Emphysema treatment instrument

Abstract

The invention provides a pulmonary emphysema treatment instrument which comprises a treatment part, a fixing frame and a connecting part connecting the treatment part and the fixing frame, the treatment part comprises a frame body, the connecting part is arranged between the fixing frame and the frame body, and the connecting part blocks a gap between the fixing frame and the frame body. The fixing frame is arranged on the frame body of the treatment piece, so that the treatment piece is stably fixed in the bronchus, effective treatment of emphysema is achieved, the service life of the treatment piece is prolonged, meanwhile, the connecting piece is arranged between the fixing frame and the frame body, connection of the fixing frame and the frame body is achieved, and a gap between the fixing frame and the frame body can be blocked; therefore, all the gas passes through the treatment piece, and the treatment effect on emphysema is ensured.

Description

Technical Field

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

[0002] Emphysema is a 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%. Treatment methods for emphysema mainly include medical and surgical approaches. Medical treatments include oxygen therapy, prevention of lung infections, and bronchodilators, but their effectiveness is 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 outcomes, inability to compensate for unsatisfactory results due to excessive or insufficient resection, high surgical costs, and significant physical and psychological suffering. Furthermore, some patients with poor lung function often cannot tolerate surgery, resulting in a high postoperative mortality rate, which limits the application of surgical procedures.

[0003] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, international research has focused on implanting medical devices, such as one-way valves and one-way valves, into the bronchi to prevent the condition from worsening and even improve it. However, existing implantable medical devices typically have a fixed diameter and are not compatible with the diameter of the bronchi, thus failing to securely fix themselves within the bronchi and affecting the treatment efficacy for emphysema. Summary of the Invention

[0004] To overcome the above-mentioned technical problems, the present invention provides a pulmonary emphysema treatment device that can be stably fixed in the bronchus.

[0005] As conceived above, the technical solution adopted by the present invention is: a pulmonary emphysema treatment device, comprising a treatment component, a fixed frame, and a connector connecting the treatment component and the fixed frame. The treatment component includes a frame body, and the connector is disposed between the fixed frame and the frame body, thereby sealing the gap between the fixed frame and the frame body.

[0006] The present invention has at least the following beneficial effects:

[0007] The emphysema treatment device of the present invention is fixedly fixed in the bronchus by setting a fixing frame on the frame of the treatment device, thereby achieving effective treatment of emphysema and extending its service life. At the same time, a connecting piece is set between the fixing frame and the frame, which not only realizes the connection between the fixing frame and the frame, but also seals the gap between the fixing frame and the frame, so that all the gas passes through the treatment device, ensuring the therapeutic effect on emphysema. Attached Figure Description

[0008] Figure 1 This is a top view of the first embodiment of the emphysema treatment device of the present invention;

[0009] Figure 2 yes Figure 1 The image shows a front view of the emphysema treatment device of the present invention;

[0010] Figure 3 yes Figure 2 The image shows a cross-sectional view of the emphysema treatment device of the present invention along line AA.

[0011] Figure 4 yes Figure 3 The image shows a front view of the fixing frame and connecting parts of the emphysema treatment device of the present invention;

[0012] Figure 5 yes Figure 3 The figure shows a cross-sectional view of the treatment component of the emphysema treatment device of the present invention;

[0013] Figure 6 yes Figure 5 The image shown is a partial enlarged view of one embodiment of part B of the emphysema treatment device of the present invention.

[0014] Figure 7 yes Figure 6 A partially enlarged view of another embodiment of part B of the emphysema treatment device of the present invention is shown.

[0015] Figure 8 yes Figure 3 A front view of another embodiment of the treatment component of the emphysema treatment device of the present invention is shown;

[0016] Figure 9 This is a top view of a second embodiment of the emphysema treatment device of the present invention;

[0017] Figure 10 yes Figure 9 The diagram shows a top view of the emphysema treatment device of the present invention.

[0018] Figure 11 This is a front view of the third embodiment of the emphysema treatment device of the present invention;

[0019] Figure 12 yes Figure 11 The diagram shows a top view of the emphysema treatment device of the present invention;

[0020] Figure 13 This is a front view of the fourth embodiment of the emphysema treatment device of the present invention;

[0021] Figure 14 yes Figure 13 The image shows a top view of the emphysema treatment device of the present invention.

[0022] Explanation of reference numerals in the attached figures:

[0023] 1-Therapeutic component; 11-Third skeleton; 12-Third membrane; 13-Air inlet; 14-Air outlet; 15-Mesh; 2, 2', 2”-Fixing frame; 21-First skeleton; 22-First membrane; 3, 3', 3”-Connector; 31-Second skeleton; 32-Second membrane; 4-Cavity; 5-Point; a-First point; b-Second point; c-Third point; d-Fourth point; C-Normal line. Detailed Implementation

[0024] The emphysema treatment device 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] like Figures 1 to 8As shown, in one embodiment, the emphysema treatment device of the present invention includes a treatment component 1, a fixing frame 2, and a connector 3 connecting the treatment component 1 and the fixing frame 2.

[0031] Preferably, the treatment device 1 is an implantable medical device used in the bronchus containing the emphysema area. This allows it to slow down and reduce the volume of inhaled gas into the emphysema area, minimizing damage. Alternatively, it can simultaneously expel gas from the emphysema area rapidly, preventing gas accumulation and its impact on improvement and recovery. The treatment device 1 is preferably positioned within the bronchus in the proximal region of the emphysema. It should be noted that "proximal" refers to the end closer to the operator, and "distal" refers to the end furthest from the operator; these are commonly used terms in the industry and will not be elaborated further here.

[0032] More preferably, the fixing frame 2 is disposed inside the bronchus, and the outer surface of the fixing frame 2 abuts against the inner wall of the bronchus, thereby being securely fixed inside the bronchus. The diameter of the outer peripheral surface of the fixing frame 2 is slightly larger than the diameter of the inner wall of the bronchus, so as to securely fix it inside the bronchus.

[0033] It should be noted that the aforementioned fixed frame 2 allows the diameter of the treatment component 1 to be designed to be smaller than that of the bronchus. This eliminates the need for the treatment component 1 to adapt to changes in the bronchus diameter during respiration, enabling it to stably decelerate and reduce the volume of gas, thus ensuring the therapeutic effect on emphysema. At the same time, it prevents the treatment component 1 from being unable to adapt to bronchus with a larger diameter due to its smaller diameter, thereby expanding its application range.

[0034] Preferably, one end of the connector 3 is fixedly connected to the fixed frame 2, and the other end of the connector 3 is fixedly connected to the treatment component 1, thereby achieving a stable connection between the fixed frame 2 and the treatment component 1. This ensures that when the fixed frame 2 is fixed inside the bronchus, the treatment component 1 can also be firmly fixed inside the bronchus, extending its service life and preventing the treatment component 1 from moving back and forth inside the bronchus during breathing, thus affecting the treatment effect on emphysema.

[0035] In one embodiment, the treatment component 1 includes a frame, and the connector 3 is disposed between the fixing frame 2 and the frame, wherein the connector 3 seals the gap between the fixing frame 2 and the frame, such as... Figures 1 to 3 As shown.

[0036] Preferably, the treatment component 1 includes a frame with internal channels for slowing and reducing airflow, thereby achieving a therapeutic effect on the emphysema area. Furthermore, the frame is a hollow shell with openings at both axial ends to facilitate gas entry and exit.

[0037] More preferably, the connector 3 is located between the fixed frame 2 and the frame body, thereby connecting the fixed frame 2 and the frame body, and then fixing the frame body inside the bronchus through the fixed frame 2 to achieve the purpose of fixing the frame body inside the bronchus. The connector 3 mainly serves the purpose of connection.

[0038] Preferably, the connector 3 seals the gap between the fixing frame 2 and the frame body, thereby preventing gas in the bronchus from flowing out through the gap between the fixing frame 2 and the frame body during breathing. This allows all the gas to flow through the frame body, thus slowing down and reducing the amount of gas flowing into the emphysema area, and quickly expelling the gas from the emphysema area, ensuring the therapeutic effect on the emphysema area. Figure 3 As shown.

[0039] More preferably, one, two or more connectors 3 can be provided. When one connector 3 is provided, it can not only connect the fixed frame 2 to the frame body and seal the gap between the fixed frame 2 and the frame body, but also reduce costs. When multiple connectors 3 are provided, the connection between the fixed frame 2 and the frame body is more stable and the sealing effect is more ideal.

[0040] In one embodiment, the fixing frame 2 is cylindrical, and the diameter of the fixing frame 2 is larger than the diameter of the frame body, such as... Figure 3 As shown.

[0041] Preferably, the fixing frame 2 is a cylinder, which can adapt to the bronchus so that the outer surface of the fixing frame 2 fully abuts against the inner wall of the bronchus, so as to securely fix the fixing frame 2 inside the bronchus.

[0042] It should be noted that the fixing frame 2 can also be other geometric shapes, as long as it can be fixed inside the bronchus. Users can choose to set it according to their needs, and no specific limitation is made here.

[0043] More preferably, the diameter of the fixing frame 2 is larger than the diameter of the frame body. Specifically, the maximum diameter of the outer surface of the fixing frame 2 is larger than the maximum diameter of the outer surface of the frame body, so that the fixing frame 2 can be firmly fixed inside the bronchus, so as to firmly fix the frame body inside the bronchus.

[0044] In one embodiment, the fixing frame 2 includes a first skeleton 21, such as... Figures 1 to 4 As shown.

[0045] Preferably, the first frame 21 serves as a support to ensure a stable fit against the inner wall of the bronchus, resulting in significant fixation.

[0046] More preferably, the specific form of the first skeleton 21 can be selected and set as needed. Several common forms are listed below:

[0047] The first form: The first skeleton 21 is a woven mesh, which is woven from one or more metal or non-metal wires. The weaving form and process can be common in the market and are not specifically limited here. The woven mesh first skeleton 21 not only ensures strength but also simplifies the process. At the same time, it is highly elastic and can adapt to the diameter changes of the bronchi during breathing, so as to better adapt to the internal environment of the bronchi and extend its service life.

[0048] The second form: The first frame 21 includes multiple wave rings and a connecting rod disposed between two adjacent wave rings. The connecting rod is used to connect two adjacent wave rings. The wave rings and the connecting rods can be integrally formed or welded together. Through the setting of the wave rings and the connecting rods, they can be stably fixed in the bronchus. The process and structure are simple and the structure is stable.

[0049] The third form: The first frame 21 is a frame structure with several mesh holes on its outer surface. The mesh holes can be formed by drilling holes in the frame with a laser. This process is simple, easy to process, and conducive to improving production efficiency. In addition, the structure is stable and can be firmly fixed inside the bronchus.

[0050] It should be noted that the specific form of the first skeleton 21 can be selected and set as needed, as long as it can be stably fixed in the bronchus, and no specific limitation is made here.

[0051] More preferably, the first skeleton 21 is made of a material with good biocompatibility and good support performance, such as nickel-titanium alloy, stainless steel, cobalt-nodium alloy, silicone, silicone rubber, etc. The specific material selection can be set as needed and is not specifically limited here.

[0052] More preferably, the first frame 21 can be a cylinder, an elliptical cylinder, or other geometric shapes. Preferably, the shape of the first frame 21 is adapted to the shape of the inner wall of the bronchus so that the first frame 21 can fully abut against the inner wall of the bronchus, which is conducive to being firmly fixed inside the bronchus.

[0053] In one embodiment, the fixing frame 2 further includes a first covering film 22 fixed to the inner wall and / or outer wall of the first skeleton 21, such as Figures 1 to 4 As shown.

[0054] Preferably, one first film 22 can be provided and fixed to the inner or outer wall of the first frame 21, or two first films 22 can be provided and fixed to the inner and outer walls of the first frame 21 respectively. The specific location of the first film 22 can be selected as needed and is not specifically limited here.

[0055] It should be noted that when the first membrane 22 is disposed on the outer surface of the first skeleton 21, the outer surface of the first membrane 22 abuts against the inner wall of the bronchus, thereby better combining with the bronchus, reducing damage to the bronchus, and extending its service life.

[0056] More preferably, the first coating 22 can fully cover the first skeleton 21 in the axial direction, or multiple coatings can be set and arranged at intervals in the axial direction. Users can choose to set them as needed, and no specific limitation is made here.

[0057] It should be noted that the first covering 22 may only cover the supporting part of the first skeleton 21, such as the part of the first skeleton 21 that contacts the inner wall of the bronchus, thereby reducing the stimulation caused by the first skeleton 21 directly contacting the bronchus with an excessively large area, which may lead to inflammation, granulation tissue growth, and difficulty in subsequent removal.

[0058] More preferably, the first membrane 22 is made of a biocompatible material, such as one or more combinations of silicone, silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene, so as to integrate well with the bronchus, reduce the impact on the bronchus, and ensure its long-term effective treatment effect on emphysema.

[0059] More preferably, the connection between the first membrane 22 and the first skeleton 21 can be achieved by stitching, hot pressing, or wrapping, which is not only simple but also provides a stable connection, resulting in high overall structural strength.

[0060] In one embodiment, the connector 3 includes a second membrane 32, one end of which is fixedly connected to the fixing frame 2, and the other end of which is fixedly connected to the frame body; and / or, the connector 3 includes a second skeleton 31, one end of which is fixedly connected to the fixing frame 2, and the other end of which is fixedly connected to the frame body, such as... Figure 3 As shown.

[0061] When the connector 3 only includes the second membrane 32, the following specific description is given for this embodiment:

[0062] Preferably, the second covering 32 is disposed between the fixing frame 2 and the frame body to connect the fixing frame 2 and the frame body, so that when the fixing frame 2 is fixed in the bronchus, the frame body is fixed in the bronchus.

[0063] More preferably, one end of the second membrane 32 is fixedly connected to the fixing frame 2. Specifically, when the fixing frame 2 only includes the first skeleton 21, one end of the second membrane 32 is fixedly connected to the first skeleton 21, such as to the inner wall, outer wall, or axial end of the first skeleton 21, so as to fix the connector 3 to the fixing frame 2. Preferably, the second membrane 32 is fixedly connected along the edge of the first skeleton 21 to better seal the gap with the bronchial wall, thereby ensuring that the gas passes through the treatment piece 1 during breathing to achieve a good therapeutic effect. When the fixing frame 2 includes the first membrane 22, one end of the second membrane 32 is fixedly connected to the first membrane 22, or one end of the second membrane 32 is fixedly connected to both the first skeleton 21 and the first membrane 22, thereby fixing the connector 3 to the fixing frame 2.

[0064] More preferably, the other end of the second film 32 is fixedly connected to the frame, specifically: the second film 32 is fixedly connected to the outer surface or end face of the frame, etc.

[0065] More preferably, when the frame includes a third film 12 and a third skeleton 11, the second film 32 is fixedly connected to the outer surface of the third film 12, or fixedly connected to the outer surface of the third skeleton 11, or fixedly connected to both the third film 12 and the third skeleton 11, thereby achieving a stable connection between the frame and the connector 3. In other embodiments, the connection method between the connector 2 and the frame can be selected and set as needed, and is not specifically limited here.

[0066] Furthermore, the second membrane 32 is preferably made of a biocompatible material, such as one or more combinations of silicone, silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene, to better adapt to the environment inside the bronchus. The specific material selection can be set by the user as needed, and no specific limitation is made here.

[0067] Furthermore, through holes (not shown) can be provided on the second membrane 32. These through holes are distributed on the second membrane 32, preferably evenly distributed. The ratio 'a' of the area of ​​the through holes to the area of ​​the second membrane 32 satisfies 1% ≤ a ≤ 75%, meaning it can be any value between 1% and 75%, such as 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, etc. Users can choose the setting according to their needs; no specific limitation is made here. It should be noted that the preferred range of the above ratio 'a' is 1% to 40%, thus not only achieving the connection between the fixing frame 2 and the frame body, but also allowing most of the gas to pass through the treatment component 1, achieving the treatment of emphysema, and also playing a diversion role when the airflow is large. It should be noted that the area of ​​the second membrane 32 is the total area of ​​the outer surface of the membrane (including all through holes), and the area of ​​the through holes is the total area of ​​all through holes.

[0068] When the connector 3 only includes the second frame 31, the following specific description is given for this embodiment:

[0069] Preferably, the second frame 31 is disposed between the fixed frame 2 and the frame body to connect the fixed frame 2 and the frame body, so that when the fixed frame 2 is fixed inside the bronchus, the frame body is fixed inside the bronchus.

[0070] More preferably, one end of the second frame 31 is fixedly connected to the fixed frame 2. Specifically, when the fixed frame 2 only includes the first frame 21, one end of the second frame 31 is fixedly connected to the first frame 21, such as to the inner wall, outer wall, or axial end of the first frame 21, so as to fix the connector 3 to the fixed frame 2. Preferably, the second frame 31 is fixedly connected along the edge of the first frame 21 to better achieve the connection between the two. When the fixed frame 2 includes the first film 22, one end of the second frame 31 is fixedly connected to the first film 22, or one end of the second frame 31 is fixedly connected to both the first frame 21 and the first film 22, thereby fixing the connector 3 to the fixed frame 2.

[0071] More preferably, the other end of the second frame 31 is fixedly connected to the frame body, specifically: the second frame 31 is fixedly connected to the outer surface or end face of the frame body, etc.

[0072] More preferably, when the frame includes a third film 12 and a third skeleton 11, the second skeleton 31 is fixedly connected to the outer surface of the third film 12, or fixedly connected to the outer surface of the third skeleton 11, or fixedly connected to both the third film 12 and the third skeleton 11, thereby achieving a stable connection between the frame and the connector 3. In other embodiments, the connection method between the connector 2 and the frame can be selected and set as needed, and no specific limitation is made here.

[0073] Furthermore, the second frame 31 is made of biocompatible materials, such as nickel-titanium alloy, stainless steel, cobalt-nodium alloy, silicone, silicone rubber, polypropylene, nylon, etc. The specific material selection can be set according to needs and is not specifically limited here. Preferably, materials such as polypropylene and nylon have a certain supporting function, low rigidity, and are relatively soft, which can reduce the impact on the size of the treatment component 1 when the diameter of the fixation frame 2 changes with the diameter of the bronchus.

[0074] Furthermore, the second frame 31 can be provided with through holes (not shown). For example, the second frame 31 can be a mesh formed by woven yarns, or it can be a wavy circle, etc. The ratio b of the area of ​​the through hole to the area of ​​the second frame 31 satisfies 1% ≤ b ≤ 75%, that is, it can be any value between 1% and 75%, such as 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, etc. The user can choose to set it according to needs, and no specific limitation is made here. It should be noted that the preferred range of the above ratio b is 1% to 40%, so as not only to realize the connection between the fixed frame 2 and the frame body, but also to allow most of the gas to pass through the treatment component 1 to realize the treatment of emphysema. At the same time, it can also play a diversion role when the airflow is large. It should be noted that the area of ​​the above through holes is the total area of ​​all through holes, and the area of ​​the second frame 31 is the total area of ​​the outer surface of the frame (including all through holes).

[0075] It should be noted that the connector 3 may also include the second frame 31 and the second membrane 32. In this case, both ends of the second frame 31 and both ends of the second membrane 32 may be fixedly connected to the fixed frame 2 and the frame body. Alternatively, both ends of the second frame 31 or the second membrane 32 may be fixedly connected to the fixed frame 2 and the frame body respectively. Users can set it according to their needs, and no specific limitation is made here.

[0076] In one embodiment, the second membrane 32 is fixed to the inner wall and / or outer wall of the second skeleton 31, such as... Figure 3 As shown.

[0077] Preferably, one second frame 31 can be provided and fixed to the inner or outer wall of the second membrane 32; two second frames 31 can also be provided and fixed to the inner and outer walls of the second membrane 32, thereby significantly enhancing the structural strength and extending its service life.

[0078] In other embodiments, two second membranes 32 may be provided and fixed on both sides of the second frame 31 to achieve a better sealing effect, enhance the effect of sealing the gap between the fixing frame 2 and the frame body, and facilitate the complete passage of gas through the frame body.

[0079] More preferably, the second skeleton 31 and the second membrane 32 are connected by processes such as sewing, hot pressing or wrapping, which not only makes the process simple but also makes the connection stable, thereby making the overall structure stronger.

[0080] In one embodiment, the frame includes a third skeleton 11, which has a plurality of mesh openings 15. The area of ​​each mesh opening 15 is S1, and the outer surface area of ​​the third skeleton 11 is S2, wherein 1% ≤ S1 / S2 ≤ 75%. Figure 8 As shown.

[0081] Preferably, the third skeleton 11 can be a mesh woven from braided yarns, or it can be composed of multiple interconnected wavy circles, etc. For details, refer to the first skeleton 21. The specific structure and form of the second skeleton 31 can be selected and set as needed, and are not specifically limited here.

[0082] More preferably, the third frame 11 can be fixedly connected to the second frame 31 or to the second membrane 32, thereby achieving a stable connection between the connector 3 and the frame and enhancing the overall structural strength.

[0083] More preferably, the third skeleton 11 is made of a biocompatible material, such as nickel-titanium alloy, stainless steel, cobalt-nodium alloy, silicone, silicone, silicone rubber, polypropylene, or nylon. The specific material selection can be set as needed and is not specifically limited here.

[0084] More preferably, the mesh 15 is provided in multiple sizes and distributed on the outer surface of the third frame 11. The mesh 15 penetrates the inner and outer surfaces of the third frame 11. Preferably, the multiple mesh 15 are evenly distributed on the third frame 11, so as to not only reduce costs, but also reduce weight.

[0085] Furthermore, the shape of the mesh 15 can be circular, square, polygonal, etc., and the mesh 15 can also be set with a combination of multiple shapes. Users can choose to set it according to their needs, without making specific limitations here.

[0086] Furthermore, by limiting the ratio of the total area of ​​the mesh 15 to the outer surface area of ​​the third skeleton 11 to 1% to 75%, it is possible not only to ensure that the flow rate and volume of the gas entering the interior are reduced to a certain extent, but also to facilitate the subsequent granulation tissue of the tracheal wall to climb over the mesh 15. Given enough time, the granulation tissue can completely cover the mesh 15, thereby isolating it from the external space, ensuring the reduction of the flow rate and volume of the airflow, and gradually sealing its internal space, so that the gas in the lung lobe can be slowly discharged, thereby reducing the incidence of pneumothorax.

[0087] It should be noted that the ratio of the total area of ​​the mesh 15 to the outer surface area of ​​the third frame 11 can be any value between 1% and 75%, such as 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, etc. Users can choose and set according to their needs, and no specific limitation is made here. It should be noted that the total area of ​​the mesh 15 is the total area of ​​all meshes, and the outer surface area of ​​the third frame 11 is the total area of ​​the outer surface of the frame (including all meshes 15).

[0088] It should be further noted that the ratio S1 / S2 of the total area of ​​the mesh 15 to the outer surface area of ​​the third skeleton 11 is limited to 1% to 40%, which has the best effect on decelerating and reducing airflow, achieving a significant therapeutic effect on emphysema, reducing damage to emphysema, and is beneficial for the treatment of emphysema and effectively reducing the incidence of pneumothorax.

[0089] In one embodiment, the frame includes a third covering 12.

[0090] Preferably, the third membrane 12 is made of a biocompatible material, such as one or more combinations of silicone, silicone rubber, polyurethane, polyester or polytetrafluoroethylene, to better adapt to the environment inside the bronchus. The specific material selection can be set by the user as needed, and no specific limitation is made here.

[0091] More preferably, the third membrane 12 can be fixedly connected to the second frame 31 or the second membrane 32, thereby achieving a stable connection between the connector 3 and the frame and enhancing the overall structural strength.

[0092] More preferably, through holes (not shown) can also be provided on the third coating 12. Multiple through holes are provided and distributed on the third coating 12, preferably evenly distributed, which not only helps to reduce costs but also reduces weight. Furthermore, the shape of the through holes can be circular, square, polygonal, etc., and multiple shapes of through holes can also be provided in combination. Users can choose to set them according to their needs, and no specific limitation is made here.

[0093] Further preferably, the ratio c of the area of ​​the through hole to the total area of ​​the third membrane 12 is limited to between 1% and 75%. This not only ensures that the flow rate and volume of the gas entering the interior are reduced to a certain extent, but also facilitates the subsequent granulation tissue from the tracheal wall to climb over the through hole. Given enough time, the granulation tissue can completely climb over the through hole, thereby isolating it from the external space and ensuring the reduction of the flow rate and volume of the airflow. At the same time, it gradually seals the internal space, allowing the gas in the lung lobe to be slowly discharged, thereby reducing the incidence of pneumothorax.

[0094] It should be noted that the ratio of the total area of ​​the through holes to the outer surface area of ​​the third coating 12 can be any value between 1% and 75%, such as 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, etc. Users can choose and set according to their needs, and no specific limitation is made here. It should be noted that the total area of ​​the through holes is the total area of ​​all through holes, and the outer surface area of ​​the third coating 12 is the total area of ​​the outer surface of the coating (including all through holes).

[0095] It should be further noted that the ratio c of the total area of ​​the through holes to the outer surface area of ​​the third membrane 12 is limited to 1% to 40%, which has the best effect on decelerating and reducing the volume of airflow, achieving a significant therapeutic effect on emphysema, reducing damage to emphysema, and is beneficial for the treatment of emphysema and effectively reducing the incidence of pneumothorax.

[0096] In one embodiment, the frame includes a third skeleton 11 and a third covering 12 covering the inner wall and / or outer wall of the third skeleton 11.

[0097] Preferably, the third membrane 12 is disposed alone on the outer wall of the third frame 11, or disposed alone on the inner wall of the third frame 11, or two membranes are disposed simultaneously on the inner and outer walls of the third frame 11, thereby effectively isolating the inner and outer spaces of the third frame 11 and ensuring the treatment of gas and the therapeutic effect on emphysema.

[0098] More preferably, the third skeleton 11 and the third membrane 12 are connected by processes such as sewing, hot pressing or wrapping, which not only simplifies the process but also achieves a stable connection between the two, resulting in higher overall structural strength.

[0099] In one embodiment, the frame has a main channel inside, the main channel including at least one cavity 4, the cavity 4 having an air inlet 13 and an air outlet 14, the direction from the air inlet 13 to the air outlet 14 is defined as normal C, a first point a and a second point b are arbitrarily selected on the inner wall of the cavity 4 near the air inlet 13, the first point a being between the air inlet 13 and the second point b, a third point c and a fourth point d are arbitrarily selected on the inner wall of the cavity 4 near the air outlet 14, the third point c being between the air outlet 14 and the fourth point d, the angle e between the ray D passing through the second point b with the first point a as the endpoint and the normal C is less than 90°, the angle f between the ray E passing through the third point c with the fourth point d as the endpoint and the normal C satisfies 90°≤f≤180°, and so on. Figure 3 , 5 As shown in Figure -7.

[0100] Preferably, the main channel is the channel for gas flow within the frame, and the main channel mainly serves to slow down and reduce the amount of gas inhaled into the emphysema area.

[0101] More preferably, the main channel is composed of one or more cavities 4. When the main channel includes only one cavity 4, the air inlet 13 of the cavity 4 is the air inlet of the main channel, and the air outlet 14 of the cavity 4 is the air outlet of the main channel. When the main channel includes multiple cavities 4, the multiple cavities 4 are arranged sequentially from the proximal end to the distal end and connected in series. The air outlet of the previous cavity 4 is the air inlet of the next cavity 4, and the air inlet 13 of the cavity 4 closest to the proximal end is the air inlet of the main channel, and the air outlet 14 of the cavity 4 closest to the distal end is the air outlet of the main channel. The arrangement of multiple cavities 4 can make the deceleration and volume reduction effect of the gas inhaled into the emphysema area more ideal.

[0102] Preferably, the normal C is the direction from the air inlet 13 of the cavity 4 to the air outlet 14, which is actually the central axis of the cavity 4 and points towards the air outlet 14. The air inlet 13 at this location is the air inlet during intake, and the air outlet 14 at this location is the air outlet during intake.

[0103] More preferably, both the first point a and the second point b are located close to the air inlet 13, with the first point a positioned between the second point b and the air inlet 13. That is, the first point a is closer to the air inlet 13 than the second point b. The distance between the first point a and the air inlet 13 and the distance between the second point b and the first point a can be selected and set as needed, and no specific limitation is made here.

[0104] Furthermore, both the third point c and the fourth point d are positioned close to the air outlet 14, with the third point c located between the fourth point d and the air outlet 14. In other words, the third point c is closer to the air outlet 14 than the fourth point d. The distance between the third point c and the fourth point d, as well as the distance between the third point c and the air outlet 14, can be selected and set as needed, and no specific limitation is made here.

[0105] Furthermore, the direction of ray D is from the first point a to the second point b. Ray D intersects the normal C, and the angle e between them is less than 90°. Thus, during exhalation, the airflow flows from the distal emphysema area towards the proximal area. The gas in the emphysema area enters from the outlet 14 of cavity 4. When the gas entering cavity 4 flows to the inlet 13, a small portion of the gas touches the area where the first point a and the second point b are located. Since the angle e is an acute angle, the flow rate and velocity of the airflow will not be weakened, allowing the gas in the emphysema area to be expelled quickly.

[0106] The direction of ray E is from the fourth point d to the third point c. Ray E intersects the normal C, and the angle f between them satisfies 90°≤f≤180°. Thus, during inhalation, the gas near the end enters the inner wall of cavity 4 through the air inlet 13, and then flows to the area between the third point c and the fourth point d at the air outlet 14. This has the effect of rebounding and diverting the gas, and some of the gas is diverted to the area away from the air outlet 14. This greatly reduces the gas velocity and flow rate discharged from the air outlet 14 to the emphysema area, preventing the aggravation of emphysema and achieving a long-term effective treatment effect.

[0107] It should be noted that: such as Figure 6 As shown, where the degree measure of f is 90°; as Figure 7 As shown, the degree of f is greater than 90°. It is precisely the above-mentioned limitation of the included angles e and f that ensures that the airflow weakens more during inhalation (airflow from the proximal end to the distal end, i.e., from the inlet 13 to the outlet 14) than during exhalation (airflow from the distal end to the proximal end, i.e., from the outlet 14 to the inlet 13), thus preventing the condition of the emphysema area from worsening and facilitating the rapid expulsion of gas from the emphysema area.

[0108] In one embodiment, the frame is disposed within the fixed frame 2, and the connecting member 3 is provided in two parts, located axially at both ends within the fixed frame 2, such as... Figure 3 As shown.

[0109] Preferably, the frame can be a cylinder or other geometric shapes, and the user can choose to set it according to their needs. No specific limitation is made here.

[0110] More preferably, the frame is set inside the fixed frame 2, and there is a gap between the frame and the fixed frame 2, which not only protects the frame, but also prevents the diameter of the frame from changing with the diameter of the bronchus, so as to reduce the impact on the gas inside the frame.

[0111] It should be noted that the above-mentioned structural limitations allow gas to pass through the treatment unit 1 efficiently, and prevent excessive sputum from remaining on the outside of the treatment unit 1.

[0112] In one embodiment, the fixing frame 2' is at least disposed on one side of the frame body along its axial direction, and the connecting member 3' is located axially between the fixing frame 2' and the frame body, such as... Figure 11 and Figure 12 As shown.

[0113] Preferably, one fixing frame 2' can be provided and located on one side of the frame's axial direction. The fixing frame 2' and the frame are arranged sequentially along the axial direction. In other embodiments, two fixing frames 2' can also be provided and located on opposite sides of the frame's axial direction, such as... Figure 11As shown. The specific number of fixed frames 2' can be set as needed, and no specific limit is made here.

[0114] More preferably, the connector 3' is positioned axially between the fixed frame 2 and the frame body. One end of the connector 3' is fixedly connected to the end of the fixed frame 2' near the frame body, and the other end of the connector 3' is fixedly connected to the end of the frame body near the fixed frame 2', thereby achieving a stable connection between the fixed frame 2' and the frame body.

[0115] It should be noted that when the fixed frame 2' is a cylinder and the frame is a cylinder, the connector 3' is a frustum shape, thereby achieving a stable connection between the fixed frame 2' and the frame.

[0116] In one embodiment, such as Figure 11 As shown, the fixing frame 2 is provided with a plurality of pointed objects 5 for piercing into the bronchial tissue.

[0117] Preferably, in order to securely fix the emphysema treatment device 100 to the inner wall of the bronchus and prevent it from slipping inside the bronchus, a pointed body 5 can be provided on the outer surface of the fixing frame 2. The pointed body 5 can then penetrate into the tissue of the inner wall of the bronchus to securely fix the emphysema treatment device inside the bronchus, thereby effectively extending its service life.

[0118] More preferably, the area of ​​the end of the pointed body 5 away from the fixed frame 2 is smaller than the area of ​​the pointed body 5 near the fixed frame 2. For example, the vertebral body or the end away from the fixed frame 2 is designed with rounded corners, which is conducive to penetrating into the tissue and reducing damage to the bronchus.

[0119] Preferably, the pointed body 5 is fixed to the outer surface of the fixing frame 2. It can be fixed by adhesive bonding or by integral molding or other fixed connection methods. The specific connection method can be set as needed and is not specifically limited here.

[0120] More preferably, the pointed body 5 can be disposed on the first skeleton 21 of the fixing frame 2, or on the first covering membrane 22, or simultaneously on both the first skeleton 21 and the first covering membrane 22, thereby satisfying the requirement of fixing it to the fixing frame 2 and inserting it into the tissue. When the pointed body 5 is disposed on the first skeleton 21, the material of the pointed body 5 is preferably the same as the material of the first skeleton 21; when the pointed body 5 is disposed on the first covering membrane 22, the material of the pointed body 5 is preferably the same as the material of the first covering membrane 22.

[0121] Furthermore, the number of pointed bodies 5 can be set to multiple, and the multiple pointed bodies 5 can be arranged at equal intervals, such as circumferentially or axially, so as to achieve uniform force distribution and extend service life. They can also be distributed in a dispersed manner, etc., without specific limitations.

[0122] In one embodiment, such as Figure 9 and Figure 10 As shown, there are multiple treatment components 1, and the connector 3 is fixedly connected to the frame of the multiple treatment components 1, and seals the gap between the treatment component 1 and the fixed frame 2.

[0123] Preferably, one or more treatment components 1 can be provided. In this embodiment, three treatment components 1 are provided and arranged circumferentially at equal intervals. The provision of multiple treatment components 1 can realize multiple deceleration and volume reduction of gas, and even if one of them is damaged, the other two can still be used, extending their service life and ensuring long-term effective treatment of emphysema.

[0124] More preferably, the connector 3 is located between the treatment component 1 and the fixing frame 2, and between the treatment components 1 and the treatment components 1. The connector 3 can not only achieve a stable connection between the treatment component 1 and the fixing frame 2, but also seal the gap between the two to prevent gas from passing through the middle of the two.

[0125] In one embodiment, such as Figure 13 and Figure 14 As shown, the fixed frame 2” is a spiral-shaped support that surrounds the treatment component 1. The connector 3” is located between the fixed frame 2” and the treatment component 1. One end of the connector 3” is fixedly connected to the fixed frame 2”, and the other end of the connector 3” is fixedly connected to the frame of the treatment component 1. The connector 3” seals the gap between the fixed frame 2” and the frame.

[0126] Preferably, the fixed frame 2” is a spiral bracket, which can not only reduce costs but also simplify the structure, resulting in lower costs and making it suitable for widespread application.

[0127] More preferably, the fixing frame 2” is made of a biocompatible material, such as nickel-titanium alloy, stainless steel or cobalt-nobel alloy, etc. The specific material selection can be set as needed and is not specifically limited here.

[0128] Preferably, the connector 3” is located between the fixed frame 2” and the frame body. It can not only seal the gap between the two to prevent gas from flowing out from the gap, but also play a role in firmly connecting the two, making the overall structure more stable and significantly improving the treatment effect on emphysema.

[0129] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A device for treating emphysema, characterized in that, The treatment includes a treatment component (1), a fixing frame (2), and a connector (3) connecting the treatment component (1) and the fixing frame (2). The treatment component (1) includes a frame body, and the connector (3) is disposed between the fixing frame (2) and the frame body. The connector (3) seals the gap between the fixing frame (2) and the frame body.

2. The emphysema treatment device according to claim 1, characterized in that, The fixing frame (2) is cylindrical, and the diameter of the fixing frame (2) is larger than the diameter of the frame body; and / or, the fixing frame (2) is provided with a plurality of pointed objects (5) for piercing into the bronchial tissue.

3. The emphysema treatment device according to claim 1, characterized in that, The fixed frame (2) includes a first skeleton (21).

4. The emphysema treatment device according to claim 3, characterized in that, The fixed frame (2) further includes a first covering film (22) fixed to the inner wall and / or outer wall of the first skeleton (21).

5. The emphysema treatment device according to claim 1, characterized in that, The connector (3) includes a second film (32), one end of which is fixedly connected to the fixed frame (2), and the other end of which is fixedly connected to the frame. And / or, the connector (3) includes a second frame (31), one end of which is fixedly connected to the fixed frame (2), and the other end of which is fixedly connected to the frame.

6. The emphysema treatment device according to claim 5, characterized in that, The second membrane (32) is fixed to the inner and / or outer wall of the second skeleton (31).

7. The emphysema treatment device according to claim 1, characterized in that, The frame includes a third skeleton (11), the third skeleton (11) is provided with a plurality of mesh holes (15), the area of ​​the mesh holes (15) is S1, the outer surface area of ​​the third skeleton (11) is S2, wherein 1% ≤ S1 / S2 ≤ 75%; Alternatively, the frame may include a third covering (12); Alternatively, the frame may include a third skeleton (11) and a third covering (12) covering the inner and / or outer walls of the third skeleton (11).

8. The emphysema treatment device according to claim 7, characterized in that, The frame has a main channel inside, which includes at least one cavity (4). The cavity (4) has an air inlet (13) and an air outlet (14). The direction from the air inlet (13) to the air outlet (14) is defined as the normal. Arbitrarily select a first point (a) and a second point (b) on the inner wall of the cavity (4) near the air inlet (13). The first point (a) is located between the air inlet (13) and the second point (b). 4) Take any third point (c) and fourth point (d) on the inner wall near the air outlet (14). The third point (c) is located between the air outlet (14) and the fourth point (d). The angle e between the ray passing through the second point (b) with the first point (a) as the endpoint and the normal is less than 90°. The angle f between the ray passing through the third point (c) with the fourth point (d) as the endpoint and the normal satisfies 90°≤f≤180°.

9. The emphysema treatment device according to any one of claims 1 to 8, characterized in that, The frame is disposed within the fixed frame (2), and the connector (3) has two parts located at both ends within the fixed frame (2) in the axial direction.

10. The emphysema treatment device according to any one of claims 1 to 8, characterized in that, The fixing frame (2) is at least located on one side of the frame body along its axial direction, and the connector (3) is located between the fixing frame (2) and the frame body in the axial direction.

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