Emphysema treatment device

Abstract

The emphysema treatment device comprises a fixed part, a first end part and a second end part respectively located at the proximal end and the distal end of the fixed part. The first end part, the fixed part and the second end part enclose a cavity. The proximal end of the first end part is provided with an air inlet, and the distal end of the second end part is provided with an air outlet. The maximum outer diameter of the first end part is smaller than the outer diameter of the fixed part, and the maximum outer diameter of the second end part is smaller than the outer diameter of the fixed part. The maximum outer diameter of the first end part and the maximum outer diameter of the second end part are both smaller than the outer diameter of the fixed part, so that a gap exists between the first end part and the second end part and the inner wall of the bronchus after the device is implanted in the bronchus, thereby providing space for granulation proliferation and preventing the granulation from extending into the cavity and affecting the circulation of gas.

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] With the improvement of people's living standards and changes in dietary structure, various diseases are gradually increasing, including lung diseases such as emphysema.

[0003] Emphysema is a common disease, especially among the elderly. Statistics show that the five-year survival rate of patients with end-stage emphysema is less than 50%. How to achieve effective treatment for emphysema has become an urgent technical problem to be solved.

[0004] Traditional treatments for emphysema include medical and surgical approaches. Medical treatments mainly include oxygen therapy, prevention of lung infections, and bronchodilators, but their effectiveness is extremely limited. Surgical treatments primarily focus on lung volume reduction, but they also have many limitations, such as strict surgical indications, numerous complications, anesthesia and anesthesia-related complications, and unpredictable efficacy. Postoperative complications are irreversible, increasing patient suffering and stress, resulting in unsatisfactory treatment outcomes.

[0005] To better treat emphysema, improve patients' quality of life, and reduce surgical trauma, devices can be implanted into the bronchus to achieve therapeutic effects by affecting gas flow, such as a one-way valve. These devices typically have an inner lumen; after implantation, their outer surface rests against the bronchial wall, maintaining the bronchus's normal shape. However, with prolonged use, granulation tissue can grow on the bronchial wall and extend into the device's lumen, affecting air intake and exhalation, thus impacting treatment effectiveness and increasing patient discomfort. Summary of the Invention

[0006] In order to overcome the above-mentioned technical problems, the present invention provides a pulmonary emphysema treatment device that can solve the above-mentioned technical problems.

[0007] As conceived above, one technical solution adopted by the present invention is: a pulmonary emphysema treatment device, comprising a fixing part, a first end and a second end respectively disposed at the proximal end and the distal end of the fixing part, the first end, the fixing part and the second end forming a cavity, the proximal end of the first end being provided with an air inlet communicating with the cavity, the distal end of the second end being provided with an air outlet communicating with the cavity, the maximum outer diameter of the first end being smaller than the outer diameter of the fixing part, and the maximum outer diameter of the second end being smaller than the outer diameter of the fixing part.

[0008] The emphysema treatment device provided in this application has a first end portion located proximal to the fixation part and a second end portion located distal to the fixation part. The maximum outer diameters of both the first and second end portions are smaller than the outer diameter of the fixation part. When the device is implanted into the bronchus, gaps exist between the first end portion and the bronchial wall, and between the second end portion and the bronchial wall. After prolonged use, newly grown granulation tissue will spread within these gaps and not extend into the device's cavity, thus preventing obstruction of gas flow and ensuring the therapeutic effect of emphysema treatment. Attached Figure Description

[0009] Figure 1 This is a perspective view of one embodiment of the emphysema treatment device of the present invention;

[0010] Figure 2 yes Figure 1 The image shown is a perspective view of the emphysema treatment device of the present invention from another angle.

[0011] Figure 3 yes Figure 2 The image shown is a front view of the emphysema treatment device of the present invention.

[0012] Figure 4 yes Figure 3 The image shown is a bottom view of the emphysema treatment device of the present invention.

[0013] Figure 5 yes Figure 4 The image shows a cross-sectional view of the emphysema treatment device of the present invention along line AA.

[0014] Figure 6 yes Figure 5 The diagram shown illustrates the inhalation state of the emphysema treatment device of the present invention.

[0015] Figure 7 yes Figure 5 The diagram shows the expiratory state of the emphysema treatment device of the present invention.

[0016] Figure 8 This is a schematic diagram of the emphysema treatment device of the present invention after it has been implanted into the bronchus.

[0017] Explanation of reference numerals in the attached diagram: 100-Emphysema treatment device; 1-Fixing part; 2-First end; 21-Proximal end; 22-Distal end; 3-Second end; 31-Distal end; 32-Proximal end; 33-Arc-shaped surface; 4-Isolation part; 5-Air inlet; 6-Air outlet; 7-Cavity; 8-First constriction; 9-Second constriction; 10-Channel; a-First point; b-Second point; c-Third point; d-Fourth point; E-Ending surface; F-Normal line; G-Ray; H-Ray; e-Angle; f-Angle; 200-Emphysema region; 300-Bronchi. Detailed Implementation

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] A specific embodiment of this application provides an emphysema treatment device 100, including a fixation part 1, a first end portion 2 disposed at the proximal end of the fixation part 1, and a second end portion 3 disposed at the distal end of the fixation part 1, such as... Figures 1 to 3 , Figure 8 As shown. The first end portion 2, the second end portion 3, and the fixing portion 1 are coaxially arranged. In other embodiments, the first end portion 2, the second end portion 3, and the fixing portion 1 may be non-coaxial.

[0025] Preferably, when the emphysema treatment device 100 is implanted into the bronchus 300, the outer surface of the fixing part 1 can abut against the inner wall of the bronchus 300 to fix the emphysema treatment device 100 within the bronchus 300. In other embodiments, the outer surface of the fixing part 1 may not abut against the inner wall of the bronchus 300, as long as it can be fixed within the bronchus 300. For example, a pointed object can be provided on the outer peripheral surface of the fixing part 1 to penetrate the inner wall of the bronchus 300 to achieve the effect of fixing the device. This is not specifically limited here. It should be noted that the diameter of the outer surface of the fixing part 1 can be larger than the diameter of the inner wall of the bronchus 300, so that the fixing part 1 and the bronchus 300 have an interference fit, resulting in a more ideal stabilizing effect. In other embodiments, the diameter of the outer surface of the fixing part 1 can also be equal to or smaller than the diameter of the inner wall of the bronchus 300 for implantation into the bronchus 300. This is not specifically limited here.

[0026] More preferably, the fixing part 1 can be a cylinder, that is, a constant outer diameter, or other geometric shapes, etc. The user can set it according to needs, and no specific limitation is made here.

[0027] Preferably, the first end portion 2 is disposed near the end of the fixing portion 1, and the first end portion 2 is fixedly connected to the fixing portion 1, such as by bonding. In this embodiment, the first end portion 2 and the fixing portion 1 are integrally formed, which can simplify the process and improve the structural stability.

[0028] Furthermore, the second end portion 3 is located at the far end of the fixing portion 1, and the second end portion 3 is fixedly connected to the fixing portion 1, such as by bonding. In this embodiment, the second end portion 3 and the fixing portion 1 are integrally formed, which can simplify the process and improve the structural stability.

[0029] Furthermore, the shapes of the first end 2 and the second end 3 can be set as needed, such as cones, cylinders, etc., without specific limitations here.

[0030] It should be noted that the "proximal end" mentioned above refers to the end closer to the operator, and the "distal end" refers to the end farther away from the operator.

[0031] It should be further noted that the fixing part 1, the first end 2 and the second end 3 are made of materials with good biocompatibility and elasticity, such as silicone, silicone rubber, silk fibroin, polytetrafluoroethylene, etc., and can be composed of one or more of the above materials, etc., without specific limitations.

[0032] In one embodiment, the outer diameter of the second end portion 3 varies continuously in the direction from the proximal end to the distal end, such as... Figures 1 to 7 As shown.

[0033] Preferably, such as Figure 5As shown, the proximal end is above, the distal end is below, and the direction from the proximal end to the distal end is the direction from above to below.

[0034] More preferably, the outer diameter of the second end portion 3 is the diameter of the outer circumferential surface of the second end portion 3.

[0035] More preferably, in the direction from the proximal end to the distal end, the change in the outer diameter of the second end 3 is continuous, such as decreasing, or decreasing first and then increasing, or increasing first and then decreasing, etc.

[0036] It should be noted that when the outer diameter of the second end 3 first decreases and then increases, the outer diameter of the distal end of the second end 3 is smaller than that of its proximal end, which reduces the difficulty of implantation and facilitates implantation into the bronchus. Furthermore, when the outer diameter of the second end 3 first increases and then decreases, the outer diameter of the distal end of the second end 3 is smaller than that of its proximal end, and the axial length of the increasing portion of the proximal outer diameter of the second end 3 is smaller, thereby avoiding the formation of a large indentation that could cause the implantation to be stuck, thus reducing the difficulty of implantation.

[0037] It should also be noted that by continuously changing the outer diameter of the second end 3, it can be successfully implanted into the bronchus 300, reducing the difficulty of the operation for doctors during surgery.

[0038] In one embodiment, the first end portion 2, the fixing portion 1, and the second end portion 3 enclose a cavity 7. The proximal end 21 of the first end portion 2 is provided with an air inlet 5 communicating with the cavity 7, and the distal end 31 of the second end portion 3 is provided with an air outlet 6 communicating with the cavity 7. Figures 1 to 7 As shown.

[0039] Preferably, the cavity 7 is used to completely or partially obstruct the gas entering its interior, so that the gas cannot enter the emphysema region 200 or the amount of gas entering the emphysema region 200 is reduced, thereby achieving the purpose of treating the emphysema region 200.

[0040] More preferably, the first end 2 is provided with an air inlet 5, which is connected to the cavity 7, so that when inhaling, gas enters the cavity 7 through the air inlet 5, and when exhaling, the gas in the cavity 7 can be discharged from the air inlet 5, so as to meet the needs of inhalation and exhalation and realize the flow of gas.

[0041] More preferably, the shape of the air intake 5 can be circular, elliptical, or polygonal, etc. The specific shape of the air intake 5 is not specifically limited here.

[0042] More preferably, the distal end 31 of the second end 3 is disposed away from the fixing part 1, and the second end 3 is provided with an air outlet 6, which is connected to the cavity 7. This allows the gas in the cavity 7 to be discharged from the air outlet 6 into the emphysema region 200 during inhalation and to enter the cavity 7 through the air outlet 6 during exhalation, thus realizing gas circulation.

[0043] Furthermore, the shape of the air outlet 6 can be circular, elliptical, or polygonal, etc. The specific shape of the air outlet 6 is not specifically limited here.

[0044] In one embodiment, the maximum outer diameter of the first end portion 2 is smaller than the outer diameter of the fixing portion 1, so that after the device is implanted into the bronchus, there is a gap between the outer peripheral surface of the first end portion 2 and the inner wall of the bronchus. Similarly, the maximum outer diameter of the second end portion 3 is smaller than the outer diameter of the fixing portion 1, so that after the device is implanted into the bronchus, there is a gap between the outer peripheral surface of the second end portion 3 and the inner wall of the bronchus. Figures 1 to 7 As shown.

[0045] Preferably, the maximum outer diameter of the first end 2 is the maximum value of the outer circumferential diameter of the first end 2, that is, the diameter at any position of the outer circumferential surface of the first end 2 is less than the maximum value, thereby limiting the outer diameter of the first end 2 to a specific range and preventing its excessive diameter from affecting the use effect.

[0046] More preferably, when the fixing part 1 is a cylinder, the outer diameter of the fixing part 1 is the diameter of its outer circumferential surface; when the fixing part 1 is other geometric shapes, the outer diameter of the fixing part 1 is the maximum diameter of its outer circumferential surface.

[0047] Preferably, the maximum outer diameter of the first end 2 is smaller than the outer diameter of the fixing part 1, so that after the instrument is implanted into the bronchus, there is a gap between the outer peripheral surface of the first end 2 and the inner wall of the bronchus, which can accommodate newly grown granulation tissue, providing a space for granulation tissue to spread, thereby preventing granulation tissue from growing into the cavity 7 and affecting the flow of gas.

[0048] Preferably, the maximum outer diameter of the second end 3 is the maximum value of the outer circumferential diameter of the second end 3, that is, the diameter at any position of the outer circumferential surface of the second end 3 is less than the maximum value, thereby limiting the outer diameter of the second end 3 to a specific range and preventing its diameter from being too large and affecting the use effect.

[0049] More preferably, the maximum outer diameter of the second end 3 is smaller than the outer diameter of the fixing part 1, so that after the instrument is implanted into the bronchus, there is a gap between the outer peripheral surface of the second end 3 and the inner wall of the bronchus 300, which can be used to accommodate newly grown granulation tissue, provide a space for granulation tissue to crawl over, and prevent granulation tissue from growing into the cavity 7 and affecting the flow of gas.

[0050] In one embodiment, the cavity 7 has a first constriction 8 and a second constriction 9, the first constriction 8 communicating with the air inlet 5, and the second constriction 9 communicating with the air outlet 6, the second constriction 9 having an end surface E, such as... Figure 5 As shown.

[0051] Preferably, the first constriction 8 is used to communicate with the air inlet 5, so that when air is drawn in, the gas enters from the air inlet 5 into the first constriction 8 and then enters the cavity 7, thereby achieving the purpose of connecting the air inlet 5 and the cavity 7.

[0052] More preferably, the second constriction 9 is used to communicate with the air outlet 6, and the two are connected by a channel 10, so that when inhaling, the gas enters the emphysema region 200 from the second constriction 9, realizing the communication between the cavity 7 and the air outlet 6.

[0053] More preferably, the second constriction 9 has an ending surface E perpendicular to the airflow direction. For ease of understanding, in Figure 5 In the middle, the emphysema treatment device 100 is placed vertically. Therefore, the airflow direction is vertically downward, and the ending surface E is perpendicular to the vertical direction, which is the horizontal direction.

[0054] It should be noted that the "first narrowing" refers to the proximal end of the cavity 7, and the "second narrowing" refers to the proximal end of the channel 10. The diameters of both narrowings are smaller than the diameters of other parts of the cavity 7 in the direction perpendicular to the normal F.

[0055] In one embodiment, a first point a and a second point b are arbitrarily selected on the inner wall of the cavity 7 near the first constriction 8, with the first point a located between the first constriction 8 and the second point b. Similarly, a third point c and a fourth point d are arbitrarily selected on the inner wall of the cavity 7 near the second constriction 9, with the third point c located between the second constriction 9 and the fourth point d. Figure 5 As shown.

[0056] Preferably, both the first point a and the second point b are located close to the first narrowing 8, and the first point a is closer to the first narrowing 8 than the second point b. The first point a is located between the first narrowing 8 and the second point b. The distance between the first point a and the first narrowing 8 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.

[0057] More preferably, both the third point c and the fourth point d are close to the second narrowing 9, and the third point c is closer to the second narrowing 9 than the fourth point d, so that the third point c is located between the second narrowing 9 and the fourth point d. The distance between the third point c and the second narrowing 9 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.

[0058] In one embodiment, a ray perpendicular to the ending surface E and extending distally is defined as the normal F. The angle e between the ray G (with the first point a as its endpoint and passing through the second point b) and the normal F is less than 90°. The angle f between the ray H (with the fourth point d as its endpoint and passing through the third point c) and the normal F satisfies 90° ≤ f ≤ 180°. Figure 5 As shown.

[0059] Preferably, the normal F is perpendicular to the end surface E, and the normal F points from the air inlet 5 to the air outlet 6, which is actually the direction of gas flow in the emphysema treatment device 100 during inhalation.

[0060] More preferably, ray G has a first point a as its endpoint and passes through the second point b, with its direction pointing from the first point a to the second point b. Ray G intersects the normal F, and the angle e between the two is less than 90°. Thus, when exhaling, as the airflow moves from the distal end to the proximal end, the gas entering the cavity 7 flows to the first constriction 8, and most 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 volume of the airflow are not significantly reduced.

[0061] Preferably, the ray H has the fourth point d as its endpoint and passes through the third point c, with its direction pointing from the fourth point d to the third point c. The ray H intersects the normal F, and the angle f between the two satisfies 90°≤f≤180°. Thus, when inhalation, the gas entering the cavity 7 is bounced and diverted when it flows to the second constriction 9, and part of it is diverted to the area away from the second constriction 9. This greatly reduces the flow rate and volume of the gas discharged from the second constriction 9, preventing the aggravation of the emphysema area 200 and achieving a long-term and effective therapeutic effect.

[0062] In summary, by limiting the included angles e and f as described above, the airflow weakens more during inhalation (airflow from proximal to distal) than during exhalation (airflow from distal to proximal), thus preventing the emphysema region 200 from worsening and rapidly expelling the gas within the emphysema region 200.

[0063] In one embodiment, the outer diameter of the first end portion 2 increases in the direction from the proximal end to the distal end, such as... Figures 1 to 7 As shown.

[0064] Preferably, the outer diameter of the first end 2 gradually increases from the proximal end to the distal end, that is, the first end 2 is tapered. This not only simplifies the process and facilitates manufacturing, but also reduces the diameter of the air inlet 5, thereby reducing the flow rate and velocity of the gas entering the cavity 7. At the same time, it facilitates the gripping forceps to clamp the first end 2 to implant the emphysema treatment device 100 into the bronchus 300 or remove the emphysema treatment device 100.

[0065] It should be noted that in other embodiments, the first end 2 can also be other geometric shapes, such as a wave tube, etc., which are not specifically limited here.

[0066] In one embodiment, the outer diameter of the second end portion 3 decreases in the direction from the proximal end to the distal end, such as... Figures 1 to 7 As shown.

[0067] Preferably, the outer diameter of the second end 3 gradually decreases from the proximal end to the distal end, that is, the second end 3 is tapered. This not only simplifies the process and facilitates manufacturing, but also reduces the diameter of the air outlet 6, thereby reducing the flow rate and velocity of the gas entering the cavity 7 and enhancing the therapeutic effect on the emphysema region 200.

[0068] In one embodiment, the emphysema treatment device 100 may further include an isolation portion 4 disposed at the proximal and / or distal end of the fixing portion 1, the isolation portion 4 being connected to the fixing portion 1 and sleeved outside the first end portion 2 and / or the second end portion 3, such as... Figures 1 to 7 As shown.

[0069] Preferably, the outer surface of the isolation part 4 is used to abut against the inner wall of the bronchus 300, thereby enhancing the fixation to the inner wall of the bronchus 300 and improving structural stability.

[0070] More preferably, the isolation part 4 and the fixing part 1 are fixedly connected, and the two can be fixedly connected by means of bonding or other methods. In this embodiment, the isolation part 4 and the fixing part 1 are integrally formed, which not only simplifies the process but also improves the structural stability.

[0071] Preferably, the isolation part 4 is located radially outside the first end 2, so that there is a gap between the first end 2 and the isolation part 4. This not only allows the isolation part 4 to abut against the inner wall of the bronchus 300 to enhance the fixation effect, but also allows granulation tissue to crawl over the gap between the isolation part 4 and the first end 2 and / or the second end 3, thereby effectively preventing granulation tissue from crawling over the first end 2 and / or the second end 3 and entering the cavity 7.

[0072] In one embodiment, the outer diameter of any portion of the first end 2 is D1, and the outer diameter of the fixing part 1 is D2, wherein 30% ≤ D1 / D2 ≤ 90%, such as... Figure 3 As shown.

[0073] Preferably, the outer diameter D1 of any part of the first end 2 is the outer diameter of any position on the outer circumferential surface of the first end 2. In this embodiment, the minimum outer diameter of the first end 2 is the outer diameter of its proximal end face, and the maximum outer diameter of the first end 2 is the outer diameter of the part where its distal end connects with the fixing part 1.

[0074] In one embodiment, the outer diameter D2 of the fixing part 1 is the diameter of the outer peripheral surface of the bronchus 300 that abuts against the inner wall of the bronchus 300.

[0075] More preferably, the ratio of D1 / D2 is any value between 30% and 90%, such as 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, etc. The specific value can be set as needed and is not specifically limited here. The above-mentioned ratio range not only prevents the outer diameter of the first end 2 from being too small, resulting in too little gas entering the cavity 7, but also prevents the outer diameter of the first end 2 from being too large, resulting in too much gas entering the cavity 7 and too small a gap between it and the inner wall of the bronchus 300, causing granulation tissue to extend into the cavity 7, thus ensuring the therapeutic and fixation effects on emphysema.

[0076] It should be noted that the D1 / D2 ratio is preferably between 40% and 60%, which makes the flow rate and velocity of the gas entering the emphysema region 200 more suitable.

[0077] Preferably, the proximal end of the first end 2 is provided with a rounded corner, the radius of which is any value between 0.2mm and 0.4mm, such as 0.2mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm, 0.29mm, 0.3mm, 0.35mm, 0.4mm, etc. The specific value can be set as needed and is not specifically limited here.

[0078] It should be noted that the proximal end of the first end 2 is rounded to facilitate gripping with the capture pincers and to prevent scratching or puncturing the inner wall of the bronchus 300 during the removal process, thus ensuring its safe use.

[0079] More preferably, the radius of the rounded corner of the proximal end of the first end 2 is any value between 0.25 mm and 0.3 mm, thereby simplifying the manufacturing process and improving safety.

[0080] In one embodiment, the wall thickness w1 of the first end portion 2 is greater than the wall thickness w2 of the isolation portion 4, such as... Figure 7 As shown.

[0081] Preferably, the wall thickness w1 of the first end 2 is the thickness between the inner wall and the outer wall of the first end 2. The wall thickness of the first end 2 can be uniform, that is, the wall thickness at any position is the same. The wall thickness of the first end 2 can also be non-uniform, that is, the wall thickness at different positions is different.

[0082] More preferably, the wall thickness w2 of the isolation part 4 is the thickness between the inner and outer surfaces of the isolation part 4. The wall thickness of the isolation part 4 can be uniform, that is, the wall thickness is the same at any position. The wall thickness of the isolation part 4 can also be non-uniform, that is, the wall thickness is different at different positions.

[0083] It should be noted that the wall thickness w1 of the first end 2 is the wall thickness at any position of the first end 2, and the wall thickness w2 of the isolation part 4 is the wall thickness at any position of the isolation part 4.

[0084] Preferably, the wall thickness w1 of the first end 2 is greater than the wall thickness w2 of the isolation part 4, thereby ensuring the structural strength of the first end 2, allowing gas to pass through the air inlet 5 into the cavity 7, preventing deformation that would affect gas flow, and the wall thickness of the isolation part 4 is less than the wall thickness of the first end 2, thereby reserving a larger gap between the isolation part 4 and the first end 2 to accommodate more granulation tissue.

[0085] More preferably, the wall thickness w1 of the first end 2 is any value between 0.3mm and 1.1mm, such as 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.1mm, etc. The specific value can be set as needed and is not specifically limited here.

[0086] It should be noted that the wall thickness w1 of the first end 2 is preferably any value between 0.4 mm and 1 mm to maximize its effectiveness.

[0087] Furthermore, the wall thickness w2 of the isolation part 4 can be any value between 0.2mm and 1mm, such as 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, etc.

[0088] It should be noted that the wall thickness w2 of the isolation section 4 is preferably any value between 0.3mm and 0.6mm to maximize its effectiveness.

[0089] In one embodiment, the hardness of the first end portion 2 is greater than the hardness of the insulating portion 4, such as... Figures 1 to 7 As shown.

[0090] Preferably, the hardness of the isolation part 4 is any value between 20A and 35A, such as 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 31A, 32A, 33A, 34A, 35A, etc. The specific value can be set as needed and is not specifically limited here.

[0091] It should be noted that the hardness range of the isolation part 4 is preferably any value between 20A and 30A, so as to optimally meet its hardness requirements, thereby not only enhancing the fixation effect by abutting against the inner wall of the bronchus 300, but also preventing scratches on the inner wall of the bronchus 300 and ensuring safe use.

[0092] More preferably, the hardness range of the first end 2 is greater than 20A and less than 60A, such as 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 28A, 29A, 30A, 40A, 50A, 59A, etc. The specific value can be set as needed and is not specifically limited here.

[0093] It should be noted that the hardness range of the first end 2 is preferably greater than or equal to 50A and less than 60A, so as to optimally meet its hardness requirements, thereby preventing the first end 2 from deforming during breathing and affecting the air intake and exhaust volume, and providing support for the cavity 7 and the air inlet 5.

[0094] In one embodiment, in the direction from the proximal end to the distal end, the length L1 of the first end portion 2 is greater than the length L2 of the isolation portion 4, such as... Figure 6 As shown.

[0095] Preferably, the length L1 of the first end 2 is any value between 2.5mm and 3.5mm, such as 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, etc. The specific value can be set as needed and is not specifically limited here.

[0096] It should be noted that: if the length of the first end 2 is too long, the weight of the first end 2 will be too large, which will affect its stability in the bronchus 300. If the length of the first end 2 is too short, the gap between it and the inner wall of the bronchus 300 will be too small, which will allow granulation tissue to extend into the cavity 7, affecting the flow of gas, and making it impossible for the grasping forceps to firmly grasp it, thus affecting its implantation or removal, and leading to surgical failure.

[0097] More preferably, the length L2 of the isolation portion 4 is any value between 0.8 mm and 1.2 mm, such as 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, etc.

[0098] It should be noted that if the length of the isolation section 4 is too long, it will be close to the proximal end of the first end 2. As a result, after the granulation tissue crawls over the proximal end of the isolation section 4, it can crawl over the proximal end of the first end 2 more quickly and extend into the cavity 7, affecting the flow of gas. If the length of the isolation section 4 is too short, it will affect the stability of the isolation section 4 fixed in the bronchus 300 and reduce the gap between the isolation section 4 and the first end 2, so that the granulation tissue can directly crawl over the proximal end of the first end 2 and extend into the cavity 7.

[0099] More preferably, the length L1 of the first end 2 is any value between 3 mm and 3.5 mm to achieve the best effect; further, the length L2 of the isolation part 4 is any value between 0.8 mm and 1 mm to achieve the best effect.

[0100] In one embodiment, the hardness of the first end portion 2 is less than the hardness of the fixing portion 1, such as... Figures 1 to 7 As shown.

[0101] Preferably, the hardness range of the first end 2 refers to the above description of the hardness range of the first end 2, and will not be repeated here.

[0102] More preferably, the hardness range of the fixing part 1 is any value between 40A and 60A, such as 40A, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 50A, 55A, 60A, etc. The specific value can be set as needed and is not specifically limited here.

[0103] It should be noted that the hardness range of the fixing part 1 is preferably greater than 50A and less than or equal to 60A, so as to achieve the optimal hardness requirement and make it securely fixed in the bronchus 300.

[0104] Preferably, the hardness of the first end 2 is less than that of the fixing part 1, thereby weakening the radial support force of the first end 2 on the inner wall of the bronchus 300, preventing granulation tissue from forming between the two, and thus extending the service life of the emphysema treatment device 100.

[0105] In one embodiment, the hardness of the proximal end 21 of the first end 2 is less than the hardness of the distal end 22 of the first end 2, such as... Figures 1 to 7 As shown.

[0106] Preferably, the hardness of the proximal end 21 of the first end 2 is greater than 20A and less than or equal to 35A, for example, it can be 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, etc.

[0107] It should be noted that the hardness range of the proximal end 21 of the first end 2 is preferably greater than 20A and less than or equal to 30A to achieve the optimal effect.

[0108] More preferably, the hardness range of the distal end 22 of the first end 2 is greater than or equal to 40A and less than 60A, such as 40A, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 50A, 55A, 59A, etc. The specific value range can be set as needed and is not specifically limited here.

[0109] It should be noted that the hardness range of the distal end 22 of the first end 2 is preferably greater than or equal to 50A and less than 60A, so as to achieve the optimal effect.

[0110] Preferably, the hardness of the proximal end 21 of the first end 2 is less than that of the distal end 22 of the first end 2, thereby making the proximal end 21 easier to deform so that the grasping forceps can be more easily implanted into the interior of the first end 2, so as to more firmly grasp the first end 2 to implant or remove the emphysema treatment device 100 into or from the bronchus 300, and the softer material has a higher coefficient of friction on its outer surface, making it less likely to fall off the grasping forceps.

[0111] In one embodiment, the roughness of the outer surface of the first end portion 2 is greater than the roughness of the isolation portion 4, such as... Figures 1 to 7 As shown.

[0112] Preferably, the roughness of the outer surface of the first end 2 is in the range of 5um to 10um, such as 5um, 6um, 7um, 8um, 9um, 10um, etc. The specific value can be set as needed and is not specifically limited here.

[0113] It should be noted that the roughness range of the outer surface of the first end 2 is preferably 8 μm to 10 μm, so as to achieve the best effect.

[0114] More preferably, the roughness of the isolation portion 4 is the roughness of its outer surface, and is any value between 2um and 7um, such as 2um, 2.1um, 2.2um, 2.3um, 2.4um, 2.5um, 2.6um, 2.7um, 2.8um, 2.9um, 3um, 4um, 5um, 6um, 7um, etc.

[0115] It should be noted that the roughness of the isolation part 4 is preferably in the range of 2µm to 6µm to achieve the best effect.

[0116] Preferably, the roughness of the outer surface of the first end 2 is greater than the roughness of the isolation part 4, so that when the emphysema treatment device 100 is implanted or removed, the grasping forceps can more firmly grasp the outer surface of the first end 2, prevent it from falling off, and ensure the smooth progress of the operation.

[0117] In one embodiment, the roughness of the outer surface of the first end portion 2 is greater than the roughness of the fixing portion 1, such as... Figures 1 to 7 As shown.

[0118] Preferably, the roughness range of the outer surface of the first end 2 is as described above and will not be repeated here.

[0119] More preferably, the roughness of the fixing part 1 is the roughness of the outer surface of the fixing part 1, and is any value between 2um and 9um, such as 2um, 2.1um, 2.2um, 2.3um, 2.4um, 2.5um, 2.6um, 2.7um, 2.8um, 2.9um, 3um, 4um, 5um, 6um, 7um, 8um, 9um, etc. The specific value can be set as needed, and is not specifically limited here.

[0120] It should be noted that the roughness of the fixing part 1 is preferably in the range of 5 μm to 9 μm, so as to achieve the best effect.

[0121] Preferably, the roughness of the outer surface of the first end 2 is greater than the roughness of the fixing part 1, so that when the emphysema treatment device 100 is implanted or removed, the grasping forceps can more firmly grasp the outer surface of the first end 2, prevent it from falling off, and ensure the smooth progress of the operation.

[0122] In one embodiment, the hardness of the outer wall of the first end 2 is less than the hardness of the inner wall of the first end 2, such as... Figures 1 to 7 As shown.

[0123] Preferably, the hardness of the outer wall of the first end 2 is greater than 20A and less than or equal to 35A, such as 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 31A, 32A, 33A, 34A, 35A, etc. The specific value can be set as needed, and will not be elaborated here.

[0124] It should be noted that the hardness range of the outer wall of the first end 2 is preferably greater than 20A and less than or equal to 30A in order to achieve the best effect.

[0125] More preferably, the hardness of the inner wall of the first end 2 is greater than or equal to 40A and less than 60A, for example, it can be 40A, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 50A, 55A, 59A, etc. The specific value can be set as needed and is not specifically limited here.

[0126] It should be noted that the hardness of the inner wall of the first end 2 is preferably greater than or equal to 50A and less than 60A in order to achieve the best effect.

[0127] Preferably, the hardness of the outer wall of the first end 2 is less than that of the inner wall of the first end 2, so that the outer wall of the first end 2 is easier to deform, the capture pincers are easier to embed into the deformation, the locking is tighter, and the softer material has a higher coefficient of friction, making it less likely for the outer wall of the first end 2 to fall off the capture pincers.

[0128] In one embodiment, the outer wall of the first end portion 2 is provided with a plurality of protrusions (not shown).

[0129] Preferably, the protrusions are provided in multiple quantities and distributed on the outer surface of the first end 2. The protrusions can be evenly and equidistantly distributed on the outer surface of the first end 2, or they can be unevenly distributed.

[0130] More preferably, the protrusion is fixedly connected to the outer surface of the first end 2, such as by bonding. In this embodiment, the protrusion is integrally formed with the first end 2, which not only simplifies the process but also improves the structural stability.

[0131] It should be noted that the protrusion can increase the coefficient of friction of the outer surface of the first end 2, so that the gripping pincers can grip the first end 2 more firmly.

[0132] In one embodiment, the wall thickness of the proximal end 32 of the second end 3 is greater than the wall thickness of the distal end 31 of the second end 3, such as... Figures 1 to 8 As shown.

[0133] Preferably, the wall thickness of the distal end 31 of the second end 3 is any value between 0.3 mm and 0.85 mm, such as 0.3 mm, 0.31 mm, 0.32 mm, 0.33 mm, 0.34 mm, 0.35 mm, 0.36 mm, 0.37 mm, 0.38 mm, 0.39 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.85 mm, etc.

[0134] More preferably, the wall thickness of the proximal end of the second end 3 is any value between 2mm and 3.5mm, such as 2mm, 2.1mm, 2.2mm, 2.3mm, 2.4mm, 2.5mm, 2.6mm, 2.7mm, 2.8mm, 2.9mm, 3mm, 3.1mm, 3.2mm, 3.3mm, 3.4mm, 3.5mm, etc. The specific value can be set as needed and is not specifically limited here.

[0135] It should be noted that the wall thickness of the proximal end 32 of the second end 3 is greater than that of its distal end 31, thereby enhancing the structural strength of the second end 3 so as to prevent deformation from hindering entry when implanted into the bronchus 300.

[0136] In one embodiment, the hardness of the proximal end 32 of the second end 3 is greater than the hardness of the distal end 31 of the second end 3, such as... Figures 1 to 8 As shown.

[0137] Preferably, the hardness of the proximal end 32 of the second end 3 is greater than or equal to 40A and less than 60A, such as 40A, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 50A, 55A, 59A, etc. The specific value can be set as needed and is not specifically limited here.

[0138] It should be noted that the hardness range of the proximal end 32 of the second end 3 is preferably greater than or equal to 50A and less than 60A in order to achieve the best effect.

[0139] More preferably, the hardness of the distal end 31 of the second end 3 is any value between 20A and 35A, such as 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 31A, 32A, 33A, 34A, 35A, etc.

[0140] It should be noted that the hardness range of the distal end 31 of the second end 3 is preferably any value between 20A and 30A in order to achieve the best effect and prevent the inner wall of the bronchus 300 from being scratched or punctured due to excessive hardness during implantation, thus ensuring higher safety.

[0141] Preferably, the hardness of the proximal end 32 of the second end 3 is greater than that of the distal end 31, which not only ensures the stability of the structure and effectively prevents deformation when implanted into the bronchus 300, but also prevents scratching or puncturing the inner wall of the bronchus 300, ensuring the safety of use.

[0142] In one embodiment, the hardness of the second end portion 3 is less than the hardness of the fixing portion 1, such as... Figures 1 to 8 As shown.

[0143] Preferably, the hardness range of the second end 3 is greater than or equal to 20A and less than 60A, such as 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 40A, 50A, 59A, etc. The specific value can be set as needed and is not specifically limited here.

[0144] More preferably, the hardness range of the fixing part 1 is as described above, and will not be repeated here.

[0145] Preferably, the hardness of the second end 3 is less than that of the fixing part 1, thereby effectively reducing the radial support force of the second end 3 on the inner wall of the bronchus 300, effectively preventing granulation tissue proliferation between the second end 3 and the inner wall of the bronchus 300, and extending its service life.

[0146] In one embodiment, the hardness of the outer wall of the second end 3 is less than the hardness of the inner wall of the second end 3, such as... Figures 1 to 8 As shown.

[0147] Preferably, the hardness of the outer wall of the second end 3 is any value between 20A and 35A, such as 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 31A, 32A, 33A, 34A, 35A, etc.

[0148] It should be noted that the hardness of the outer wall of the second end 3 is preferably any value between 20A and 30A to achieve the best effect.

[0149] More preferably, the hardness range of the inner wall of the second end 3 is greater than or equal to 40A and less than 60A, such as 40A, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 50A, 55A, 59A, etc. The specific value can be set as needed and is not specifically limited here.

[0150] It should be noted that the hardness range of the inner wall of the second end 3 is preferably greater than or equal to 50A and less than 60A, so as to achieve the best effect.

[0151] More preferably, the hardness of the outer wall of the second end 3 is less than that of its inner wall, thereby reducing the stimulation to the inner wall of the bronchus 300 and effectively preventing granulation tissue hyperplasia.

[0152] In one embodiment, the outer wall of the proximal end of the second end portion 3 is provided with an arcuate surface 33 that connects to the outer wall of the fixing portion 1, such as... Figures 1 to 8 As shown.

[0153] Preferably, the arc-shaped surface 33 is disposed on the outer wall of the second end 3 near the fixing part 1. The radius of the arc-shaped surface 33 is any value between 2mm and 4mm, such as 2mm, 3mm, 4mm, etc. The specific value can be set as needed and is not specifically limited here. It should be noted that the radius of the arc-shaped surface 33 is preferably any value between 2.5mm and 3mm to achieve the best effect.

[0154] It should be noted that the design of the arc-shaped surface 33 creates a large gap between the arc-shaped surface 33 and the inner wall of the bronchus 300, thereby providing sufficient space for granulation tissue growth and prolonging the time for granulation tissue to penetrate into the cavity 7.

[0155] In one embodiment, the outer wall of the second end portion 3 is provided with a plurality of protrusions (not shown), such as... Figures 1 to 8 As shown.

[0156] Preferably, the protrusions are provided in multiple portions and distributed on the outer wall of the second end portion 3. The protrusions are evenly distributed on the outer wall of the second end portion 3, or they may be unevenly distributed.

[0157] More preferably, the protrusion is fixedly connected to the second end 3, such as by bonding. In this embodiment, the protrusion and the second end 3 are integrally formed, which not only simplifies the process but also improves the structural stability.

[0158] It should be noted that the protrusion can support the second end 3, thereby increasing the gap between the second end 3 and the inner wall of the bronchus 300, so as to provide sufficient space for granulation tissue growth.

[0159] In one embodiment, the roughness of the outer surface of the second end portion 3 is less than the roughness of the outer surface of the fixing portion 1, such as... Figures 1 to 8 As shown.

[0160] Preferably, the roughness of the outer surface of the second end 3 is any value between 1um and 3um, such as 1um, 2um, 3um, etc. The specific value can be set as needed and is not specifically limited here.

[0161] It should be noted that the roughness of the outer surface of the second end 3 is preferably any value between 1 μm and 1.2 μm in order to achieve the best effect.

[0162] More preferably, the range of roughness of the outer surface of the fixing part 1 is as described above, and will not be repeated here.

[0163] Preferably, the roughness of the outer surface of the second end 3 is less than the roughness of the outer surface of the fixing part 1, thereby reducing the friction between the emphysema treatment device 100 and the inner wall of the bronchus 300 when the device is implanted into the bronchus 300, making it easier to implant into the bronchus 300, reducing the difficulty of operation, and improving the safety of the surgery.

[0164] In one embodiment, the roughness of the outer surface of the second end 3 is less than the roughness of the outer surface of the first end 2, such as... Figures 1 to 8 As shown.

[0165] Preferably, the roughness range of the outer surface of the second end 3 can be referred to the above-mentioned relevant description, and will not be repeated here.

[0166] More preferably, the range of roughness of the outer surface of the first end 2 can be referred to the above-mentioned relevant description, and will not be repeated here.

[0167] Preferably, the roughness of the outer surface of the second end 3 is less than the roughness of the outer surface of the first end 2, thereby reducing the friction between the emphysema treatment device 100 and the inner wall of the bronchus 300 when the device is implanted into the bronchus 300, making it easier to implant into the bronchus 300, reducing the difficulty of operation, and improving the safety of the surgery.

[0168] In one embodiment, the roughness of the outer surface of the second end 3 is greater than the roughness of the inner surface of the cavity 7.

[0169] Preferably, the roughness range of the outer surface of the second end 3 can be referred to the above-mentioned relevant description, and will not be repeated here.

[0170] More preferably, the roughness of the inner surface of the cavity 7 is any value between 0.001um and 1.6um, such as 0.001um, 0.002um, 0.003um, 0.004um, 0.005um, 0.006um, 0.007um, 0.008um, 0.009um, 0.01um, 0.02um, 0.03um, 0.04um, 0.05um, 0.06um, 0.07um, 0.08um, 0.09um, 0.1um, 0.5um, 1um, 1.5um, 1.6um, etc. The specific value can be set as needed and is not specifically limited here.

[0171] It should be noted that the roughness of the inner surface of cavity 7 is preferably any value between 0.001um and 0.2um, and is not specifically limited here.

[0172] It should also be noted that the smaller roughness of the inner surface of cavity 7 makes it easier for gas to flow through quickly, and can even accelerate the passage of liquids through cavity 7, thus improving the effect of gas and liquid passage.

[0173] 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, It includes a fixing part, a first end and a second end respectively disposed at the proximal end and the distal end of the fixing part, the first end, the fixing part and the second end surround to form a cavity, the proximal end of the first end is provided with an air inlet communicating with the cavity, and the distal end of the second end is provided with an air outlet communicating with the cavity, the maximum outer diameter of the first end and the maximum outer diameter of the second end are both smaller than the outer diameter of the fixing part.

2. The emphysema treatment device according to claim 1, characterized in that, The cavity has a first constriction and a second constriction. The first constriction is connected to the air inlet, and the second constriction is connected to the air outlet. The second constriction has an ending surface. The cavity has two arbitrary points, a first point and a second point, on its inner wall near the first constriction. The first point is located between the first constriction and the second point. The cavity also has two arbitrary points, a third point and a fourth point, on its inner wall near the second constriction. The third point is located between the second constriction and the fourth point. A ray that perpendicularly passes through the ending surface and extends toward the distal end is defined as a normal. The angle e between the ray with the first point as its endpoint and passing through the second point and the normal is less than 90°. The angle f between the ray with the fourth point as its endpoint and passing through the third point and the normal satisfies 90°≤f≤180°.

3. The emphysema treatment device according to claim 1, characterized in that, The first end, the fixing part, and the second end are coaxially arranged. The outer diameter of the fixing part is constant. In the direction from the proximal end to the distal end, the outer diameter of the first end increases and / or the outer diameter of the second end decreases.

4. The emphysema treatment device according to claim 1, characterized in that, The emphysema treatment device further includes an isolation section, which is connected to the fixing section and surrounds the first end and / or the second end.

5. The emphysema treatment device according to any one of claims 1-4, characterized in that, The outer diameter of any part of the first end is D1, and the outer diameter of the fixing part is D2, wherein 30% ≤ D1 / D2 ≤ 90%; And / or, the wall thickness of the first end is greater than the wall thickness of the isolation portion; And / or, the hardness of the first end is greater than the hardness of the insulating portion; And / or, in the direction from the proximal end to the distal end, the length of the first end is greater than the length of the isolation portion.

6. The emphysema treatment device according to claim 5, characterized in that, The hardness of the first end is less than the hardness of the fixing part; And / or, the hardness of the proximal end of the first end is less than the hardness of the distal end of the first end; And / or, the roughness of the outer surface of the first end is greater than the roughness of the isolation portion.

7. The emphysema treatment device according to claim 5, characterized in that, The roughness of the outer surface of the first end is greater than the roughness of the fixing part; And / or, the hardness of the outer wall of the first end is less than the hardness of the inner wall of the first end; And / or, the outer wall of the first end is provided with a plurality of protrusions.

8. The emphysema treatment device according to claim 5, characterized in that, The wall thickness at the proximal end of the second end is greater than the wall thickness at the distal end of the second end; And / or, the hardness of the proximal end of the second end is greater than the hardness of the distal end of the second end; And / or, the hardness of the second end is less than the hardness of the fixing part.

9. The emphysema treatment device according to claim 5, characterized in that, The hardness of the outer wall of the second end is less than the hardness of the inner wall of the second end; And / or, the outer wall of the proximal end of the second end is provided with an arcuate surface that connects to the outer wall of the fixing part; And / or, the outer wall of the second end is provided with a plurality of protrusions.

10. The emphysema treatment device according to claim 5, characterized in that, The roughness of the outer surface of the second end is less than the roughness of the outer surface of the fixing part.

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