial branches, maintain unilateral lung ventilation, or treat bronchopulmonary fistulas. Traditional bronchial occluders mostly use a balloon structure, achieving a tight seal against the bronchial wall through inflation. However, this design presents the following key problems in practical applications:

[0003] Traditional balloons are prone to local collapse, deformation, or weakening under long-term inflation and compression due to their material properties. This leads to a decrease in the fit with the bronchial wall and causes the risk of air leakage. This is especially prominent in surgical scenarios that require long-term occlusion (such as unilateral lung ventilation-assisted thoracic surgery). Furthermore, the smooth surface of traditional balloons results in low friction with the bronchial wall, making them prone to displacement when the patient breathes or changes position.

[0004] In addition, the suction head of the occluder is usually connected to the distal end of the catheter for intraoperative suction of secretions or postoperative drainage. However, in traditional designs, the suction head is in a fixed position and is prone to adhering to the bronchial wall due to the angle of the occluder body (such as the carina angle) or differences in the bronchus, causing the suction channel to be blocked and affecting the function.

[0005] Therefore, it is necessary to provide a bronchial occluder with multi-angle adjustment to solve the above problems. Summary of the Invention

[0006] To solve the above problems, the present invention provides the following technical solution: a multi-angle adjustable bronchial occluder, including a catheter, a suction head connected to the distal end of the catheter, a cuff assembly sleeved on the outside of the catheter on one side of the suction head, one end of the cuff assembly being fixedly connected to the catheter, and the other end being connected to a sleeve, the sleeve being sleeved on the catheter.

[0007] The catheter has an integrally formed bulge near the cuff assembly;

[0008] The sheath assembly includes:

[0009] The capsule is divided into two parts, which are connected by a capsule assembly.

[0010] An umbrella-shaped support assembly is disposed within the capsule to support the embedded capsule assembly.

[0011] Furthermore, preferably, the distal end of the catheter is connected to the suction head via an elastic post;

[0012] A first rope connects the capsule assembly to the suction head;

[0013] The first rope is installed in such a way that when the bladder assembly is supported and expanded by the umbrella-shaped support assembly, the suction head is stretched and deflected in a direction opposite to the direction of the bulge angle.

[0014] Furthermore, as a preferred embodiment, a second rope is connected between the capsule assembly and the suction head. The installation position of the second rope is configured such that when the connection of the first rope is released and the capsule assembly is supported and expanded by the umbrella-shaped support assembly, the suction head is stretched and deflected in the same direction as the bulge angle.

[0015] The second rope is an elastic rope, and the first rope is a non-elastic rope.

[0016] Furthermore, preferably, the umbrella-shaped support assembly includes:

[0017] A fixing sleeve is provided on the guide tube, and multiple first support rods are evenly distributed and hinged around the circumference of the fixing sleeve;

[0018] A sliding sleeve is slidably fitted onto the guide tube, and multiple second support rods are evenly distributed and hinged around the circumference of the sliding sleeve;

[0019] A positioning sleeve is fixedly fitted onto the conduit, and a spring fitted onto the conduit is connected between the positioning sleeve and the sliding sleeve.

[0020] The end of the second support rod away from the sliding sleeve is hinged to the corresponding first support rod.

[0021] Furthermore, as a preferred embodiment, the free end of the first support rod is hinged to a support plate, which is made of a flexible material.

[0022] Furthermore, as a preferred embodiment, a pressure sensor is embedded in the support plate.

[0023] Furthermore, as a preferred embodiment, the encapsulation assembly includes a bottom capsule and a top capsule, which together form a sealed space, wherein the bottom capsule is made of a flexible non-elastic material and the top capsule is made of a flexible elastic material.

[0024] Furthermore, as a preferred embodiment, a gas distribution seat is provided between the sleeve and the conduit, the gas distribution seat having at least two through holes, one of which is connected to the capsule assembly via a pipeline.

[0025] Furthermore, preferably, the outer surface of the bursa has spiral protrusions.

[0026] Furthermore, preferably, the outer surface of the sac is coated with a bioadhesive coating located between the spiral protrusions.

[0027] Compared with the prior art, the present invention provides a multi-angle adjustable bronchial occluder, which has the following advantages:

[0028] In this invention, the umbrella-shaped support assembly and the embedded capsule assembly work together to effectively address the problem of deformation caused by long-term pressure on traditional balloons. The mechanical deployment of the umbrella-shaped support assembly provides uniform support for the embedded capsule assembly. Combined with the characteristics of the bottom capsule maintaining its basic shape and the top capsule adapting to the irregular curved surface of the bronchial wall, a stable and tight seal is formed, reducing the risk of air leakage. At the same time, the circumferentially distributed support rod structure avoids local pressure concentration and improves the reliability of long-term use.

[0029] In this invention, a dual-mode "rigid-flexible" control system using the first and second ropes enables multi-angle deflection of the suction head, solving the problem of the suction head sticking to the wall due to the convex angle. The non-elastic rope ensures precise deflection angle, while the elastic rope absorbs traction force fluctuations, balancing operational stability and adaptability, and automatically adjusting without external intervention.

[0030] In this invention, the spiral protrusions on the outer surface of the sac increase the friction with the bronchial wall, reducing the risk of displacement caused by the patient's breathing or changes in body position; the bioadhesive coating between the spiral protrusions reduces damage to the airway mucosa by hard friction through gentle adhesion, while the biocompatible material reduces the inflammatory response, improving the safety of the occluder and the patient's comfort. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the main structure of a multi-angle adjustable bronchial occluder;

[0032] Figure 2 A schematic diagram of the planar structure of the cuff assembly in a multi-angle adjustable bronchial occluder. Figure 1 ;

[0033] Figure 3 A schematic diagram of the planar structure of the cuff assembly in a multi-angle adjustable bronchial occluder. Figure 2 ;

[0034] Figure 4 This is a schematic diagram of the planar structure of the capsule assembly in a multi-angle adjustable bronchial occluder;

[0035] In the diagram: 1. Catheter; 2. Four-way connector; 3. Papillary angle; 4. Cuff assembly; 5. Suction head; 6. Y-type connector; 7. Indicator balloon; 8. Pre-inflation assembly; 9. Sleeve; 10. Gas distribution seat; 11. Elastic column; 12. First rope; 13. Second rope; 41. Bag body; 42. Cuff assembly; 43. First support rod; 44. Second support rod; 45. Fixing sleeve; 46. Sliding sleeve; 47. Positioning sleeve; 48. Spring; 49. Support plate; 421. Bottom balloon; 422. Top balloon. Detailed Implementation

[0036] The terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such terms are interchangeable where appropriate; this is merely a way of distinguishing objects with the same attributes in the embodiments of this application. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion, so that a process, method, system, product, or apparatus that comprises a series of elements is not necessarily limited to those elements, but may include other elements not explicitly listed or inherent to those processes, methods, products, or apparatuses.

[0037] Example: Please refer to Figures 1-4 In this embodiment of the invention, a multi-angle adjustable bronchial occluder is provided, including a catheter 1. The distal end of the catheter 1 is connected to a suction head 5. A cuff assembly 4 is provided on one side of the suction head 5 and is sleeved on the outside of the catheter 1. One end of the cuff assembly 4 is fixedly connected to the catheter 1, and the other end is connected to a sleeve 9. The sleeve 9 is sleeved on the catheter 1.

[0038] The catheter 1 has an integrally formed bulge angle 3 near the cuff assembly 4;

[0039] The sheath assembly 4 includes:

[0040] Capsule 41, which is divided into two parts and the two parts are connected by a capsule assembly 42;

[0041] An umbrella-shaped support assembly is disposed in the capsule 41 to support the embedded capsule assembly 42.

[0042] Before the occluder is inserted, the gas inside the cuff assembly 4 is drawn out through the sleeve 9, causing the cuff body 41 and the embedded cuff assembly 42 to collapse due to negative pressure. At the same time, the umbrella-shaped support assembly inside the cuff body 41 is in a contracted state due to being bound by the collapsed cuff body 41 and the embedded cuff assembly 42. At this time, the overall size of the cuff assembly 4 is reduced, making it easier to insert it into the target position through the airway.

[0043] After being placed in the target position, air is supplied to the cuff assembly 4 through the sleeve 9. The cuff body 41 and the cuff assembly 42 expand due to inflation, and the umbrella-shaped support assembly, which was originally bound by the collapsed cuff body 41 and the cuff assembly 42, is released from its restraint and naturally expands to support the cuff assembly 42. The expansion of the umbrella-shaped support assembly can adjust the shape of the cuff assembly 42 to adapt to the structure of the bronchus.

[0044] In other words, in this embodiment, the morphological switching (collapse-expansion) of the cuff assembly 4 can be completed simply by performing air extraction / air supply operations through the sleeve 9, without the need for an additional power device, which reduces the complexity of the equipment and facilitates clinical operation.

[0045] The umbrella-shaped support component unfolds naturally through the mechanical structure, providing stable support for the inflatable component 42 and avoiding deformation (such as collapse or local weakness) caused by long-term pressure on the bronchial wall of traditional balloons. This maintains the fit and seal between the inflatable component 4 and the bronchial wall, reducing the risk of air leakage.

[0046] In addition, this occluder also includes components such as a four-way connector 2, a Y-type connector 6, an indicator balloon 7, and a pre-inflated assembly 8, all of which are existing structures and will not be described in detail here.

[0047] In this embodiment, the umbrella-shaped support assembly includes:

[0048] A fixing sleeve 45 is fixedly mounted on the guide tube 1, and a plurality of first support rods 43 are evenly hinged around the circumference of the fixing sleeve 45.

[0049] A sliding sleeve 46 is slidably sleeved on the guide tube 1, and multiple second support rods 44 are evenly distributed and hinged around the circumference of the sliding sleeve 46;

[0050] A positioning sleeve 47 is fixedly sleeved on the conduit 1, and a spring 48 sleeved on the conduit 1 is connected between the positioning sleeve 47 and the sliding sleeve 46.

[0051] The end of the second support rod 44 away from the sliding sleeve 46 is hinged to the corresponding first support rod 43.

[0052] Therefore, when the cuff assembly 4 is not inflated, the cuff 41 collapses, resulting in low internal pressure. At this time, the first support rod 43, affected by the collapsed cuff 41 and the cuff assembly 42, retracts inward around the hinge point of the fixing sleeve 45. Finally, all the first support rods 43 fold close to the surface of the catheter 1, and the second support rod 44 moves accordingly, driving the sliding sleeve 46 to slide towards the positioning sleeve 47 and compress the spring 48. The whole is in a compact contracted state, which facilitates the placement of the occluder into the target position through the airway.

[0053] Then, air is supplied to the bladder assembly 4 through the sleeve 9, and the bladder body 41 and the insert assembly 42 unfold. At this time, the spring 48 returns to its original state from compression and actively pushes the sliding sleeve 46 to move. The sliding sleeve 46 slides and drives the second support rod 44 to unfold outward. The second support rod 44 pushes the first support rod 43 to unfold outward around the hinge point of the fixed sleeve 45, forming an umbrella-shaped structure.

[0054] Furthermore, a support plate 49 is hinged to the free end of the first support rod 43, and the support plate 49 is made of a flexible material.

[0055] By setting the support plate 49, the support stability of the inflatable capsule assembly 42 can be improved, and the support plate 49 can also adapt to the shape of the inflatable capsule assembly 42. Specifically, the support plate 49 is made of flexible material, which can adapt to the curved shape of the inflatable capsule assembly 42 and avoid local pressure concentration caused by rigid support; at the same time, the circumferentially distributed support rods form a 360° umbrella-shaped support, which effectively alleviates the deformation (such as collapse, local thinning) caused by long-term pressure on the bronchial wall of traditional balloons, and maintains the fit and seal between the inflatable capsule assembly 4 and the bronchial wall.

[0056] Furthermore, a pressure sensor is embedded in the support plate 49.

[0057] The pressure sensor can provide real-time feedback on the contact pressure between the support plate 49 and the capsule assembly 42. Doctors can intuitively understand whether the umbrella-shaped support assembly is fully deployed and whether the support force has reached the preset value through external devices (such as a monitor).

[0058] In addition, the encapsulation assembly 42 includes a bottom capsule 421 and a top capsule 422, which together form a sealed space. The bottom capsule 421 is made of a flexible non-elastic material, and the top capsule 422 is made of a flexible elastic material.

[0059] When the umbrella-shaped support assembly supports the deployment of the bladder assembly 42, the bottom bladder 421 maintains its basic shape due to its inelastic properties, while the top bladder 422 can adjust its expansion degree according to the inflation volume due to its elastic properties, forming a curved surface that adapts to the bronchial wall.

[0060] It should also be noted that the number of support plates 49 in the umbrella-shaped support assembly needs to be balanced: an appropriate number of support plates can ensure that the encapsulated assembly 42 unfolds evenly and avoids local weakness; an excessive number will increase the manufacturing complexity and may reduce the overall stability of the encapsulated assembly 4 due to mechanical interference.

[0061] In this embodiment, a gas distribution seat 10 is provided between the sleeve 9 and the conduit 1. The gas distribution seat 10 has at least two through holes, one of which is connected to the capsule assembly 42 through a pipeline (not shown in the figure).

[0062] After the capsule assembly 42 is deployed, gas is injected into the sealed space through the through hole of the gas distribution seat 10. The inelastic properties of the bottom capsule 421 limit its over-expansion, while the elastic properties of the top capsule 422 allow it to conform to the irregular shape of the bronchial wall, forming a uniform pressure distribution and achieving a seal.

[0063] In other words, the umbrella-shaped support assembly works with the bottom bladder 421 to provide basic support, while the top bladder 422 works with the bottom bladder 421 to achieve further sealing.

[0064] Preferably, the outer surface of the sac 422 has spiral protrusions, and the outer surface of the sac 422 is coated with a bioadhesive coating located between the spiral protrusions.

[0065] It should be explained that the spiral protrusions on the outer surface of the 422 sac can increase the contact friction with the bronchial wall and reduce the risk of displacement of the occluder due to the patient's breathing or changes in body position.

[0066] The bioadhesive coating between the spiral protrusions can gently adhere to the airway mucosa, avoiding mucosal damage caused by hard friction, while reducing inflammatory response through biocompatible materials.

[0067] Furthermore, the distal end of the catheter 1 is connected to the suction head 5 via an elastic post 11;

[0068] A first rope 12 is connected between the capsule assembly 42 and the suction head 5;

[0069] The first rope 12 is configured such that when the pouch assembly 42 is supported and expanded by the umbrella-shaped support assembly, the suction head 5 is stretched and deflected in the opposite direction to the bulge angle 3.

[0070] It needs to be explained that the human trachea forms the bifurcation angle of the left and right main bronchi at the carina. The design of the bronchial occluder's carina angle 3 needs to simulate this natural angle so that when the occluder is placed at the tracheal bifurcation, it can accurately fit the tracheal wall, reduce the risk of displacement caused by angle mismatch, and ensure that the occluder is stably fixed in the target position.

[0071] However, due to the presence of the carina angle 3, after the occluder is inserted, the suction head 5 may adhere to the wall, leading to blockage of the suction head 5. In this embodiment, the distal end of the catheter 1 is connected to the suction head 5 via an elastic column 11, and a first rope 12 is connected between the capsule assembly 42 and the suction head 5. When the capsule assembly 42 is supported and expanded by the umbrella-shaped support assembly, the suction head 5 is stretched and deflected in the opposite direction to the carina angle 3, achieving multi-angle adjustment of the suction head 5, which can alleviate or resolve the wall adhesion situation.

[0072] Specifically, before the occluder is inserted, the cuff assembly 4 is in a collapsed state, the umbrella-shaped support assembly is contracted, the first rope 12 is in a relaxed state, and the suction head 5 is connected to the conduit 1 through the elastic column 11, maintaining a natural hanging or undeflected state.

[0073] When the cuff assembly 4 inflates and expands, and the umbrella-shaped support assembly supports the cuff assembly 42, the first rope 12 is stretched due to the expansion of the cuff assembly 42. Because the installation position of the first rope 12 (between the cuff assembly 42 and the suction head 5) is configured so that its stretching direction is opposite to the direction of the carina angle 3, the suction head 5 deflects in the opposite direction to the carina angle 3 under the traction of the first rope 12, avoiding excessive contact with the bronchial wall and thus mitigating the risk of blockage caused by wall adhesion. The elastic properties of the elastic column 11 allow the suction head 5 to undergo moderate deformation during traction, further adapting to local differences in the bronchial wall.

[0074] In other words, the traction mechanism of the first rope 12 directly provides a solution to the problem of the suction head 5 sticking to the wall that may be caused by the protuberance angle 3, without relying on external intervention or complex adjustments (in the existing technology, it is necessary to rely on doctors to make professional manual adjustments).

[0075] Furthermore, a second rope 13 is connected between the capsule assembly 42 and the suction head 5. The installation position of the second rope 13 is configured such that when the connection of the first rope 12 is released and the capsule assembly 42 is supported and expanded by the umbrella-shaped support assembly, the suction head 5 is stretched and deflected in the same direction as the bulge angle 3.

[0076] The second rope 13 is an elastic rope, and the first rope 12 is a non-elastic rope.

[0077] The elasticity of the elastic rope 13 can absorb the instantaneous traction force fluctuations that may occur during the expansion of the capsule assembly 42, preventing the suction head 5 from suddenly deflecting or shifting due to rigid traction, and ensuring the smoothness of the deflection action. Meanwhile, the rigid traction of the non-elastic rope 12 can control the deflection angle. The combination of the two forms a "rigid-flexible" dual-mode control, which takes into account both accuracy and adaptability.

[0078] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A multi-angle adjustable bronchial occluder, characterized in that, Includes a catheter (1), the distal end of which is connected to a suction head (5), and a cuff assembly (4) is provided on one side of the suction head (5) and sleeved outside the catheter (1). One end of the cuff assembly (4) is fixedly connected to the catheter (1), and the other end is connected to a sleeve (9). The sleeve (9) is sleeved on the catheter (1). The catheter (1) has an integrally formed bulge (3) near the cuff assembly (4); The sheath assembly (4) includes: The capsule (41) is divided into two parts, which are connected by a capsule assembly (42); An umbrella-shaped support assembly is disposed in the capsule (41) to support the embedded capsule assembly (42). The distal end of the catheter (1) is connected to the suction head (5) via an elastic post (11); A first rope (12) is connected between the capsule assembly (42) and the suction head (5). The first rope (12) is installed in such a way that when the bladder assembly (42) is supported and expanded by the umbrella-shaped support assembly, the suction head (5) is stretched and deflected in the opposite direction to the bulge angle (3). A second rope (13) is connected between the capsule assembly (42) and the suction head (5). The installation position of the second rope (13) is configured such that when the connection of the first rope (12) is released and the capsule assembly (42) is supported and expanded by the umbrella-shaped support assembly, the suction head (5) is stretched and deflected in the same direction as the bulge angle (3). The second rope (13) is an elastic rope, and the first rope (12) is a non-elastic rope; The umbrella-shaped support assembly includes: A fixing sleeve (45) is provided on the guide tube (1), and a plurality of first support rods (43) are evenly distributed and hinged on the circumference of the fixing sleeve (45). A sliding sleeve (46) is slidably mounted on the guide tube (1), and a plurality of second support rods (44) are evenly distributed and hinged on the circumference of the sliding sleeve (46). A positioning sleeve (47) is fixedly sleeved on the conduit (1), and a spring (48) sleeved on the conduit (1) is connected between the positioning sleeve (47) and the sliding sleeve (46). The end of the second support rod (44) away from the sliding sleeve (46) is hinged to the corresponding first support rod (43).

2. The multi-angle adjustable bronchial occluder according to claim 1, characterized in that, The free end of the first support rod (43) is hinged to a support plate (49), which is made of flexible material.

3. The multi-angle adjustable bronchial occluder according to claim 2, characterized in that, A pressure sensor is embedded in the support plate (49).

4. The multi-angle adjustable bronchial occluder according to claim 1, characterized in that, The encapsulation assembly (42) includes a bottom capsule (421) and a top capsule (422), which together form a sealed space. The bottom capsule (421) is made of a flexible non-elastic material, and the top capsule (422) is made of a flexible elastic material.

5. A multi-angle adjustable bronchial occluder according to claim 1, characterized in that, A gas distribution seat (10) is provided between the sleeve (9) and the conduit (1). The gas distribution seat (10) has at least two through holes, one of which is connected to the capsule assembly (42) through a pipeline.

6. A multi-angle adjustable bronchial occluder according to claim 4, characterized in that, The outer surface of the apical sac (422) has spiral protrusions.

7. A multi-angle adjustable bronchial occluder according to claim 4, characterized in that, The outer surface of the apical sac (422) is coated with a bioadhesive coating located between spiral protrusions.

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