Emphysema treatment instrument and assembly

Abstract

The invention provides a pulmonary emphysema treatment instrument which comprises a main channel, the main channel comprises an air inlet, an air outlet and at least one cavity, the cavity is provided with a first necking opening and a second necking opening, the second necking opening is provided with an end face, the inner wall, close to the second necking opening, of the cavity is provided with a first point and a second point at will, and the inner wall, close to the first necking opening, of the cavity is provided with a third point and a fourth point at will. The included angle e between the ray which takes the second point as an end point and passes through the first point and the normal meets 90 degrees < = e < = 180 degrees, the included angle f between the ray which takes the third point as an end point and passes through the fourth point and the normal is smaller than 90 degrees, and a main channel is defined by the supporting framework and the covering film. The support skeleton and the covering film are combined, so that the support skeleton is stably fixed in the bronchus, the wall thickness can be reduced, the sectional area after loading is smaller, the support skeleton can be conveniently loaded into a thinner sheath tube, the support skeleton can be implanted into a smaller bronchus, and the clinical application range is wide.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a device assembly for treating emphysema. Background Technology

[0002] Emphysema is a relatively common disease, especially prevalent among the elderly. Statistics show that the 5-year survival rate for patients with end-stage emphysema is less than 50%, making effective treatment of emphysema a pressing technical challenge.

[0003] Traditional medical treatments for emphysema include oxygen therapy, prevention of lung infections, and bronchodilators, but their effectiveness is extremely limited. Surgical treatment primarily involves lung volume reduction surgery, but it also has many limitations, such as strict surgical indications, numerous complications, anesthesia and anesthesia-related complications, unpredictable preoperative efficacy, and the inability to compensate for unsatisfactory results due to excessive or insufficient resection. Furthermore, the surgery is expensive and involves significant physical and psychological suffering. Additionally, some patients with poor lung function often cannot tolerate surgery, leading to a high postoperative mortality rate. All of these factors limit the application of surgery.

[0004] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, international research has explored interventional methods such as transbronchial bio-adhesive, steam ablation, elastic coils, and one-way valves. However, each method has its limitations. For example, bio-adhesive completely blocks the emphysema area, leading to persistent postoperative inflammation; steam ablation also damages the original tissue structure of the emphysema area, causing postoperative inflammation; elastic coils, once released, cannot effectively control the lung tissue requiring compression, resulting in inaccurate treatment and additional harm to the patient; one-way valves, after implantation, control the unidirectional flow of gas in the bronchus, allowing only inflow and no outflow. However, with prolonged use, individual valves may fail due to fatigue or wear, remaining permanently open and allowing bidirectional airflow, thus worsening the emphysema condition.

[0005] In addition to the treatment options mentioned above, one-way valves made of silicone can also be implanted. However, to ensure that the silicone has sufficient radial support to be stably anchored in the bronchus, the cross-sectional area of ​​the silicone is large, and the outer diameter of the sheath is large. This means that only rigid bronchoscopes can be used for implantation, which prevents implantation in some bronchial segments and limits its clinical use.

[0006] Therefore, there is an urgent need for a pulmonary emphysema treatment device that can provide precise treatment, long-term effectiveness, minimal trauma, and a small sheath. Summary of the Invention

[0007] To overcome the above-mentioned technical problems, the present invention provides a pulmonary emphysema treatment device and component that is precise, effective in the long term, minimally invasive, and has a small sheath.

[0008] Based on the above concept, the technical solution adopted by this invention is as follows:

[0009] On one hand, the present invention provides a treatment device for emphysema, including a main channel. The main channel includes an air inlet located at a proximal end, an air outlet located at a distal end, and at least one cavity. The cavity has a first constriction communicating with the air inlet and a second constriction communicating with the air outlet. The second constriction has an end surface perpendicular to the airflow direction. A first point and a second point are arbitrarily selected on the inner wall of the cavity near the second constriction. The first point is located between the second constriction and the second point. A third point and a fourth point are arbitrarily selected on the inner wall of the cavity near the first constriction. The third point is located between the first constriction and the fourth point. A ray perpendicular to the end surface and extending distally is defined as the normal. The angle e between the ray passing through the second point and the first point and the normal satisfies 90°≤e≤180°. The angle f between the ray passing through the third point and the fourth point and the normal is less than 90°. The treatment device for emphysema also includes a supporting frame and a membrane disposed on the supporting frame. The supporting frame and the membrane form the main channel.

[0010] Preferably, the support frame includes a frame unit that covers the cavity, and the frame unit includes a first wave coil disposed at the distal end and a second wave coil disposed at the proximal end.

[0011] Preferably, the first wave coil and the second wave coil are fixedly connected.

[0012] Preferably, the first wave coil includes a plurality of support units connected in sequence, wherein each support unit includes a first bending member, a second bending member disposed at both ends of the first bending member, and a connecting rod disposed at the end of the second bending member away from the first bending member, the connecting rod being straight; and / or, adjacent support units are connected by a third bending member.

[0013] Preferably, the membrane is disposed on the inner wall and / or outer wall of the supporting frame.

[0014] Preferably, the coating includes a coating unit disposed on the skeleton unit, and the coating unit includes a first coating portion disposed on the first wavering and a second coating portion disposed on the second wavering.

[0015] Preferably, the first coating portion and the second coating portion are fixedly connected.

[0016] Preferably, the support frame is made of nickel-titanium alloy, stainless steel or cobalt-nobel alloy; and / or, the coating is made of one or more of silicone, silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene; and / or, the coating is connected to the support frame by stitching, hot pressing or wrapping.

[0017] Preferably, the emphysema treatment device further includes a pointed body disposed on the supporting frame and / or the covering membrane and used to penetrate into the bronchial tissue.

[0018] On the other hand, the present invention also provides an emphysema treatment component, comprising a plurality of emphysema treatment devices as described in any of the above claims, wherein a connector is fixed between the plurality of emphysema treatment devices, and the connector is made of one or more of the following materials: silicone, silicone ketone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene.

[0019] The present invention has at least the following beneficial effects:

[0020] This invention relates to a pulmonary emphysema treatment device. By limiting the included angle e to 90° to 180°, it diverts the gas flowing into the cavity during inhalation, reducing the flow rate and velocity of gas passing through the second constriction, thus minimizing the amount of gas entering the emphysema area. Furthermore, by limiting the included angle f to less than 90°, gas from the emphysema area is rapidly expelled from the first constriction during exhalation. Therefore, it effectively alleviates the patient's clinical symptoms and achieves precise treatment. The combination of the supporting frame and the covering membrane not only provides stable support and fixes the device securely within the bronchus but also reduces the wall thickness, resulting in a smaller cross-sectional area after loading. This allows for loading into thinner sheaths, and the device can be implanted using a flexible bronchoscope, enabling implantation into even smaller bronchi, thus broadening its clinical applicability. Attached Figure Description

[0021] Figure 1 This is a top view of one embodiment of the emphysema treatment device provided by the present invention;

[0022] Figure 2 yes Figure 1 The image shows a cross-sectional view along line AA of the emphysema treatment device provided by the present invention.

[0023] Figure 3 yes Figure 2 The image shown is a partial enlarged view of part B of the emphysema treatment device provided by the present invention.

[0024] Figure 4 yes Figure 3 The figure shown is a perspective view of the support unit of the emphysema treatment device provided by the present invention.

[0025] Figure 5 yes Figure 4The diagram shows the structural schematic of the support unit.

[0026] Figure 6 yes Figure 5 The front view of the skeleton unit of the support unit shown;

[0027] Figure 7 yes Figure 6 A three-dimensional view of the first wave loop of the skeleton unit shown;

[0028] Figure 8 yes Figure 7 The bottom view of the first wave circle shown;

[0029] Figure 9 yes Figure 8 The front view of the first wave loop shown;

[0030] Figure 10 yes Figure 9 The front view of the support unit of the first wave coil shown;

[0031] Figure 11 yes Figure 10 A three-dimensional view of the support unit shown;

[0032] Figure 12 yes Figure 6 The front view of the second wave loop of the skeleton unit shown;

[0033] Figure 13 yes Figure 12 The top view of the second wave circle shown;

[0034] Figure 14 yes Figure 2 The image shown is a front view of the support frame of the emphysema treatment device provided by the present invention.

[0035] Figure 15 yes Figure 14 A magnified view of part H shown;

[0036] Figure 16 yes Figure 4 A front view of the coating unit of the support unit shown;

[0037] Figure 17 yes Figure 16 A cross-sectional view of the coating unit shown along line LL;

[0038] Figure 18 This is a schematic diagram of the emphysema treatment device provided by the present invention after being implanted into the bronchus;

[0039] Figure 19 yes Figure 1 The image shown is a front view of another embodiment of the emphysema treatment device provided by the present invention;

[0040] Figure 20 This is a front view of an embodiment of the emphysema treatment component provided by the present invention;

[0041] Figure 21 yes Figure 20 The image shown is a top view of the emphysema treatment component provided by the present invention;

[0042] Figure 22 yes Figure 21 The diagram shown is a cross-sectional view of the emphysema treatment component provided by the present invention after implantation into the bronchus.

[0043] Explanation of icon numbers:

[0044] 100-Emphysema treatment device; 10-Support unit; 1-Support frame; 11-First wave coil; 111-Stabilizer unit; 1111-First bending component; 1112-Second bending component; 1113-Connecting rod; 1114-Third bending component; 12-Second wave coil; 2-Covering membrane; 21-First covering part; 22-Second covering part; 3-Cavity; 4-Emphysema area; 5-Bronchi; 51-Tracheal wall; 6-Inlet; 7-Outlet; 8-Connector; 9-Point; 91-First constriction; 92-Second constriction; 1000-Emphysema treatment component; a-First point; b-Second point; c-Third point; d-Fourth point; C-Starting surface; D-Ending surface; E-Normal line. Detailed Implementation

[0045] The emphysema treatment device and components provided by the present invention will be clearly and completely described below with reference to the accompanying drawings. It should be understood that the described embodiments are merely some embodiments of the present invention, not all embodiments, and the present invention can be implemented in many other ways different from those described herein.

[0046] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention.

[0047] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0048] Furthermore, in this invention, descriptions involving "first," "second," etc., are 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. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this specification, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0049] The technical solutions of the various embodiments of the present invention can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by the present invention.

[0050] In this specification, axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the component; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0051] like Figures 1 to 19 As shown, in one embodiment, the emphysema treatment device 100 of the present invention includes a main channel, the main channel including an air inlet 6 located at the proximal end, an air outlet 7 located at the distal end, and at least one cavity 3.

[0052] Preferably, the emphysema treatment device 100 is implanted into the bronchus 5 and located proximal to the emphysema area 4, thereby reducing the amount of gas entering the emphysema area 4 during inhalation and allowing the gas in the emphysema area 4 to be quickly expelled during exhalation, so as to alleviate the patient's pain and achieve an effective therapeutic effect on the emphysema area 4.

[0053] More preferably, the main channel includes an air inlet 6 located at the proximal end, which is connected to the main channel. Thus, during inhalation, the inhaled gas enters the main channel through the air inlet 6 and then decelerates and reduces the volume of the gas through the main channel.

[0054] More preferably, the main channel also includes an air outlet 7, which is located at the far end of the main channel and is connected to the main channel. During inhalation, the gas in the main channel is discharged from the air outlet 7, and during exhalation, the gas in the emphysema area 4 enters the main channel from the air outlet 7, thereby realizing the flow of gas.

[0055] More preferably, the cavity 3 is provided with at least one, specifically: there is one cavity 3, or two or more, etc. When there are multiple cavities 3, the multiple cavities 3 are arranged in sequence and connected in series in the direction from the proximal end to the distal end, so as to achieve multiple gas deceleration and volume reduction effects, and the treatment effect on emphysema is more ideal.

[0056] It should be noted that the proximal end mentioned above is the end closer to the operator, and the distal end mentioned above is the end farther away from the operator.

[0057] In one embodiment, the cavity 3 has a first constriction 91 communicating with the air inlet 6 and a second constriction 92 communicating with the air outlet 7, the second constriction 92 having an end surface D perpendicular to the airflow direction.

[0058] Preferably, the cavity 3 is located between the air inlet 6 and the air outlet 7. When inhaling, the gas enters the cavity 3 from the air inlet 6 and then exits from the air outlet 7, thereby achieving the purpose of slowing down and reducing the amount of gas inhaled into the emphysema area 4 through the cavity 3.

[0059] More preferably, the cavity 3 has a first constriction 91, which is used to communicate with the air inlet 6, so that when air is drawn in, the gas enters from the air inlet 6 into the first constriction 91 and then enters the cavity 3, thereby achieving the purpose of connecting the air inlet 6 and the cavity 3.

[0060] More preferably, the cavity 3 has a second constriction 92, which is used to communicate with the air outlet 7, so that when inhaling, gas can enter the emphysema area 4 through the second constriction 92, thereby realizing the communication between the cavity 3 and the air outlet 7.

[0061] Furthermore, such as Figure 3 As shown, the first constriction 91 has a starting surface C perpendicular to the airflow direction, which is the direction from the inlet 6 to the outlet 7. For ease of understanding, in... Figure 3 In the middle, the emphysema treatment device 100 is placed horizontally, with the proximal end being the left end of the emphysema treatment device 100 and the distal end being the right end of the emphysema treatment device 100. During inhalation, the airflow direction is horizontal to the right, and the starting surface C is perpendicular to the horizontal direction, which is the vertical direction.

[0062] Furthermore, such as Figure 3 As shown, the second constriction 92 has an ending surface D perpendicular to the airflow direction. For ease of understanding, in Figure 3 In the middle, the emphysema treatment device 100 is placed horizontally. Therefore, the airflow direction is horizontal to the right, and the ending surface D is perpendicular to the horizontal direction, which is the vertical direction.

[0063] Furthermore, when there is one cavity 3, the emphysema treatment device consists of a starting surface C, an ending surface D, and a cavity 3 located between the starting surface C and the ending surface D. The cavity 3 is composed of the starting surface C and the ending surface D. When there are multiple cavities 3, the ending surface D of the previous cavity 3 is the starting surface C of the next cavity 3, thereby realizing the connection between the cavities 3.

[0064] In this invention, "reduction" refers to the fact that the diameter of the proximal and distal ends of the cavity 3 is smaller than the diameter of other parts of the cavity 3 in the direction perpendicular to the normal E.

[0065] In one embodiment, a first point a and a second point b are arbitrarily selected on the inner wall of the cavity 3 near the second constriction 92, with the first point a located between the second constriction 92 and the second point b. A third point c and a fourth point d are arbitrarily selected on the inner wall of the cavity 3 near the first constriction 91, with the third point c located between the first constriction 91 and the fourth point d.

[0066] Preferably, both the first point a and the second point b are positioned close to the second constriction 92, with the first point a being closer to the second constriction 92 than the second point b, meaning the first point a is located between the second constriction 92 and the second point b. The distance between the first point a and the second constriction 92, and the distance between the second point b and the first point a, can be selected and set as needed, and are not specifically limited here.

[0067] More preferably, both the third point c and the fourth point d are close to the first narrowing 91, and the third point c is closer to the first narrowing 91 than the fourth point d, so that the third point c is located between the first narrowing 91 and the fourth point d. The distance between the third point c and the first narrowing 91 and the distance between the fourth point d and the third point c can be selected and set as needed, and no specific limitation is made here.

[0068] In one embodiment, the ray perpendicularly passing through the ending surface D and extending towards the distal end is defined as the normal E. The angle e between the ray F, with the second point b as its endpoint and passing through the first point a, and the normal E satisfies 90° ≤ e ≤ 180°. The angle f between the ray G, with the third point c as its endpoint and passing through the fourth point d, and the normal E is less than 90°. Figure 3 As shown.

[0069] Preferably, the normal E is perpendicular to the end surface D, and the normal E points from the air inlet 6 to the air outlet 7, which is actually the direction of gas flow in the main channel during intake.

[0070] More preferably, the ray F is centered at the second point b and passes through the first point a, with its direction pointing from the second point b to the first point a. The ray F intersects the normal E, and the angle e between the two satisfies 90°≤e≤180°. Thus, when inhalation occurs, the gas entering the cavity 3 is bounced and diverted when it reaches the second constriction 92, and part of it is diverted to a region far away from the second constriction 92. This significantly reduces the flow rate and volume of the gas discharged from the second constriction 92, preventing the aggravation of the emphysema area 4 and achieving a long-term and effective therapeutic effect.

[0071] Preferably, ray G has the third point c as its endpoint and passes through the fourth point d, and its direction is from the third point c to the fourth point d. Ray G intersects the normal E, and the angle f between the two satisfies the condition that the degree is less than 90°. Thus, during exhalation, the airflow flows from the distal end to the proximal end. The gas entering the cavity 3 flows to the first constriction 91, and a small part of the gas touches the area where the third point c and the fourth point d are located. Since the degree of the angle f is an acute angle, the flow rate and volume of the airflow are basically not weakened.

[0072] In summary, by limiting the included angles e and f as described above, the degree of airflow reduction during inhalation (airflow from proximal to distal end) is greater than the degree of airflow reduction during exhalation (airflow from distal to proximal end), thus preventing the condition of emphysema area 4 from worsening and rapidly expelling the gas within emphysema area 4.

[0073] In one embodiment, the emphysema treatment device 100 further includes a support frame 1 and a membrane 2 disposed on the support frame 1, wherein the support frame 1 and the membrane 2 form the main channel.

[0074] Preferably, the support frame 1 has multiple hollows. The support frame 1 is provided to support the membrane 2 and the bronchus 5 so as to securely fix the emphysema treatment device 100 of the present invention in the bronchus 5 and ensure its smooth functioning.

[0075] More preferably, the membrane 2 is disposed on the support frame 1 and forms the main channel, thereby sealing the internal space and preventing the gas in the internal space from being discharged from the hollow part of the support frame 1. During breathing, the gas in the bronchus 5 flows smoothly into and out of the main channel, ensuring the smooth operation of its function.

[0076] In one embodiment, the support frame 1 includes a frame unit covering the cavity 3, the frame unit including a first wave coil 11 disposed at the distal end and a second wave coil 12 disposed at the proximal end.

[0077] Preferably, one skeleton unit corresponds to one cavity 3, and the cavity 3 is disposed inside the skeleton unit, that is, the skeleton unit covers the outside of the cavity 3, forming the boundary of the cavity 3; furthermore, the skeleton unit is a component unit of the supporting skeleton 1, and the supporting skeleton 1 is composed of one or more skeleton units, thereby supporting the function of the skeleton 1.

[0078] More preferably, the skeleton unit includes a first wave coil 11, which is disposed at the far end.

[0079] More preferably, the skeleton unit further includes a second wave loop 12, which is disposed near the end of the first wave loop 11. The second wave loop 12 is a Z-shaped wave loop, such as... Figure 13 As shown, in this embodiment, the top view of the second wave loop 12 is a circular ring.

[0080] In one embodiment, the first wave coil 11 and the second wave coil 12 are fixedly connected.

[0081] More preferably, the first wave coil 11 and the second wave coil 12 are fixedly connected, such as by welding. The user can choose and set the specific fixed connection method according to the needs, and no specific limitation is made here.

[0082] Furthermore, points a, b, c, and d are points on the inner wall of the cavity 3 formed by the first wave ring 11, the second wave ring 12, and the covering membrane 2.

[0083] It should be noted that in other embodiments, the first wave coil 11 and the second wave coil 12 may not be connected, or they may be fixedly connected by stitching or the like. Users can set them according to their needs, and no specific limitation is made here.

[0084] In the case where the first wave coil 11 and the second wave coil 12 are fixedly connected, the first wave coil 11 and the second wave coil 12 can be integrally formed.

[0085] Preferably, the first wave coil 11 and the second wave coil 12 are integrally formed, which simplifies the process and improves the structural stability.

[0086] In one embodiment, the first wave coil 11 includes a plurality of sequentially connected support units 111. Each support unit 111 includes a first bending member 1111, second bending members 1112 disposed at both ends of the first bending member 1111, and a connecting rod 1113 disposed at the end of the second bending member 1112 away from the first bending member 1111. Figures 7 to 11 As shown.

[0087] Preferably, multiple support units 111 are arranged sequentially along the circumference. More preferably, multiple support units 111 are arranged at equal intervals to ensure uniform force distribution.

[0088] More preferably, the first bent member 1111 is U-shaped and located at the far end of the first wave 11, and the first bent member 1111 is located at the second constriction 92.

[0089] Preferably, there are two second bending members 1112 respectively disposed at both ends of the first bending member 1111. One end of the second bending member 1112 is fixedly connected to one end of the first bending member 1111, and the other end of the second bending member 1112 extends radially outward. Furthermore, the second bending member 1112 is also U-shaped.

[0090] More preferably, there are two connecting rods 1113 respectively disposed at the ends of the second curved member 1112 away from the first curved member 1111. One end of the connecting rod 1113 is fixedly connected to the end of the second curved member 1112 away from the first curved member 1111, and the other end of the connecting rod 1113 extends toward the proximal end and radially inward.

[0091] In one embodiment, the connecting rod 1113 is straight.

[0092] Preferably, the connecting rod 1113 is straight, so that when exhaling, the gas is blown from the distal end into the cavity 3 and onto the connecting rod 1113, thereby allowing the gas to smoothly enter the first constriction 91 and reducing the impact on the deceleration and reduction of the gas volume.

[0093] In one embodiment, adjacent support units 111 are connected by a third bending member 1114.

[0094] Preferably, the support units 111 are arranged sequentially along the circumference, and a third bending member 1114 is provided between adjacent support units 111. The third bending member 1114 is curved, and one end of the third bending member 1114 is fixedly connected to the end of the connecting rod 1113 of one support unit 111 that is away from the second bending member 1112. The other end of the third bending member 1114 is fixedly connected to the end of the connecting rod 1113 of another support unit 111 that is away from the second bending member 1112, thereby realizing the connection between two adjacent support units 111.

[0095] More preferably, in this embodiment, four support units 111 are provided and are arranged circumferentially at equal intervals, and four third bending members 1114 are provided and are arranged circumferentially at equal intervals. Each third bending member 1114 is disposed between two adjacent support units 111 for connecting two adjacent support units 111.

[0096] It should be noted that the above is a waveform structure for supporting the skeleton 1. Other supporting structures may be used in other embodiments, and no specific limitation is made here.

[0097] In one embodiment, the covering film 2 is disposed on the inner wall and / or outer wall of the supporting frame 1, such as... Figure 4 , Figure 5 , Figure 16 and Figure 17 As shown.

[0098] Preferably, the film 2 can be disposed on the inner wall of the support frame 1, or on the outer wall of the support frame 1, or simultaneously on both the inner and outer walls of the support frame 1, and the support frame 1 is used to support the film 2.

[0099] More preferably, the membrane 2 serves as an insulator to isolate the cavity 3 from the external space. The thinner and more uniform the membrane 2, the better. In this embodiment, the thickness h of the membrane satisfies 0.01mm≤h≤0.2mm, which means it can be any value between 0.01mm and 0.2mm, such as 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, 0.1mm, 0.2mm, etc. The user can choose to set it according to needs, and no specific limitation is made here.

[0100] More preferably, the thickness h of the coating 2 is 0.05mm ≤ h ≤ 0.15mm.

[0101] In one embodiment, the coating 2 includes a coating unit disposed on the skeleton unit, the coating unit including a first coating portion 21 disposed on the first wave coil 11 and a second coating portion 22 disposed on the second wave coil 12.

[0102] Preferably, the first coating portion 21 covers the first wave coil 11. Specifically, the first coating portion 21 can be disposed on the outer surface of the first wave coil 11, or on the inner surface of the first wave coil 11, or on both the outer and inner surfaces of the first wave coil 11, thereby providing an isolation effect for the cavity 3.

[0103] More preferably, the second coating portion 22 covers the second corrugated coil 12. Specifically, the second coating portion 22 can be disposed on the outer surface of the second corrugated coil 12, or on the inner surface of the second corrugated coil 12, or simultaneously on both the outer and inner surfaces of the second corrugated coil 12. The second coating portion 22 is connected to the first coating portion 21, thereby achieving the isolation effect on the first corrugated coil 11 and the second corrugated coil 12.

[0104] More preferably, the first coating portion 21 and the second coating portion 22 are integrally formed, which can simplify the process steps, improve the structural stability, and ensure the isolation effect.

[0105] It should be noted that a single cavity 3 and its corresponding skeleton unit and membrane unit constitute a support unit 10. The emphysema treatment device 100 consists of one or more support units 10 arranged in series from the proximal end to the distal end.

[0106] In one embodiment, the first coating portion 21 and the second coating portion 22 are fixedly connected.

[0107] Preferably, the first coating portion 21 and the second coating portion 22 are fixedly connected to each other, so that the coating 2 can more comprehensively cover the skeleton unit, prevent gas leakage, and ensure the stability of the structure. It can also serve as a connection when the first wave coil 11 and the second wave coil 12 are not fixedly connected.

[0108] It should be noted that in other embodiments, the first coating part 21 and the second coating part 22 may not be connected. Users can choose to set them according to their needs, and no specific limitation is made here.

[0109] In one embodiment, the support frame 1 is made of nickel-titanium alloy, stainless steel or cobalt-nodium alloy; and / or, the coating 2 is made of one or more of silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene.

[0110] Preferably, the support frame 1 is made of a biocompatible material, such as nickel-titanium alloy, stainless steel, cobalt-nodium alloy, etc. Users can choose to set it according to their needs, and no specific limitation is made here.

[0111] More preferably, the coating 2 is made of a biocompatible material, such as silicone, silicone rubber, polyurethane, polyester, or polytetrafluoroethylene, or one or more other materials. Users can choose the appropriate material as needed, and no specific limitation is made here. Furthermore, the Shore hardness of the coating 2 is any value between 0 and 40 HS, such as 1 HS, 2 HS, 3 HS, 4 HS, 5 HS, 6 HS, 7 HS, 8 HS, 9 HS, 10 HS, 20 HS, 30 HS, 40 HS, etc. Users can choose the appropriate value as needed, and no specific limitation is made here. Preferably, the Shore hardness of the coating 2 is any value between 0 and 20 HS.

[0112] In one embodiment, the membrane 2 is connected to the support frame 1 by stitching, heat pressing, or wrapping.

[0113] Preferably, the connection method between the membrane 2 and the support frame 1 can be selected and set as needed. In this embodiment, the membrane 2 and the support frame 1 can be fixedly connected by processes such as sewing, hot pressing or liquid silicone coating, which not only ensures the stability of the connection between the two, but also has mature and simple processes, simplifying the process difficulty.

[0114] In one embodiment, the proximal end of the emphysema treatment device 100 of the present invention may be provided with markings or signs to facilitate accurate identification of the air inlet 6 or the air outlet 7.

[0115] In one embodiment, an X-ray-visible material or a color-coded marker visible under direct bronchial visualization is added to the distal end of the supporting frame 1, thereby allowing for accurate determination of its position during implantation and reducing damage to the patient's bronchus 5.

[0116] like Figure 18 As shown, when using the emphysema treatment device of the present invention, there is an emphysema region 4 in the bronchus 5. The emphysema treatment device 100 of the present invention is placed in the target channel through a bronchoscope. The outer surface of the emphysema treatment device 100 is attached to the tracheal wall 51, and the air outlet 7 is closer to the emphysema region 4. During the inspiratory cycle, the airflow flows from the proximal end to the distal end. The gas flowing in through the air inlet 6 enters the cavity 3. After being diverted and rebounded at the second constriction 92, the gas flowing out of the air outlet 7 is effectively slowed down and its volume reduced, that is, the amount of gas flowing into the emphysema region 4 is reduced. During the expiratory cycle, the airflow flows from the distal end to the proximal end. The gas entering through the air outlet 7 is discharged from the air inlet 6 with a slight reduction in flow rate and volume. Therefore, the emphysema treatment device of this invention can block inhaled air while allowing exhaled airflow and mucus cleared from the treated airway to pass through. This solves the problems of chest tightness and chest pain that occur in unidirectional blockade therapy, alleviating the clinical symptoms of emphysema patients. Simultaneously, it ensures that the pathological gas is rapidly expelled through gradual pressurization of the exhaled airflow. Furthermore, the emphysema treatment device of this invention uses a combination of a supporting frame 1 and a membrane 2, resulting in a thinner wall thickness and a smaller cross-sectional area after loading. This allows it to be loaded into thinner sheaths and can be implanted using a flexible bronchoscope, enabling implantation into smaller bronchi and broadening its clinical applicability.

[0117] In one embodiment, such as Figure 19 As shown, the emphysema treatment device 100 also includes a pointed body 9 disposed on the supporting frame 1 and / or the covering membrane 2 and used to penetrate into the bronchial tissue.

[0118] Preferably, in order to securely fix the emphysema treatment device 100 to the inner wall of the bronchus 5, a pointed body 9 can be provided in the area where the emphysema treatment device contacts the bronchus 5, so that the pointed body 9 can penetrate into the tissue of the inner wall of the bronchus 5 to securely fix the emphysema treatment device in the bronchus 5, effectively extending its service life.

[0119] More preferably, the area of ​​the end of the pointed body 9 away from the emphysema treatment device 100 is smaller than the area of ​​the pointed body 9 near the emphysema treatment device 100. For example, the end of the vertebral body or the pointed body 9 away from the emphysema treatment device 100 is designed with rounded corners, which is conducive to penetrating into the tissue and reducing damage to the bronchus 5.

[0120] More preferably, the pointed body 9 can be disposed on the outer surface of the support frame 1, or on the outer surface of the membrane 2, or simultaneously on the outer surfaces of the support frame 1 and the membrane 2, so as to meet different needs. Furthermore, it is preferable to provide multiple pointed bodies 9, which can be distributed at equal intervals, such as circumferentially or axially, or dispersedly. Users can choose to set them according to their needs, and no specific limitation is made here.

[0121] More preferably, the pointed body 9 is fixed to the supporting frame 1 and / or the membrane 2 by adhesive bonding, or it can be fixed by other methods such as integral molding. Users can choose the setting according to their needs, and no specific limitation is made here.

[0122] In another embodiment, such as Figures 20 to 22 As shown, the present invention also provides an emphysema treatment component 1000, which includes a plurality of emphysema treatment devices 100, which are arranged sequentially in the circumferential direction. Preferably, the plurality of devices are arranged at equal intervals in the circumferential direction to ensure uniform distribution.

[0123] More preferably, multiple emphysema treatment devices 100 are connected in parallel, thereby achieving deceleration and volume reduction of the gas inhaled into the bronchus 5 through multiple main channels. Even if one of them is damaged, the others can still be used normally, ensuring the long-term effectiveness of the treatment.

[0124] More preferably, a connector 8 is provided between the multiple emphysema treatment devices 100. The connector 8 is used to connect the multiple emphysema treatment devices 100 and can seal the gaps between the multiple emphysema treatment devices 100 to prevent gas from passing through. Furthermore, the connector 8 is preferably made of a biocompatible material, such as silicone, silicone rubber, polyurethane, polyester, or polytetrafluoroethylene, or one or more of these materials.

[0125] More preferably, the connector 8 is in the form of a thin film, and the shape of the connector 8 is adapted to the shape of the space between the plurality of emphysema treatment devices 100. The connector 8 is fixedly connected to the side of the plurality of emphysema treatment devices 100 so as to seal the gap between the plurality of emphysema treatment devices 100 and prevent gas from passing through the gap, so that gas passes through the emphysema treatment devices 100.

[0126] like Figure 22As shown, after multiple emphysema treatment devices 100 are implanted into the bronchus 5, each emphysema treatment device 100 is fan-shaped, and multiple emphysema treatment devices 100 are combined into a circle and rest against the inner surface of the tracheal wall 51. The connector 8 is located between multiple emphysema treatment devices 100, so as to realize multiple deceleration and volume reduction of the gas flowing into the bronchus 5, enhance the treatment effect, and ensure long-term effective treatment effect.

Claims

1. A device for treating emphysema, characterized in that, The device includes a main channel, comprising an air inlet at a proximal end, an air outlet at a distal end, and at least one cavity. The cavity has a first constriction communicating with the air inlet and a second constriction communicating with the air outlet. The second constriction has an ending surface perpendicular to the airflow direction. Two arbitrary points are selected on the inner wall of the cavity near the second constriction, with the first point located between the second constriction and the second point. Two arbitrary points are selected on the inner wall of the cavity near the first constriction, with the third point located between the first constriction and the fourth point. A ray perpendicular to the ending surface and extending distally is defined as the normal. The angle e between the ray passing through the second point and the first point and the normal satisfies 90°≤e≤180°. The angle f between the ray passing through the third point and the fourth point and the normal is less than 90°. The emphysema treatment device also includes a supporting frame and a covering disposed on the supporting frame. The supporting frame and the covering form the main channel.

2. The emphysema treatment device according to claim 1, characterized in that, The supporting skeleton includes a skeleton unit that covers the cavity, and the skeleton unit includes a first wave coil disposed at the distal end and a second wave coil disposed at the proximal end.

3. The emphysema treatment device according to claim 2, characterized in that, The first wave coil and the second wave coil are fixedly connected.

4. The emphysema treatment device according to claim 2 or 3, characterized in that, The first wave coil includes a plurality of support units connected in sequence, wherein each support unit includes a first bending member, a second bending member disposed at both ends of the first bending member, and a connecting rod disposed at the end of the second bending member away from the first bending member, the connecting rod being straight; and / or, adjacent support units are connected by a third bending member.

5. The emphysema treatment device according to claim 4, characterized in that, The membrane is disposed on the inner wall and / or outer wall of the supporting frame.

6. The emphysema treatment device according to claim 2 or 3, characterized in that, The coating includes a coating unit disposed on the skeleton unit, and the coating unit includes a first coating portion disposed on the first wavering and a second coating portion disposed on the second wavering.

7. The emphysema treatment device according to claim 6, characterized in that, The first coating part is fixedly connected to the second coating part.

8. The emphysema treatment device according to claim 7, characterized in that, The supporting frame is made of nickel-titanium alloy, stainless steel or cobalt-nobel alloy; and / or the coating is made of one or more of silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene; and / or the coating is connected to the supporting frame by stitching, hot pressing or wrapping.

9. The emphysema treatment device according to claim 8, characterized in that, The emphysema treatment device also includes a pointed body disposed on the supporting frame and / or the covering membrane and used to penetrate into the bronchial tissue.

10. A treatment component for emphysema, characterized in that, The invention includes multiple emphysema treatment devices as described in any one of claims 1 to 9, wherein a connector is fixed between the multiple emphysema treatment devices, the connector being made of one or more of the following materials: silicone, silicone ketone, silicone rubber, polyurethane, polyester, or polytetrafluoroethylene.

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