Bronchial end-valve loader and method of operating the same

Abstract

The present application relates to the technical field of medical devices, in particular to a bronchial valve loader and its operation method. The loader comprises a top cap (1), a loading sleeve (2), a ring (3) and a loading push rod (5), the ring (3) is composed of an upper ring (32) and a lower ring (33), the lower ring (33) is integrally connected with the loading sleeve (2), the upper ring (32) is fixedly connected with the lower ring (33) through a pin (4), and the upper ring (32) rotates around the pin (4), so as to realize the opening or closing of the ring (3). The present application can make the valve fold more evenly, has a high folding success rate, and will not cause damage to the valve.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an endobronchial valve loader and its operating method. Background Technology

[0002] Precise placement of endobronchial valves is crucial for treatment effectiveness. The valve needs to be accurately positioned in the target bronchus; improper placement can lead to poor treatment results or even complications. Furthermore, valves come in various sizes and models, requiring selection based on the patient's specific lung anatomy and condition. The bronchial space is confined and complex, making the safe and accurate delivery of a suitable valve to its designated location a critical challenge.

[0003] The endobronchial valve loader, as a key tool for precise valve delivery, is of great significance in its development. It needs to possess excellent maneuverability to flexibly deliver the valve to the target bronchus under bronchoscopic guidance; simultaneously, it must ensure the stability of the valve during loading and release, preventing premature dislodgement or displacement; and it must be adaptable to the bronchial anatomy of different patients, possessing a certain degree of versatility and adjustability. The advent of the loader provides an important guarantee for the effective implementation of endobronchial valve technology and promotes the development of minimally invasive lung volume reduction therapy.

[0004] CN220898889U discloses an intrabronchial valve delivery device, specifically for delivering the intrabronchial valve disclosed in CN115531038A to a target location. CN117281653A discloses a method for loading a support-type intrabronchial valve into a delivery device using an intrabronchial valve loader, but this loader cannot load valves made entirely of silicone.

[0005] In view of the above, it is necessary to develop a new loading product that can solve the problem of loading silicone bronchial valves into the bronchus and deliver valves, while also effectively protecting the valves from damage. Summary of the Invention

[0006] In view of the above-mentioned technical status, the present invention aims to provide an intrabronchial valve loader, the loader including a top cap, a loading sleeve, a closing ring and a loading push rod, the closing ring being composed of an upper closing ring and a lower closing ring, the lower closing ring being integrally connected to the loading sleeve, one side of the upper closing ring being fixedly connected to one side of the lower closing ring by a pin, the upper closing ring rotating around the pin to realize the opening or closing of the closing ring.

[0007] In this invention, as one embodiment, the upper closing ring can rotate 180° around the pin and close with the lower closing ring, so that the loading sleeve can complete the opening and closing action.

[0008] In this invention, as one embodiment, the upper fitting ring has a through hole on one side and the lower fitting ring has a through hole on one side. The pin passes through the through hole on the upper fitting ring and the through hole on the lower fitting ring, and is fixedly connected at the end face where the pin connects to the lower fitting ring. As one embodiment, the fixed connection includes, but is not limited to, adhesive connection, riveting connection or welding connection.

[0009] In this invention, as one embodiment, the closed loop forms a channel for compressing and folding the bronchial valve.

[0010] In this invention, as one embodiment, the top cap is a cap-shaped structure with a notch, the notch extending inward to the center of the top cap, the notch being configured to a size suitable for the passage of the conduit of the conveying device, and the inner wall of the top cap being provided with threads.

[0011] In this invention, as one embodiment, the loading sleeve is a hollow cylindrical structure with threads on its front outer wall, which are connected to the top cap. The loading sleeve is integrally connected to the lower closing ring, which controls the loading sleeve to screw into the top cap. As one embodiment, the cavity diameter of the loading sleeve gradually decreases from one end to the other, wherein the cavity diameter of the loading sleeve at the end in contact with the delivery conduit is equal to or less than the inner diameter of the compression cylinder at the head end of the delivery conduit.

[0012] As one implementation scheme, the top cap and the loading sleeve are connected by a threaded connection or a snap-fit ​​connection, preferably by a threaded connection.

[0013] In this invention, as one embodiment, the loading push rod is located in the middle channel between the loading sleeve and the closing ring.

[0014] In this invention, as one embodiment, the loader can be made of metal or polymer, preferably cobalt-chromium alloy, ABS, PC or Pebax.

[0015] The present invention also provides a method for operating the above-mentioned endobronchial valve loader, the method comprising:

[0016] 1) Open the bronchial valve loader by rotating the pin, place the bronchial valve into the channel at the open end of the bronchial valve loader, close the upper and lower closure rings to close the closure rings, and place the valve inside the loader for folding.

[0017] 2) Unscrew the top cap, install the compression cylinder of the conveying device into the loading sleeve of the loader, install the top cap, and use the threaded connection to compact the compression cylinder and the loading sleeve;

[0018] 3) Insert the loading push rod to further compress the folded valve, so that the valve is loaded into the compression cylinder of the conveying device along the channel inside the loader, thus completing the loading of the valve in the bronchus.

[0019] Beneficial effects

[0020] 1. The opening and closing design of the loading sleeve and the closing ring in this invention can fold the valve to reduce its diameter;

[0021] 2. The variable diameter channel inside the loading sleeve in this invention can compress the valve inside the bronchus to a specified diameter;

[0022] 3. The notch and threaded connection design of the top cap allows the delivery conduit to pass through and compact the compression cylinder and loading sleeve at its head end;

[0023] 4. The loading sleeve of this invention does not have internal ribs, which reduces the pushing force during the pushing process and avoids damage to the valve by the internal ribs during the pushing process;

[0024] 5. The valve folds more evenly, has a high success rate, and will not damage the valve. Attached Figure Description

[0025] Figure 1 : Schematic diagram of the bronchial valve structure loaded in this invention;

[0026] Figure 2 Schematic diagram of the bronchial valve delivery system;

[0027] Figure 3 : A schematic diagram of the bronchial valve loader of the present invention with its closed and open rings;

[0028] Figure 4 : Schematic diagram of the bronchial valve folding inside the loader;

[0029] Figure 5 Schematic diagram of the compression cylinder and loading sleeve compaction of the bronchial valve delivery device;

[0030] Figure 6 : Schematic diagram of the notch and thread design of the top cap of this invention;

[0031] Figure 7 : Schematic diagram of the bronchial valve loader structure of the present invention;

[0032] Figure 8 : Schematic diagram of the upper closing ring through hole of the bronchial valve loader of the present invention;

[0033] Figure 9 : Schematic diagram of the lower closing ring through hole of the bronchial valve loader of the present invention;

[0034] Figure 10 : Schematic diagram of the lower closing ring and pin fixing of the bronchial valve loader of the present invention.

[0035] Explanation of reference numerals in the attached drawings: Top cap 1; Notch 11; Loading sleeve 2; Intermediate channel 21; Closing ring 3; Channel 31; Upper closing ring 32; Lower closing ring 33; Through hole 34; Through hole 35; Pin 4; Loading push rod 5; Valve 6; Compressed valve 61; Conveying conduit of the conveying device 7; Compression cylinder of the conveying device 40. Detailed Implementation

[0036] The following examples are provided to further illustrate the present invention, but are not intended to limit the scope of the invention in any way.

[0037] Example 1:

[0038] In this invention, as one of the embodiments, as shown in the appendix Figure 7 As shown, the bronchial valve loader in this embodiment is provided with a top cap 1, a loading sleeve 2, a closing ring 3, a pin 4, and a loading push rod 5. The loading sleeve does not have internal ribs.

[0039] like Figure 3 As shown, the closing ring 3 consists of an upper closing ring 32 and a lower closing ring 33. The lower closing ring 33 is integrally connected to the loading sleeve 2. One side of the upper closing ring 32 is fixedly connected to one side of the lower closing ring 33 by a pin 4. The fixed connection means that the upper closing ring 32 rotates around the pin 4 as an axis, thereby realizing the opening or closing of the closing ring 3.

[0040] In this invention, as one of the implementation schemes, such as Figure 3 As shown, the pin 4 and the lower closing ring 33 can be fixed by adhesive bonding, riveting, or welding. The upper closing ring 32 and the lower closing ring 33 are fixed at the pin 4, and the upper closing ring 32 can rotate axially along the pin 4, thereby realizing the opening and closing of the closing ring.

[0041] In this invention, as one of the implementation schemes, such as Figure 3 , 8 As shown in Figure 9, the upper fitting ring 32 has a through hole 34 on one side, and the lower fitting ring 33 has a through hole 35 on one side. The pin 4 passes through the through holes on the upper fitting ring 32 and the lower fitting ring 33, and is fixedly connected at the end face where the pin 4 connects to the lower fitting ring 33. Figure 10 As shown; fixed connections include adhesive connections, riveting connections, or welding connections.

[0042] The term "shaft" should be interpreted broadly. Anything that rotates along its axis can be considered a shaft. For example, in practice, a method without through holes 34 and pins 4 can be used, as long as it is ensured that the upper and lower mating rings 32 can rotate around the shaft.

[0043] In this invention, as one of the implementation schemes, such as Figure 3As shown, when the upper closing ring 32 and the lower closing ring 33 are closed, a channel 31 is formed. The channel 31 is used to accommodate the bronchial valve, and the valve is compressed and folded precisely during the process of the upper closing ring 32 and the lower closing ring 33 closing.

[0044] In this invention, as one embodiment, such as Figure 6 As shown, when assembling the loader, first fix the loading sleeve 2 and the connecting ring 3 with the pin 4. The connecting ring 3 can rotate around the pin 4 to complete the opening and closing action with the loading sleeve 2. Figure 3 Then, the top cap 1 is connected to the loading sleeve 2 by threads, and finally the loading push rod 5 is installed into the middle channel between the loading sleeve 2 and the closing ring 3 to complete the assembly.

[0045] In this invention, as one embodiment, the invention includes, but is not limited to, using... Figure 1 The bronchial valve shown is loaded into... Figure 2 The bronchial valve delivery device shown is made entirely of silicone and is approximately cylindrical.

[0046] In this invention, as one embodiment, such as Figure 3 , Figure 4 As shown, the loading sleeve 2 is a hollow cylindrical structure with threads on its front outer wall, which is connected to the top cap 1. The loading sleeve 2 is integrally connected to the lower closing ring 33. Preferably, the cavity diameter of the loading sleeve gradually decreases from one end to the other, wherein the cavity diameter of the loading sleeve at the end in contact with the delivery conduit is equal to or less than the inner diameter of the compression cylinder at the head end of the delivery conduit.

[0047] Therefore, to install the bronchial valve into a bronchial delivery device of the same specification, firstly, the closing ring 3 of the bronchial valve loader should be opened by rotating the pin 4, the bronchial valve should be placed into the open end of the bronchial valve loader, and then the closing ring 3 should be closed to fold the valve inside the loader.

[0048] In this invention, as one embodiment, such as Figure 5 As shown, unscrew the top cap 1, install the compression cylinder 40 of the conveying device into the loading sleeve 2 of the loader, and then install the top cap 1 to compact the compression cylinder and loading sleeve by means of threaded connection;

[0049] Finally, insert the loading push rod 5 to further compress the folded valve, so that the valve is loaded into the compression cylinder 40 of the conveying device along the channel inside the loader, thus completing the loading of the valve in the bronchus.

[0050] The feasibility of this invention has been demonstrated through numerous in vitro experiments, and its operability has been verified through comprehensive animal experiments. Furthermore, multiple clinical trials involving endobronchial valves have also validated the feasibility of this technology.

Claims

1. A bronchial valve loader, characterized in that, The loader includes a top cap (1), a loading sleeve (2), a closing ring (3), and a loading push rod (5). The closing ring (3) consists of an upper closing ring (32) and a lower closing ring (33). The lower closing ring (33) is integrally connected to the loading sleeve (2). One side of the upper closing ring (32) is fixedly connected to one side of the lower closing ring (33) by a pin (4). The upper closing ring (32) rotates around the pin (4) to open or close the closing ring (3).

2. The bronchial valve loader according to claim 1, characterized in that, The upper fitting ring (32) has a through hole (34) on one side and the lower fitting ring (33) has a through hole (35) on one side. The pin (4) passes through the through hole (34) on one side of the upper fitting ring (32) and the through hole (35) on one side of the lower fitting ring (33), and is fixedly connected at the end face where the pin (4) connects with the lower fitting ring (33).

3. The bronchial valve loader according to claim 2, characterized in that, The fixed connection includes adhesive connection, riveting connection or welding connection.

4. The bronchial valve loader according to claim 1, characterized in that, When the closed loop (3) is closed, it forms a channel (31) for compressing and folding the bronchial valve.

5. The bronchial valve loader according to claim 1, characterized in that, The top cap (1) is a cap-shaped structure with a notch (11) extending inward to the center of the top cap (1). The notch (11) is configured to be the size suitable for the passage of the conveying conduit (7) of the conveying device. The inner wall of the top cap (1) is provided with threads.

6. The bronchial valve loader according to claim 1, characterized in that, The loading sleeve (2) is a hollow cylindrical structure with threads on its front outer wall, which are connected to the top cap (1). The loading sleeve (2) is integrally connected to the lower closing ring (33), and the closing ring (3) controls the loading sleeve to screw into the top cap (1). Preferably, the cavity diameter of the loading sleeve (2) gradually decreases from one end to the other end, wherein the cavity diameter of the loading sleeve (2) at the end in contact with the delivery conduit is equal to or less than the inner diameter of the compression cylinder (40) at the head end of the delivery conduit (7).

7. The bronchial valve loader according to claim 1, characterized in that, The top cap (1) and the loading sleeve (2) are connected by a threaded connection or a snap-fit ​​connection, preferably by a threaded connection.

8. The bronchial valve loader according to claim 1, characterized in that, The loading push rod (5) is located in the middle channel (21) between the loading sleeve (2) and the closing ring (3).

9. The bronchial valve loader according to claim 1, characterized in that, The loader can be made of metal or polymer, preferably cobalt-chromium alloy, ABS, PC or Pebax.

10. A method for operating the endobronchial valve loader as described in claim 1, characterized in that, The method includes: 1) Rotate the closure ring (3) of the bronchial valve loader to open it by means of the pin (4), put the bronchial valve (6) into the channel (31) at the opening end of the bronchial valve loader, and close the upper closure ring (32) and the lower closure ring (33) to close the closure ring (3), so that the valve (6) is placed in the loader for folding; 2) Unscrew the top cap, install the compression cylinder (40) of the conveying device into the loading sleeve (2) of the loader, install the top cap, and compact the compression cylinder (40) and the loading sleeve (2) by means of threaded connection; 3) Insert the loading push rod (5) to further compress the folded valve, so that the valve is loaded into the compression cylinder (40) of the conveying device along the channel (21) inside the loader, thus completing the loading of the valve in the bronchus.

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