Implant conveying device

Abstract

The invention provides an implant delivery device which comprises a guide structure and a pushing part, the guide structure comprises a catheter and an expansion fixing part, one end of the catheter is communicated with the expansion fixing part, the other end of the catheter extends out of a patient body, and the expansion fixing part is used for extending into a bronchus and being fixed in the bronchus when injected fluid expands. The catheter is used for penetrating through the interiors of the pushing part and the implant, and the far end of the pushing part abuts against the near end of the implant, so that the pushing part pushes the implant to slide to a target position in the bronchus along the catheter. The distal end of the catheter is fixed to the bronchus in advance through the expansion fixing part, the catheter penetrates through the pushing part, and therefore the pushing part can quickly and accurately push the implant on the catheter to the target position in the bronchus, the difficulty of surgical operation is lowered, the surgical efficiency is improved, the pain of a patient is relieved, and safety is high.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a delivery device for an implant. Background Art

[0002] The incidence and mortality rates of chronic respiratory diseases are relatively high. Especially in patients with severe emphysema phenotypes, the effect of drug treatment is often poor. In this case, bronchoscopic lung volume reduction surgery has become an effective treatment method, which can improve the lung function of patients to a certain extent.

[0003] Bronchoscopic lung volume reduction surgery is to implant an implant into the tissue of the lesion area through a bronchoscope. The implant can reduce the volume of gas flowing into the distal airway, and at the same time allow gas to flow out of the distal airway normally, so as to achieve the effect of reducing the volume of part of the lung lobe. This volume reduction effect helps to improve the respiratory function and quality of life of patients.

[0004] In the existing implant delivery technology with a central channel in the bronchus, a biopsy forceps is usually used to clamp and deliver the implant to the target airway through the instrument channel of the bronchoscope. In this process, first, the endoscope is used for positioning to ensure that the implant carried by the biopsy forceps accurately reaches the predetermined position. Subsequently, the implant is released by adjusting the push and twist of the biopsy forceps to complete the implantation process. However, this traditional method has several limitations, mainly reflected in the following aspects: Since the biopsy forceps is located in the instrument channel of the endoscope, this limits the bending ability of the endoscope. Especially when facing bronchi with a large bending degree, it is difficult for the endoscope to smoothly enter the target area; during the process of using the biopsy forceps to clamp the implant, it is easy to cause physical damage to the implant, which may lead to failure to achieve the expected treatment effect after surgery; since the biopsy forceps only clamps a part of the implant, the implant is subjected to uneven stress, which in turn causes deformation or damage, affecting the treatment effect. During the pushing process, the control force of the biopsy forceps on the distal end of the implant is weak. Especially when the implant contacts the bronchial wall, it is easy to deviate, making it difficult for the implant to accurately enter the target bronchus; when the bending angle of the target bronchus is relatively large, it is difficult for the implant to smoothly enter the branch bronchus. Especially in the case of requiring precise positioning, the complexity of endoscope operation increases significantly; when finally releasing the implant, loosening the jaws of the biopsy forceps and withdrawing the biopsy forceps may cause the implant to shift, increasing the risk of the implant prolapsing due to coughing and other reasons after surgery.

[0005] Therefore, there is an urgent need for a new delivery device for implants to solve the above technical problems. Summary of the Invention

[0006] In order to overcome the above technical problems, the present invention provides a delivery device for an implant that can solve the above technical problems.

[0007] As described above, the technical solution adopted by the present invention is as follows:

[0008] A delivery device for an implant, comprising a guiding structure and a pushing member. The guiding structure includes a catheter and an expansion fixing member. One end of the catheter is communicated with the expansion fixing member and the other end extends out of the patient's body. The expansion fixing member is used to extend into the bronchus and be fixed in the bronchus when inflated by injecting fluid. The catheter is used to pass through the inside of the pushing member and the implant respectively. The distal end of the pushing member abuts against the proximal end of the implant, so that the pushing member can push the implant to slide along the catheter to the target position in the bronchus.

[0009] The present invention has at least the following beneficial effects:

[0010] The delivery device of the implant of the present invention pre-fixes the distal end of the catheter in the bronchus through the expansion fixing member, and the catheter passes through the pushing member, so that the pushing member can quickly and accurately push the implant on the catheter to the target position in the bronchus, reducing the difficulty of surgical operation, improving the surgical efficiency, reducing the pain of the patient, and having high safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a schematic structural diagram of the delivery device of the implant of the present invention;

[0012] Figure 2 is a schematic structural diagram of another embodiment of the delivery device of the implant of the present invention;

[0013] Figure 3 is a schematic structural diagram of still another embodiment of the delivery device of the implant of the present invention;

[0014] Figure 4 is Figure 1 a schematic diagram of the first embodiment of the guiding structure of the delivery device of the implant of the present invention shown;

[0015] Figure 5 is Figure 1 a schematic diagram of the second embodiment of the guiding structure of the delivery device of the implant of the present invention shown;

[0016] Figure 6 is Figure 1 a schematic diagram of the third embodiment of the guiding structure of the delivery device of the implant of the present invention shown;

[0017] Figure 7 is Figure 1 a schematic diagram of the fourth embodiment of the guiding structure of the delivery device of the implant of the present invention shown;

[0018] Figure 8 is Figure 1Schematic diagram of the fifth embodiment of the guiding structure of the delivery device of the implant of the present invention;

[0019] Figure 9 is Figure 1 Schematic diagram of the sixth embodiment of the guiding structure of the delivery device of the implant of the present invention;

[0020] Figure 10 is Figure 1 Schematic diagram of the seventh embodiment of the guiding structure of the delivery device of the implant of the present invention;

[0021] Figure 11 is Figure 10 Schematic diagram of another embodiment of the guiding structure shown;

[0022] Figure 12 is Figure 1 Schematic diagram of the first embodiment of the pusher of the delivery device of the implant of the present invention;

[0023] Figure 13 is Figure 1 Schematic diagram of the second embodiment of the pusher of the delivery device of the implant of the present invention;

[0024] Figure 14 is Figure 1 Schematic diagram of the third embodiment of the pusher of the delivery device of the implant of the present invention;

[0025] Figure 15 is Figure 1 Schematic diagram of the fourth embodiment of the pusher of the delivery device of the implant of the present invention;

[0026] Figure 16 is Figure 1 Schematic diagram of the abutting portion of the delivery device of the implant of the present invention;

[0027] Figure 17 is Figure 16 Cross-sectional view of the abutting portion shown;

[0028] Figure 18 is Figure 1 Schematic diagram of the fifth embodiment of the pusher of the delivery device of the implant of the present invention;

[0029] Figure 19 is Figure 1 Schematic diagram of the sixth embodiment of the pusher of the delivery device of the implant of the present invention;

[0030] Figure 20 is Figure 1 Schematic diagram of the seventh embodiment of the pusher of the delivery device of the implant of the present invention;

[0031] Figure 21 isFigure 1 Schematic diagram of the eighth embodiment of the pusher of the delivery device of the implant of the present invention;

[0032] Figure 22 is Figure 1 Schematic diagram of the ninth embodiment of the pusher of the delivery device of the implant of the present invention;

[0033] Figure 23 Schematic diagram of the delivery device of the implant of the present invention during use.

[0034] Explanation of the reference numerals in the drawings:

[0035] 100 - Delivery device of the implant; 1 - Guiding structure; 11 - Catheter; 111 - Bent portion; 12 - Expansion fixing member; 121 - Projection; 13 - Imaging member; 14 - Thread; 2, 2', 2'', 2''', 2'''' - Pusher; 21 - Pushing portion; 211 - Main body portion; 2111 - Third through - hole; 2112 - Notch; 2113 - First part; 2114 - Second part; 212 - Connecting portion; 213 - Notch; 214 - Bending portion; 215 - Thinning portion; 22 - Abutting portion; 221 - Body portion; 222 - Distal end portion; 223 - Proximal end portion; 224 - First through - hole; 24 - Handle; 3 - Bronchus; 4 - Implant. Detailed implementation manners

[0036] The following will clearly and completely describe the delivery device of the implant provided by the present invention with reference to the accompanying drawings. It can be understood that the described embodiments are only partial embodiments of the present invention, not all embodiments, and the present invention can be implemented in many other ways different from those described herein.

[0037] Unless otherwise defined, all technical terms and scientific terms used in this specification have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs. The terms used in this specification are only for describing specific embodiments and are not intended to limit the present invention.

[0038] It should be noted that all directional indications in the embodiments of this specification are only used to explain the relative position relationship and movement conditions between components in a specific posture. If this specific posture changes, the directional indications will also change accordingly.

[0039] In addition, in the present invention, descriptions such as "first" and "second" are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of this specification, "a plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0040] The technical solutions of the various embodiments of the present invention can be combined with each other, but it must be based on the ability of those of ordinary skill in the art to implement. When the combination of technical solutions results in contradictions or is unable to be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0041] In this specification, the axial direction refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the component; the radial direction refers to the direction perpendicular to the above-mentioned axial direction.

[0042] In one embodiment, a delivery device 100 for an implant includes a guiding structure 1 and a pusher 2. The guiding structure 1 includes a catheter 11 and an expansion fixing member 12, as Figures 1 to 23 shown.

[0043] Preferably, the guiding structure 1 is used to guide and direct the pusher 2 and the implant 4, so that the pusher 2 pushes the implant 4 to slide along the guiding structure 1 to the target position in the bronchus 3.

[0044] It should be noted that: the above-mentioned target position is the position in the bronchus 3 where the implant 4 needs to be implanted, such as the diseased position in the bronchus 3 of the patient, etc.

[0045] More preferably, the guiding structure 1 can be a structure such as a catheter, which belongs to the prior art and will not be elaborated here.

[0046] Still more preferably, the pusher 2 is slidably arranged on the guiding structure 1 and slides into the bronchus 3 along with the guiding structure 1, thereby reducing the operation difficulty and improving the success rate.

[0047] Also preferably, the catheter 11 is in a long strip shape. The distal end of the catheter 11 is used to be inserted into the bronchus 3, and the proximal end of the catheter 11 is outside the body, so as to inject fluid through the proximal end of the catheter 11 outside the body.

[0048] It should be noted that: the hardness of the distal end of the catheter 11 is less than that of the rest of the part, so that the distal end of the catheter 11 will not damage the inner wall of the bronchus when extending into the bronchus, reducing the damage to the patient and having high safety.

[0049] Further preferably, the catheter 11 is a hollow tubular structure, and an inner cavity communicating with both ends is provided inside it, so as to inject fluid into its interior from the proximal end of the catheter 11.

[0050] It should be noted that: the above-mentioned proximal end is the end close to the operator, and the above-mentioned distal end is the end far from the operator.

[0051] Furthermore, the cross-section of the catheter 11 can be circular, rectangular or other geometric shapes, etc., and no specific limitation is made here.

[0052] Further, the expansion fixing member 12 is disposed at the distal end of the catheter 11 so as to extend into the bronchus 3 along with the distal end of the catheter 11 and is used for fixing within the bronchus 3.

[0053] Furthermore, the expansion fixing member 12 is preferably a balloon, such as a conventional balloon or a special-shaped balloon, etc. For example, a plurality of bumps 121 are provided on the expansion fixing member 12, such as Figure 11 shown, the setting of the special-shaped balloon increases the anchoring force of the expansion fixing member 12 within the bronchus 3, making its stabilizing effect more ideal.

[0054] It should be noted that: One or more expansion fixing members 12 can be provided, and they can be set according to needs, and no specific limitation is made here.

[0055] More particularly, the distal end of the catheter 11 is fixedly connected to the expansion fixing member 12, such as by bonding, welding, hot melting, integral molding, etc., and it can be set according to needs, and no specific limitation is made here.

[0056] In one embodiment, one end of the catheter 11 communicates with the expansion fixing member 12 and the other end extends out of the patient's body. The expansion fixing member 12 is used for extending into the bronchus 3 and fixing within the bronchus 3 when inflated by injecting fluid, such as Figures 1 to 23 shown,

[0057] Preferably, the expansion fixing member 12 communicates with the distal end of the catheter 11, that is, the interior of the catheter 11 communicates with the interior of the expansion fixing member 12, so as to inject fluid, etc. into the interior of the expansion fixing member 12 through the catheter 11.

[0058] It should be noted that: The above-mentioned injected fluid is injected gas or liquid, etc., and it can be set according to needs, and no specific limitation is made here.

[0059] More preferably, when the expansion fixing member 12 is injected with fluid, it expands, increasing its volume, so that the outer surface of the expansion fixing member 12 abuts against the inner wall of the bronchus 3, achieving the purpose of fixing the expansion fixing member 12 within the bronchus 3; when the fluid within the expansion fixing member 12 is withdrawn, the expansion fixing member 12 will contract and recover to facilitate its removal from the bronchus 3.

[0060] Still more preferably, the expansion fixing member 12 can expand entirely or partially when expanding, etc.

[0061] Also preferably, the proximal end of the catheter 11 extends out of the patient's body, so as to facilitate the operator to inject fluid, etc. into its interior through the proximal end of the catheter 11, and then the injected fluid flows into the expansion fixing member 12 to make it expand.

[0062] In one embodiment, the catheter 11 is configured to pass through the inside of the pusher 2 and the implant 4 respectively, as Figures 1 to 23 shown.

[0063] Preferably, the catheter 11 passes through the inside of the implant 4, and the implant 4 is slidable on the catheter 11, so that the implant 4 can slide from the proximal end to the distal end on the catheter 11 until it slides to the target position in the bronchus 3, so as to achieve the purpose of implantation, with simple operation and convenient use.

[0064] It should be noted that: precisely due to the above limitations, after the distal end of the catheter 11 is pre-fixed in the bronchus 3 through the expansion fixing member 12, the implant 4 can be accurately and quickly implanted into the target position in the bronchus 3 along the catheter 11, which not only reduces the operation difficulty, but also improves the surgical success rate and efficiency, effectively reduces the pain of the patient, and reduces the harm caused to the patient.

[0065] More preferably, the catheter 11 can pass through the entire implant 4 or a part of the implant 4, which can be selected and set according to needs and will not be specifically limited herein. After the catheter 11 passes through the implant 4, it has a clearance fit with it, that is, there is a clearance between the outer surface of the catheter 11 and the inner surface of the implant 4, so that the implant 4 can slide smoothly on the catheter 11 and be implanted into the target position.

[0066] Still more preferably, the catheter 11 passes through the inside of the pusher 2, and the pusher 2 is slidable on the catheter 11, so that the pusher 2 can move from the proximal end to the distal end on the catheter 11 to push the implant 4 to the target position in the bronchus 3.

[0067] Also preferably, the implant 4 is located at the distal end of the pusher 2, so as to achieve the purpose of the pusher 2 pushing the implant 4 distally.

[0068] Further preferably, the catheter 11 passes through the entire pusher 2 or a part of the pusher 2, which can be set according to needs and will not be specifically limited herein. After the catheter 11 passes through the pusher 2, it has a clearance fit with it, that is, there is a clearance between the outer surface of the catheter 11 and the inner surface of the pusher 2, so that the pusher 2 can move smoothly on the catheter 11 to push the implant 4 into the target position.

[0069] It should be further noted that: the situation where the catheter 11 passes through at least a part of the pusher 2 includes the following cases: the first case, as Figure 1 shown, the catheter 11 penetrates the proximal end face and the distal end face of the pusher 2, that is, the catheter 11 penetrates the entire cavity inside the pusher 2, and the pusher 2 can slide from the proximal end to the distal end on the catheter 11; the second case, as Figure 2As shown, the outer peripheral surface of the pusher 2 is provided with a third through-hole 2111 communicating with its internal cavity. The distal end of the catheter 11 passes through the third through-hole 2111 and extends into the internal cavity of the pusher 2, and extends out from the distal end of the pusher 2, that is, the catheter 11 only passes through a part of the internal cavity of the pusher 2; in the third case, as Figure 3 shown, the pusher 2 is provided with a notch 2112. The catheter 11 passes through the notch 2112 and extends out from the distal end of the pusher 2. At this time, the catheter 11 can pass through all of the internal cavity of the pusher 2 or can also pass through a part of the internal cavity of the pusher 2, etc. In other embodiments, the catheter 11 and the pusher 2 can also adopt other connection methods, which are not specifically limited herein.

[0070] In one embodiment, the distal end of the pusher 2 abuts against the proximal end of the implant 4, so that the pusher 2 pushes the implant 4 to slide along the catheter 11 to the target position, as Figures 1 to 23 shown.

[0071] Preferably, the distal end of the pusher 2 abuts against the proximal end of the implant 4, that is, when pushing the implant 4, the distal end of the pusher 2 abuts against the proximal end of the implant 4 and pushes the implant 4 to push it to the target position in the bronchus 3. When the distal end of the pusher 2 is withdrawn back, the distal end of the pusher 2 can quickly disengage from the implant 4 to quickly remove the distal end of the pusher 2 from the bronchus 3, preventing the implant 4 from moving back, reducing the operation difficulty, reducing the damage to the patient, and improving the success rate.

[0072] More preferably, the distal end of the pusher 2 can abut against a part of the proximal end face of the implant 4 or can also abut against the entire proximal end face of the implant 4. The larger the area of the distal end of the pusher 2 abutting against the proximal end face of the implant 4, the more stable the pushing of the implant 4, effectively preventing the implant 4 from shifting during the implantation process.

[0073] Still more preferably, the pusher 2 pushes the implant 4 distally, so that the implant 4 slides along the catheter 11 to the target position in the bronchus 3, which not only reduces the implantation difficulty, but also prevents damage to the inner wall of the bronchus 3, and has high safety.

[0074] In one embodiment, the pusher 2 is a pusher tube 2', 2", 2"', 2"". The distal ends of the pusher tubes 2', 2", 2"', 2"" abut against the proximal end of the implant 4, as Figures 12 to 15 shown.

[0075] Preferably, the pusher 2 is a pusher tube, which is a single structural member, and the two ends of the pusher tube are communicated, so as to facilitate the catheter 11 to pass through the inside of the pusher 2.

[0076] More preferably, the pushing tube is made of a polymer material, preferably a transparent polymer material, and has a hardness greater than 80A, so that it can not only be smoothly implanted into the bronchus 3, but also the catheter 11 and the scale thereon can be seen through the pushing tube, thereby judging the position of the implant 4.

[0077] Even more preferably, the distal end of the pushing tube directly abuts against the proximal end of the implant 4, which not only simplifies the structure, but also can push the implant 4 to the target position more stably, reducing the operation difficulty.

[0078] Also preferably, the pushing tube can be a pipe with a uniform outer diameter, or a pipe with different outer diameters in different regions, etc., which can be set according to needs and will not be specifically limited here.

[0079] Further preferably, the catheter 11 passes through the inside of the pushing tube, so that the pushing tube can move from the proximal end to the distal end on the catheter 11 to meet the need of pushing the implant 4.

[0080] Furthermore, the outer diameter of the distal end of the pushing tube is the same as that of other regions, so that not only the distal end of the pushing tube abuts against the implant 4 to push the implant 4 to the target position, but also the molding process is simplified and it is convenient for processing and manufacturing.

[0081] In one embodiment, the distal ends of the pushing tubes 2”, 2”’, 2”” are conical, spherical or cylindrical, as Figures 13 to 15 shown.

[0082] Preferably, the distal end of the pushing tube 2” is conical, as Figure 13 shown. The distal end of the pushing tube 2” is its right end. In the direction from the proximal end to the distal end, the diameter of the distal end of the pushing tube 2” gradually increases, so as to increase the area where the distal end of the pushing tube 2” abuts against the proximal end of the implant 4, so as to stably push it to the target position.

[0083] It should be noted that: when the distal end of the pushing tube 2” is conical, it is preferably made by an opening process, which belongs to the prior art and will not be elaborated here.

[0084] More preferably, the distal end of the pushing tube is spherical, so that it can be smoothly implanted into the bronchus 3, reducing damage to the inner wall of the bronchus 3, and at the same time, the implant 4 can be smoothly pushed to the target position.

[0085] It should be noted that: when the distal end of the pushing tube is spherical, it is preferably made by a hot melting process, which belongs to the prior art and will not be elaborated here.

[0086] Even more preferably, the distal ends of the pushing tubes 2”’, 2”” are cylindrical, as Figure 14 and Figure 15As shown, it includes the following two cases: the outer diameter of the distal end of the pushing tube 2”’ is greater than that of the remaining area, as Figure 14 shown, or the outer diameter of the distal end of the pushing tube 2”” is less than that of the remaining area, as Figure 15 shown. It only needs the distal end of the pushing tube to be able to abut against the proximal end of the implant 4, and no specific limitation is made here.

[0087] It should be noted that when the distal ends of the pushing tubes 2”’ and 2”” are cylindrical, they can be injection-molded on the pushing tubes, which belongs to the prior art and no specific limitation is made here.

[0088] In one embodiment, the pushing member 2 includes a pushing portion 21 and an abutting portion 22 provided at the distal end of the pushing portion 21. The distal end of the pushing portion 21 is fixedly connected to the proximal end of the abutting portion 22, as Figures 1 to 3 、 Figures 18 to 22 shown.

[0089] Preferably, in this embodiment, the pushing member 2 is composed of two interconnected independent parts, namely the pushing portion 21 and the abutting portion 22.

[0090] More preferably, the pushing portion 21 is in a long strip shape, so as to facilitate extending into the bronchus 3 to push the implant 4 to the target position in the bronchus 3. The pushing portion 21 can be a cylinder, or a cuboid or other geometric bodies, etc., and no specific limitation is made here. In this embodiment, the pushing portion 21 is a cylinder.

[0091] Still more preferably, a cavity is provided inside the pushing portion 21, so that the catheter 11 at least passes through part of the inside of the pushing portion 21, enabling the pushing portion 21 to slide from its proximal end to the distal end on the catheter 11, and thus being able to more easily push the implant 4 on the catheter 11 to the target position, reducing the operation difficulty and improving the convenience of use.

[0092] Also preferably, when in use, the distal end of the pushing portion 21 extends into the bronchus 3, and the proximal end of the pushing portion 21 is outside the body, facilitating the operator to hold the proximal end of the pushing portion 21 to achieve the purpose of pushing the pushing portion 21.

[0093] Further preferably, the abutting portion 22 is provided at the distal end of the pushing portion 21. The abutting portion 22 can be a regular geometric body, such as a cylinder, a sphere, a cone and other geometric bodies, or can be a non-geometric body, such as a combination of multiple regular geometric bodies, etc., which can be set by the user according to needs, and no specific limitation is made here.

[0094] Furthermore, the abutting portion 22 can be hollow, so as to allow the pushing portion 21 and the catheter 11 to pass through, and no specific limitation is made here. The abutting portion 22 and the pushing portion 21 can be coaxially arranged, or can be non-coaxially arranged, etc. In this embodiment, the abutting portion and the pushing portion 21 are coaxially arranged.

[0095] Further, the distal end of the pushing part 21 is fixedly connected to the proximal end of the abutting part 22, such as interference fit, bonding, hot melting, integral molding, etc., which can be set by the user according to needs and will not be specifically limited herein.

[0096] Furthermore, the distal end of the pushing part 21 can extend into the interior of the abutting part 22 and be fixedly connected thereto, or the proximal end of the abutting part 22 can extend into the interior of the distal end of the pushing part 21 and be fixedly connected thereto, etc. Or the distal end face of the pushing part 21 abuts against the proximal end face of the abutting part 22 and is bonded or hot-melted, etc., which can be set by the user according to needs and will not be specifically limited herein.

[0097] In one embodiment, the distal end of the abutting part 22 abuts against the proximal end of the implant 4, as Figures 1 to 3 、 Figures 18 to 22 shown.

[0098] Preferably, the distal end of the abutting part 22 abuts against the proximal end of the implant 4, that is, when pushing the implant 4, the abutting part 22 abuts against the proximal end of the implant 4 and pushes the implant 4 to push it to the target position in the bronchus 3. When pulling back the abutting part 22, the abutting part 22 can quickly disengage from the implant 4 to quickly remove the abutting part 22 from the bronchus 3, preventing the implant from moving back, reducing the operation difficulty, reducing the damage to the patient, and improving the success rate.

[0099] More preferably, the abutting part 22 can abut against a part of the proximal end face of the implant 4 or can abut against the entire proximal end face of the implant 4. The larger the area of the abutting part 22 abutting against the proximal end face of the implant 4, the more stable the pushing of the implant 4 is, effectively preventing the implant 4 from shifting during the implantation process.

[0100] In one embodiment, the distal end of the abutting part 22 is hemispherical, as Figure 16 and Figure 17 shown.

[0101] Preferably, the distal end of the abutting part 22 is hemispherical, so that the distal end of the abutting part 22 can be smoothly implanted into the bronchus 3, preventing damage to the inner wall of the bronchus 3 and having high safety.

[0102] It should be noted that: in other embodiments, the abutting part 22 can also be conical or other geometric shapes, which can be set by the user according to needs and will not be specifically limited herein.

[0103] In one embodiment, the proximal end of the abutting part 22 is conical, and in the direction from the distal end to the proximal end, the diameter of the proximal end of the abutting part 22 gradually decreases, as Figure 16 and Figure 17 shown.

[0104] Preferably, the proximal end of the abutting portion 22 is conical, so that not only is it convenient to move it out of the bronchus 3 during removal, reducing damage to the inner wall of the bronchus 3, but also the material used can be reduced, thereby reducing costs.

[0105] More preferably, in the direction from the distal end to the proximal end, the diameter of the proximal end of the abutting portion 22 gradually decreases, so that it is conical, in order to reduce the damage to the inner wall of the bronchus 3 when moving out of the bronchus 3.

[0106] In one embodiment, the outer diameter of the middle portion of the abutting portion 22 is greater than the outer diameters of its proximal end and distal end, as Figure 16 and Figure 17 shown.

[0107] Preferably, the outer diameter of the middle portion of the abutting portion 22 is greater than the outer diameter of its distal portion, thereby reducing the damage to the inner wall of the bronchus 3 caused by the distal end of the abutting portion 22 during implantation, and having high safety.

[0108] It should be noted that: if the outer diameter of the middle portion of the abutting portion 22 is less than or equal to the outer diameter of its distal portion, it is likely to scratch the inner wall of the bronchus 3, increasing the pain of the patient and having low safety.

[0109] More preferably, in the direction from the distal end to the proximal end, the diameter of the distal end of the abutting portion 22 gradually increases, so that the outer surface of the abutting portion 22 is a smooth curved surface, and then it is smoothly implanted into the bronchus 3, reducing the implantation difficulty.

[0110] Still more preferably, the outer diameter of the middle portion of the abutting portion 22 is greater than the outer diameter of its proximal portion, thereby reducing the damage to the inner wall of the bronchus 3 caused by the proximal end of the abutting portion 22 during removal, and having high safety.

[0111] It should be noted that: if the outer diameter of the middle portion of the abutting portion 22 is less than or equal to the outer diameter of its proximal portion, it is likely to scratch the inner wall of the bronchus 3, increasing the pain of the patient and having low safety.

[0112] In one embodiment, the abutting portion 22 is conical.

[0113] Preferably, the abutting portion 22 is conical, and the area of the distal end surface of the abutting portion 22 is smaller than the area of its proximal end surface, so as to be beneficial to implanting into the bronchus 3 and reducing damage such as scratching to the inner wall of the bronchus 3.

[0114] In one embodiment, the abutting portion 22 is provided with a first through hole 224, and the distal end of the pushing portion 21 extends into the first through hole 224 and is in interference fit with the abutting portion 22, as Figures 1 to 3 , Figures 18 to 22 shown.

[0115] Preferably, the first through hole 224 axially penetrates through the end face of the abutting portion 22 so that the catheter 11 can pass through and accommodate the distal end of the pushing portion 21 to achieve a fixed connection between the two.

[0116] More preferably, the first through hole 224 can be cylindrical, or can be a cuboid or other geometric bodies, etc., and no specific limitation is made here.

[0117] Still more preferably, the first through hole 224 can extend in a straight line, or can be curved, wavy, etc., which can be set by the user according to needs, and no specific limitation is made here.

[0118] Also preferably, the distal end of the pushing portion 21 is accommodated in the first through hole 224 to achieve a firm connection between the two.

[0119] Further preferably, the distal end of the pushing portion 21 and the abutting portion 22 are in interference fit, so as to achieve a firm connection between the two, effectively prevent the abutting portion 22 from shaking on the distal end of the pushing portion 21, ensure the stability of use, and prevent the abutting portion 22 from detaching from the distal end face of the pushing portion 21 and remaining in the bronchus 3, ensuring the safety of use.

[0120] It should be noted that when the distal end of the pushing portion 21 and the abutting portion 22 are in interference fit, the outer surface of the distal end of the pushing portion 21 abuts against the inner circumferential surface of the abutting portion 22 to increase the contact area and make their connection more firm.

[0121] Furthermore, the outer diameter of the distal end of the pushing portion 21 is larger than the outer diameter of the rest of the portion, so as to increase the interference fit force between it and the abutting portion 22, improve the firmness of the connection, and also facilitate the catheter passing through its interior to enter or withdraw from its distal end, etc.

[0122] Still further, the distal end of the pushing portion 21 can be made by different types of forming processes, such as a cone formed by an opening process, a sphere formed by a hot melting process, a cylinder formed by an injection molding process, etc., which can be selected and set according to needs, and no specific limitation is made here.

[0123] In one embodiment, an adhesive is provided between the distal end of the pushing portion 21 and the abutting portion 22.

[0124] Preferably, an adhesive is provided between the inner circumferential surface of the abutting portion 22 and the outer circumferential surface of the pushing portion 21, so as to further enhance the firmness of the connection between the two and effectively prevent the two from detaching.

[0125] More preferably, the adhesive can cover a partial area or the entire area where the inner circumferential surface of the abutting portion 22 contacts the outer circumferential surface of the pushing portion 21, etc., which can be set by the user according to needs, and no specific limitation is made here.

[0126] It should be noted that: the larger the area covered by the adhesive, the more stable the connection between the pushing part 21 and the abutting part 22.

[0127] More preferably, the adhesive can be disposed between the abutting part 22 and the pushing part 21 when they are in interference fit, or can also be disposed between them when they are not in interference fit. The user can set it according to needs and no specific limitation is made here.

[0128] In one embodiment, the distance t between the distal end surface of the abutting part 22 and the distal end surface of the pushing part 21 satisfies 0.1mm ≤ t ≤ 6mm, as Figure 18 shown.

[0129] Preferably, the distance t between the distal end surface of the abutting part 22 and the distal end surface of the pushing part 21 can be any value between 0.1mm and 6mm, such as 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm, 4.5mm, 5mm, 5.5mm, 6mm, etc. Its specific value can be set according to needs and no specific limitation is made here.

[0130] It should be noted that: precisely the above limitation of the t range reduces the probability of direct contact between the pushing part 21 and the implant 4, effectively reducing the possible damage caused by the pushing part 21 rubbing or colliding with the surface of the implant 4, with high safety, and at the same time reducing the risk of the abutting part 22 falling off from the distal end of the pushing part 21.

[0131] More preferably, the preferred range of t is 1mm to 3mm, so as to optimize the above effects.

[0132] In one embodiment, the abutting part 22 includes an inner part 2242 close to the central axis and an outer part 2212 far from the central axis. The hardness y1 of the inner part 2242 satisfies 20A ≤ y1 ≤ 50A, and the hardness y2 of the outer part 2212 satisfies y2 < 30A. The hardness of the inner part 2242 is greater than that of the outer part 2212, as Figure 17 shown.

[0133] Preferably, the inner part 2242 is the part close to the central axis of the abutting part 22. The range of the hardness y1 of the inner part 2242 is any value between 20A and 50A, such as 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 35A, 40A, 45A, 50A, etc. Its specific value can be set according to needs and no specific limitation is made here.

[0134] More preferably, the outer portion 2212 is the part away from the central axis of the abutting portion 22, and the hardness y2 of the outer portion 2212 ranges from any value less than 30A, such as 29A, 28A, 27A, 26A, 25A, 24A, 23A, 22A, 21A, 20A, 15A, 10A, 5A, etc. Its specific value can be set according to needs and is not specifically limited here.

[0135] More preferably, the volume of the outer portion 2212 accounts for 20% to 40% of the volume of the abutting portion 22, such as 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 35%, 40%, etc. Its specific value can be set according to needs and is not specifically limited here.

[0136] Even more preferably, the hardness of the inner portion 2242 is greater than that of the outer portion 2212. Thus, on the one hand, a firm connection is achieved between the inner portion 2242 and the distal end of the pushing portion 21, and the pushing portion 21 applies a stable driving force to the abutting portion 22. On the other hand, it prevents the pressure and scratching caused by the outer portion 2212 on the inner wall of the bronchus 3.

[0137] In one embodiment, the maximum outer diameter r1 of the abutting portion 22 satisfies 2 mm ≤ r1 ≤ 6 mm, as Figure 17 shown.

[0138] Preferably, the maximum outer diameter r1 of the abutting portion 22 is the maximum outer diameter of its middle part, which is any value between 2 mm and 6 mm, such as 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, etc. Its specific value can be set according to needs and is not specifically limited here.

[0139] It should be noted that: precisely the limitation of the maximum outer diameter range of the abutting portion 22 can not only provide stable propulsion force and control, but also will not insert into the central hole of the implant 4, and at the same time is smaller than the outer diameter of the implant 4, reducing the friction on the inner wall of the bronchus 3 and protecting the airway structure.

[0140] In one embodiment, the implant 4 includes a second through hole (not shown), the catheter 11 passes through the second through hole, and the maximum outer diameter r1 of the abutting portion 22, the inner diameter r2 of the second through hole, and the maximum outer diameter r3 of the implant 4 satisfy r2 < r1 < r3, as Figure 17 shown.

[0141] Preferably, the second through-hole axially penetrates through both end faces of the implant 4, thus facilitating the catheter 11 to pass through.

[0142] More preferably, the relationship between the maximum outer diameter r1 of the abutting portion 22 and the inner diameter r2 of the second through-hole is r2 < r1, so that the abutting portion 22 does not entirely extend into the second through-hole, in order to enable the abutting portion 22 to abut against the proximal end of the implant 4, and further push it to the target position within the bronchus 3.

[0143] More preferably, the relationship between the maximum outer diameter r1 of the abutting portion 22 and the inner diameter r2 of the second through-hole is preferably 1.1r2 < r1, so that the abutting portion 22 can more firmly abut against the proximal end of the implant 4, in order to firmly push the implant 4 to the target position within the bronchus 3.

[0144] Still more preferably, the relationship between the maximum outer diameter r1 of the abutting portion 22 and the maximum outer diameter r3 of the implant 4 is r1 < r3, so that during the implantation process, the scratching and increased pressure on the inner wall of the bronchus 3 caused by the outer surface of the abutting portion 22 are reduced, in order to stably implant the implant 4 to the target position within the bronchus 3.

[0145] Also preferably, the relationship between the maximum outer diameter r1 of the abutting portion 22 and the maximum outer diameter r3 of the implant 4 is preferably r1 < 0.95r3, so as to ensure the gap between the outer surface of the abutting portion 22 and the inner wall of the bronchus 3 and prevent scratching of the inner wall of the bronchus 3.

[0146] In one embodiment, the inner diameter r4 of the first through-hole 224 satisfies 1 mm ≤ r4 ≤ 3 mm, and the outer diameter r5 of the pushing portion 21 satisfies 2 mm ≤ r5 ≤ 4 mm, as Figure 12 and Figure 17 shown.

[0147] Preferably, the inner diameter r4 of the first through-hole 224 is any value between 1 mm and 3 mm, such as 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.5 mm, 3 mm, etc. Its specific value can be set according to needs and is not specifically limited here.

[0148] It should be noted that: precisely the limitation of the range of the inner diameter of the first through-hole 224 facilitates, on the one hand, accommodating the distal end of the pushing portion 21, and on the other hand, realizes the fixed connection between the distal end of the pushing portion 21 and the abutting portion 22.

[0149] More preferably, the outer diameter r5 of the pushing part 21 is any value between 2 mm and 4 mm, such as 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.5 mm, 4 mm, etc. Its specific value can be set according to needs and is not specifically limited herein.

[0150] It should be noted that: precisely by limiting the range of the outer diameter of the pushing part 21 as described above, the pushing part 21 can be implanted into the bronchus 3, and can provide a stable supporting effect, and can exert a stable pushing force on the abutting part 22.

[0151] In one embodiment, the wall thickness h1 of the abutting part 22 satisfies 1 mm ≤ h1 ≤ 6 mm, as Figure 17 shown.

[0152] Preferably, the wall thickness h1 of the abutting part 22 is any value between 1 mm and 6 mm, such as 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm, etc. Its specific value can be set according to needs and is not specifically limited herein.

[0153] It should be noted that: precisely by limiting the wall thickness range of the abutting part 22 as described above, it is possible to prevent the wall thickness of the abutting part 22 from being too thick and affecting the viewing field of the endoscope, and at the same time prevent the wall thickness of the abutting part 22 from being too thin and being prone to deformation, and being unable to exert a stable pushing effect on the implant. When the wall thickness of the abutting part 22 is within the above range, it will not affect the viewing field of the endoscope and also ensures the pushing effect of the abutting part.

[0154] More preferably, the preferred range of the wall thickness h1 of the abutting part 22 is between 2 mm and 5 mm, so as to achieve the best of the above effects.

[0155] In one embodiment, the abutting part 22 is made of a transparent high molecular silicone or rubber material.

[0156] Preferably, the abutting part 22 is made of a transparent high molecular silicone or rubber material, so that not only the situation of the catheter 11 passing through the abutting part 22 by the endoscope can be observed, but also a firm connection between the two can be realized through the interference fit with the pushing part 21, effectively preventing the two from separating.

[0157] In one embodiment, the roughness of the outer surface 2211 of the abutting portion 22 is less than that of its inner surface 2241. The roughness n1 of the outer surface 2211 of the abutting portion 22 satisfies 0.001um ≤ n1 ≤ 1.6um, and the roughness n2 of the inner surface 2241 of the abutting portion 22 satisfies 1.7um ≤ n2 ≤ 10um, as Figure 17 shown.

[0158] Preferably, the roughness n1 of the outer surface 2211 of the abutting portion 22 is any value between 0.001um and 1.6um. For example, it can be 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, 0.2um, 0.3um, 0.4um, 0.5um, 0.6um, 0.7um, 0.8um, 0.9um, 1um, 1.1um, 1.2um, 1.3um, 1.4um, 1.5um, 1.6um, etc. Its specific value can be set according to needs and is not specifically limited here.

[0159] It should be noted that: precisely the above limitation on the roughness of the outer surface 2211 of the abutting portion 22 effectively prevents the friction between the abutting portion 22 and the inner wall of the bronchus 3 during the implantation process, reduces the damage to the inner wall of the bronchus 3, and enables the implantation to be smoother, reducing the operation difficulty.

[0160] More preferably, the roughness n2 of the inner surface 2241 of the abutting portion 22 is any value between 1.7um and 10um. For example, it can be 1.7um, 1.8um, 1.9um, 2um, 3um, 4um, 5um, 6um, 7um, 8um, 9um, 10um, etc. Its specific value can be set according to needs and is not specifically limited here.

[0161] It should be noted that: precisely the above limitation on the range of the roughness of the inner surface 2241 of the abutting portion 22 increases the friction force with the pushing portion 21, makes the interference fit more stable, and effectively prevents the pushing portion 21 from detaching from the abutting portion 22 during use.

[0162] Even more preferably, the roughness of the outer surface of the abutting portion 22 is less than that of its inner surface. On the one hand, it reduces the friction force between the outer surface and the inner wall of the bronchus 3, enabling it to be smoothly implanted into the target position in the bronchus 3. On the other hand, it can enhance the stability of the connection with the pushing portion 21 and prevent the two from detaching.

[0163] In one embodiment, the difference between the inner diameter r6 of the pushing part 21 and the maximum outer diameter r7 of the catheter 11 satisfies r6 - r7 > 0.1 mm, as Figure 4 and Figure 13 shown.

[0164] Preferably, the range of r6 - r7 can be any value greater than 0.1 mm, such as 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, etc. The specific value can be set according to needs and will not be specifically limited herein.

[0165] More preferably, by defining the above range of r6 - r7, the gap between the outer surface of the catheter 11 and the inner surface of the pushing part 21 is ensured, so that the pushing part 21 can slide smoothly on the catheter 11.

[0166] It should be noted that: the range of r6 - r7 is preferably greater than 0.2 mm to optimize the above effect.

[0167] In one embodiment, the outer diameter r5 of the pushing part 21 and the maximum outer diameter r1 of the abutting part 22 satisfy r5 < r1, as Figure 12 and Figure 17 shown.

[0168] Preferably, the outer diameter r5 of the pushing part 21 is smaller than the maximum outer diameter r1 of the abutting part 22, so that the distal end of the pushing part 21 can extend into the interior of the abutting part 22, and the friction between the pushing part 21 and the inner wall of the bronchus 3 is reduced, and the damage to the inner wall of the bronchus 3 is reduced.

[0169] In one embodiment, the outer diameter r5 of the pushing part 21 and the inner diameter r4 of the first through hole 224 satisfy r5 - r4 > 0.1 mm, as Figure 12 and Figure 17 shown.

[0170] Preferably, r5 - r4 > 0.1 mm, so as to ensure the interference amount between the pushing part 21 and the abutting part 22, and significantly increase the connection stability between the pushing part 21 and the abutting part 22.

[0171] It should be noted that: r5 - r4 is preferably greater than 0.5 mm, so that the connection between the pushing part 21 and the abutting part 22 is more stable and the effect is more ideal.

[0172] In one embodiment, the wall thickness h2 of the pushing part 21 satisfies 0.1 mm ≤ h2 ≤ 0.5 mm, as Figure 13 shown.

[0173] Preferably, the wall thickness h2 of the pushing part 21 can be any value between 0.1 mm and 0.5 mm, such as 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, etc. The specific value can be set according to needs and will not be specifically limited herein.

[0174] It should be noted that: precisely the limitation of the wall thickness h2 of the pushing part 21 prevents the pushing part 21 from being easily bent due to too thin a wall thickness, and at the same time prevents the wall thickness of the pushing part 21 from being too thick, which affects the outer diameter of the pushing part 211 and is not conducive to operation in the narrow bronchus 3.

[0175] In one embodiment, the length L1 of the pushing part 21 and the length L2 of the catheter 11 satisfy 0.3L2 ≤ L1 ≤ 0.7L2, as Figure 13 shown.

[0176] Preferably, the length L1 of the pushing part 21 can be 0.3, 0.4, 0.5, 0.6, 0.7 times, etc. of the length L2 of the catheter 11. The specific multiple can be set according to needs and will not be specifically limited herein.

[0177] It should be noted that: precisely the limitation within the above range makes the length of the pushing part 21 less than the length of the catheter 11 to ensure that the distal end of the pushing part 21 reaches the orifice of channels such as the oral cavity and nasal cavity, and the proximal end of the catheter can extend from the pushing part 21. At the same time, the length of the pushing part 21 should not be too short to ensure the entire operation path.

[0178] More preferably, the preferred range of the length L1 of the pushing part 21 and the length L2 of the catheter 11 is: L1 is between 0.4L2 and 0.6L2 to achieve the optimal effect above.

[0179] In one embodiment, the length L1 of the pushing part 21 satisfies 0.4 m ≤ L1 ≤ 1.2 m, as Figure 13 shown.

[0180] Preferably, the length L of the pushing part 21 is any value between 0.4 m and 1.2 m, such as 0.4 m, 0.5 m, 0.6 m, 0.7 m, 0.8 m, 0.9 m, 1 m, 1.1 m, 1.2 m, etc. The specific value can be set according to needs and will not be specifically limited herein.

[0181] It should be noted that: precisely the limitation of the length of the pushing part 21 ensures that the entire operation path can be covered and the pushing requirement for the implant 4 is met.

[0182] In one embodiment, the pushing part 21 is made of a transparent polymer material.

[0183] Preferably, the pushing part 21 is made of a transparent polymer material, such as polyimide, polypropylene, polyethylene, polyether ether ketone, etc., so that not only can the internal situation be observed through the endoscope, but also it has a certain ability of passive bending, so as to be implanted into the curved part of the bronchus 3.

[0184] In one embodiment, the maximum outer diameter r7 of the catheter 11 satisfies r7 < 2 mm, as Figure 4 shown.

[0185] Preferably, the maximum outer diameter of the catheter 11 is any value less than 2 mm, such as 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, etc. Its specific value can be set according to needs and is not specifically limited here.

[0186] It should be noted that: it is precisely the above limitation on the maximum outer diameter of the catheter 11 that enables the implant 4 to be smoothly pushed on the catheter 11, and further enables the implant 4 to stably slide on the catheter 11, so as to move the implant 4 to the target position.

[0187] More preferably, the maximum outer diameter of the catheter 11 is preferably less than 1.5 mm, so that the catheter 11 can easily pass through the channel of the curved endoscope instrument and can be smoothly withdrawn from the central hole of the implant 4 without causing unnecessary interference or displacement to the implanted implant 4.

[0188] It should be noted that: during the pushing process, whether the pushing part 21 extends out of the endoscope channel or not does not affect the pushing effect of the implant 4.

[0189] In one embodiment, the radial supporting force f of the catheter 11 satisfies f > 5 N.

[0190] Preferably, the radial supporting force of the catheter 11 can be any value greater than 5 N, such as 5.1 N, 5.2 N, 5.3 N, 5.4 N, 5.5 N, 5.6 N, 5.7 N, 5.8 N, 5.9 N, 6 N, 7 N, 8 N, 9 N, 10 N, etc. Its specific value can be set according to needs and is not specifically limited here.

[0191] It should be noted that: it is precisely the above limitation on the radial supporting force of the catheter 11 that ensures that during the pushing process of the implant 4, the expansion fixing part 12 will not be displaced, so that the implant 4 can be smoothly implanted into the target position.

[0192] It should be further noted that: the radial supporting force of the catheter 11 is preferably greater than 7 N, which has a more significant supporting effect on the expansion fixing member 12 and is more conducive to the smooth implantation of the implant 4 into the target position.

[0193] In one embodiment, the minimum bending radius of the catheter 11 is less than 80 mm.

[0194] Preferably, the minimum bending radius of the catheter 11 is any value less than 80 mm, such as 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, etc. Its specific value can be set according to needs and will not be specifically limited here.

[0195] It should be noted that: precisely the above limitation on the minimum bending radius of the catheter 11 enables the present invention to adapt to the bending structure of the bronchus 3 without affecting the bending performance of the endoscope.

[0196] More preferably, the minimum bending radius of the catheter 11 is preferably less than 50 mm, so as to better adapt to the bending structure of the bronchus 3 and reduce the influence on the bending performance of the endoscope.

[0197] In one embodiment, the surface roughness of the outer surface of the catheter 11 is less than 0.1 μm.

[0198] Preferably, the surface roughness of the outer surface of the catheter 11 is any value less than 0.1 μm, such as 0.09 μm, 0.08 μm, 0.07 μm, 0.06 μm, 0.05 μm, 0.04 μm, 0.03 μm, 0.02 μm, 0.01 μm, etc. Its specific value can be set according to needs and will not be specifically limited here.

[0199] More preferably, precisely the above limitation on the surface roughness of the outer surface of the catheter 11 makes the outer surface smoother, reduces the damage to the inner wall of the bronchus 3, and makes it easier to be implanted into the bronchus 3.

[0200] More preferably, the surface roughness of different regions of the outer surface of the catheter 11 can be the same or different, etc. Its specific value can be set according to needs and will not be specifically limited here.

[0201] Still more preferably, the surface roughness of the distal end outer surface of the catheter 11 is less than that of the proximal end outer surface, so that the distal end outer surface of the catheter 11 is smoother. This not only reduces the damage to the inner wall of the bronchus 3 when the distal end of the catheter 11 is implanted into the bronchus 3, but also can be more conveniently guided into the bronchus 3, reducing the operation difficulty and improving the implantation efficiency.

[0202] More preferably, the roughness of the outer surface of the proximal end of the catheter 11 can be set to be relatively large, such as close to 0.1 um, so as to facilitate the user to hold it, increase the friction with the hand, and prevent it from falling off the hand during use.

[0203] In one embodiment, the length L2 of the catheter 11 satisfies L2 > 0.6 m.

[0204] Preferably, the length of the catheter 11 is the distance between its proximal end face and its distal end face, and it can be any value greater than 0.6 mm, such as 0.61 m, 0.62 m, 0.63 m, 0.64 m, 0.65 m, 0.66 m, 0.67 m, 0.68 m, 0.69 m, 0.7 m, 0.8 m, 0.9 m, 1 m, 2 m, etc. Its specific value can be set according to needs and will not be specifically limited here.

[0205] It should be noted that: precisely the above limitation on the length of the catheter 11 enables it to meet the implantation requirements of most people's lungs and leaves an operating space outside the body for removal from the endoscope.

[0206] More preferably, the length of the catheter 11 is preferably greater than 0.8 m, so as to be able to meet the implantation requirements of the vast majority of people, expand its scope of application, and reduce the use cost.

[0207] In one embodiment, the pushing part 21 includes a first part 2113 at the proximal end and a second part 2114 at the distal end, wherein: the outer diameter of the proximal end of the first part 2113 is smaller than the outer diameter of the distal end of the first part 2113; and / or, the hardness of the proximal end of the first part 2113 is less than the hardness of the distal end of the first part 2113, as Figure 21 shown.

[0208] Preferably, the second part 2114 is used to connect with the abutting part 22 and extend into the bronchus 3, so that the abutting part 22 can abut against the proximal end of the implant 4.

[0209] More preferably, a part of the first part 2113 extends into the bronchus 3, and the other part is outside the body, so that the operator can apply a pushing force to the first part 2113.

[0210] Still more preferably, a thinning part 215 is provided at the proximal end of the first part 2113, and the outer diameter of the thinning part 215 is smaller than the outer diameter of the distal end of the first part 2113, so that the proximal end of the first part 2113 is softer, and thus it is easier to extend out from the channel opening in the endoscope and convenient to pull it out from the endoscope.

[0211] More preferably, the length of the thinning portion 215 is preferably 40 mm. In other embodiments, other lengths may also be adopted, etc., and no specific limitation is made here.

[0212] Further preferably, a notch 213 is provided at the proximal end of the first portion 2113, thereby reducing the outer diameter of the proximal end of the first portion 2113 and making it smaller than the outer diameter of the distal end of the first portion 2113. Furthermore, the proximal end of the first portion 2113 is made softer, making it easier to extend from the channel opening in the endoscope and facilitating its pulling out from the endoscope.

[0213] Furthermore, the hardness of the proximal end of the first portion 2113 is less than that of its distal end, so that its proximal end has better bending performance and softness, making it easier to extend from the instrument channel opening of the endoscope and then pulling it out from the endoscope.

[0214] Still further, the proximal end of the first portion 2113 is preferably a catheter made of a polymer material with a small hardness, and is fixedly connected to the pushing portion 21 by adhesive bonding or thermal welding, making it softer and having better bending performance.

[0215] In one embodiment, the pushing portion 21 further includes a bending portion 214 connecting the first portion 2113 and the second portion 2114. Among them, in the natural state, the bending angle a of the bending portion 214 satisfies 5° ≤ a ≤ 70°; and / or, the bending radius of the bending portion 214 is greater than 1 mm; and / or. The distance h3 between the bending portion 214 and the distal end face of the pushing portion 21 satisfies 3 mm ≤ h3 ≤ 30 mm, as Figure 21 shown.

[0216] Preferably, the bending portion 214 is provided between the first portion 2113 and the second portion 2114. The distal end of the bending portion 214 is fixedly connected to the second portion 2114, and the proximal end of the bending portion 214 is fixedly connected to the first portion 2113, so that the first portion 2113 and the second portion 2114 are inclined to each other, meeting the implantation requirements of the bending part of the bronchus 3 and reducing the operation difficulty.

[0217] More preferably, in the natural state, the bending angle a of the bending portion 214 can be any value between 5° and 70°, such as 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, etc. Its specific value can be set according to needs and no specific limitation is made here.

[0218] It should be noted that: the natural state is the state when the pushing portion 21 is not stressed.

[0219] It should be further noted that: when the bending angle α of the bending portion 214 is less than 5°, the pushing requirement of the implant 4 cannot be satisfied, and when the bending angle α of the bending portion 214 is greater than 70°, the outer diameter of the bending portion 214 will be increased, affecting the effect of implanting into the bronchus 3.

[0220] More preferably, the bending angle α of the bending portion 214 is preferably any value between 10° and 60°, so that the above effects are optimized.

[0221] Also preferably, the bending radius of the bending portion 214 is any value greater than 1 mm, such as 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, etc., which can be set according to needs and are not specifically limited here.

[0222] It should be noted that: it is the above limitation on the bending radius of the bending portion 214 that prevents the outer diameter of the pushing portion 21 from increasing due to an overly small bending radius, which may cause the inability to implant into the bronchus 3 or increase the friction force with the inner wall of the bronchus 3.

[0223] Further preferably, the bending radius of the bending portion 214 is preferably greater than 3 mm, so that the above effects are optimized.

[0224] Furthermore, the distance h3 between the bending portion 214 and the distal end surface of the pushing portion 21 is the distance between the distal end surface of the bending portion 214 and the distal end surface of the pushing portion 21, which can be any value between 3 mm and 30 mm, such as 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, etc., and its specific value can be set according to needs and is not specifically limited here.

[0225] It should be noted that: it is the above limitation on the range of h3 that ensures that the distal end of the pushing portion 21 is parallel to the target bronchus, so that the implant 4 is in the expected position. When h3 is too large, the abutting portion 22 will hit the bronchial wall during the pushing process.

[0226] Still further, the distance h3 between the bending portion 214 and the distal end surface of the pushing portion 21 is preferably any value between 5 mm and 30 mm, so that the above effects are optimized.

[0227] In one embodiment, the catheter 11 is provided with a bending portion 111, and one or more bending portions 111 are provided. Wherein, in the natural state, the bending angle b of the bending portion 111 satisfies 5° ≤ b ≤ 70°; and / or, the bending radius of the bending portion 111 is greater than 1 mm; and / or. The distance h4 between the bending portion 111 and the distal end face of the catheter 11 satisfies 3 mm ≤ h4 ≤ 60 mm, as Figure 9 shown.

[0228] Preferably, the bending portion 111 is disposed on the catheter 11 so that it is bent, and it can be bent in one plane or in different planes, and it can be set as required without specific limitation herein.

[0229] More preferably, one or more bending portions 111 can be provided, etc., without specific limitation herein.

[0230] It should be noted that: when multiple bending portions 111 are provided, the multiple bending portions 111 can be bent in the same direction or in different directions, etc.; at the same time, the multiple bending portions 111 can be provided at the distal end of the catheter 11, or at the proximal end of the catheter 11, or at both the distal end and the proximal end of the catheter 11, etc.; and, the multiple bending portions 111 can be in one plane or not in one plane, etc. It can be set as required without specific limitation herein.

[0231] Still more preferably, the bending angle b of the bending portion 111 is the included angle between the extending directions of its two ends, and this included angle b can be 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, etc. Its specific value can be set as required without specific limitation herein.

[0232] It should be noted that: the above natural state is the state when the catheter 11 is not stressed.

[0233] It should be noted that; it is precisely the limitation of the range of the included angle b that enables the implantation requirements of the bronchus 3 at different angles to be met, significantly expanding the scope of use of the present invention.

[0234] Also preferably, the bending angle b of the bending portion 111 is preferably 10° to 60°, so as to meet the requirements for implanting the implant 4 into the majority of bronchi.

[0235] It should be noted that: when the angle of the included angle b is less than 5°, the present invention cannot meet the implant delivery requirements; when the angle of the included angle b is greater than 70°, the outer diameter of the catheter in the bent part will be significantly increased, which will affect the result of implant delivery, increase the patient's pain and reduce the surgical success rate.

[0236] Further preferably, the bending radius of the bending portion 111 is greater than 1 mm, for example, it can be 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, etc., and the user can set it according to needs, and no specific limitation is made here.

[0237] It should be noted that: when the bending radius of the bending portion 111 is less than or equal to 1 mm, it will cause the outer diameter of the catheter 11 to increase, affecting the effect of implanting into the bronchus 3. Therefore, by limiting the bending radius range of the bending portion 111 as described above, the outer diameter of the bending portion 111 is significantly reduced, so that the distal end of the catheter 11 can be smoothly implanted into the bronchus 3.

[0238] Furthermore, the bending radius of the bending portion 111 is preferably greater than 2 mm, so as to meet the needs of implanting the implant 4 into most bronchi 3, with a wide range of use and remarkable effects.

[0239] Furthermore, the distance h4 between the bending portion 111 and the distal end surface of the catheter 11 is the distance between the distal end surface of the bending portion 111 and the distal end surface of the catheter 11. As Figure 4 shown, the distance h4 is any value between 3 mm and 60 mm, for example, it can be 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, etc., and its specific value can be set according to needs, and no specific limitation is made here.

[0240] It should be noted that: precisely the above limitation of h4 enables the present invention to be implanted in a deeper position, thereby expanding the implantation range, and the anchoring effect is more firm, which is more conducive to the implant 4 being implanted along the catheter 11.

[0241] Still further, the distance h4 is preferably any value between 5 mm and 30 mm, so as to meet the needs of most deep implantations, and significantly enhance the anchoring force, so that the distal end of the catheter 11 can be stably fixed in the bronchus 3.

[0242] In an embodiment, a marking portion is provided on the outer surface of the inner side of the bending portion 111.

[0243] Preferably, the marking portion is provided on the outer surface of the inner side of the bending portion 111, and it can be a marking recognizable under an endoscope, such as a line, a pattern, a color, etc., or a marking recognizable by a detection device, such as a rough surface with a roughness of 10 um to 40 um detectable by ultrasound, or a developing marking detectable by X-ray, etc., and it can be selected and set according to needs, and no specific limitation is made here.

[0244] More preferably, when the identification part is a rough surface, the surface roughness of the inner side of the bending part 111 in the bending direction is greater than that of other areas, so that its accurate position and direction can be obtained by ultrasound, which is conducive to understanding the implantation depth and bending direction of the bending part 111, and is convenient for the user to operate.

[0245] More preferably, the roughness of the rough surface can be 10um, 11um, 12um, 13um, 14um, 15um, 16um, 17um, 18um, 19um, 20um, 25um, 30um, 35um, 40um, etc. The specific value can be set according to needs and is not specifically limited here.

[0246] It should be noted that: precisely the above limitation on the surface roughness of the inner side of the bending part 111 in the bending direction not only facilitates obtaining the bending position but also the bending direction, which is conducive to ensuring the accuracy and success rate of the operation.

[0247] In one embodiment, the bending part 214 is in a polygonal shape or a curved shape; and / or, the bending part 111 is in a polygonal shape or a curved shape, such as Figure 9 and Figure 21 shown.

[0248] Preferably, the bending part 214 is in a polygonal shape, so that it is convenient for processing and manufacturing while meeting the implantation and anchoring requirements of the bending part in the bronchus 3, making the structure more simplified.

[0249] More preferably, the bending part 214 is in a curved shape, so that the pushing part 21 can better pass through the curved bronchus 3, reducing the damage to the inner wall of the bronchus 3.

[0250] Still more preferably, the bending part 111 is in a polygonal shape, so as to meet the implantation and anchoring requirements of the bending part in the bronchus 3 and be convenient for processing and manufacturing, making the structure more simplified.

[0251] Also preferably, the bending part 111 is in a curved shape, so that the catheter 11 can better pass through the curved part in the bronchus 3, reducing the damage to the bronchus 3 and being safer.

[0252] In one embodiment, the expansion fixing part 12 is in a curved shape, such as Figure 5 shown.

[0253] Preferably, the expansion fixing part 12 can be partially curved or entirely curved. When the expansion fixing part is partially curved, the curved part can be arranged at the proximal end, distal end or middle part of the expansion fixing part 12, etc. It can be set according to needs and is not specifically limited here.

[0254] More preferably, when a part of the expansion fastener 12 is bent, the length of the bent part can be one tenth, one ninth, one eighth, one seventh, one sixth, one fifth, one fourth, one third, one half, etc. of the expansion fastener 12, which can be set as needed and will not be specifically limited herein.

[0255] More preferably, when the entire expansion fastener 12 is bent, it can meet the needs of the bronchus with a larger length, significantly expanding its scope of use.

[0256] In one embodiment, the roughness of the outer surface of the inner side of the bent portion 111 is greater than that of other regions, and is any value between 10um and 40um, such as Figure 4 shown.

[0257] Preferably, the roughness of the outer surface of the inner side of the bent portion 111 is greater than that of other regions, so that its accurate position and direction can be obtained under ultrasonic display, which is beneficial to understanding the implantation depth and bending direction of the bent portion 111, and thus facilitates the operation of the user.

[0258] More preferably, the roughness of the outer surface of the inner side of the bent portion 111 can be any value between 10um and 40um, such as 10um, 11um, 12um, 13um, 14um, 15um, 16um, 17um, 18um, 19um, 20um, 25um, 30um, 35um, 40um, etc. Its specific value can be set as needed and will not be specifically limited herein.

[0259] It should be noted that: precisely the above limitation on the roughness of the outer surface of the inner side of the bent portion 111 not only facilitates obtaining its position and bending direction through ultrasonic display, but also facilitates production and processing, improving the convenience of operation.

[0260] In one embodiment, a handle 24 is provided at the proximal end of the pushing portion 21, such as Figure 22 shown.

[0261] Preferably, the handle 24 can be in the shape of a cylinder, or can be a cuboid or other geometric bodies, etc., which will not be specifically limited herein.

[0262] More preferably, the handle 24 is sleeved on the proximal end of the pushing portion 21 and fixedly connected thereto, such as by bonding, hot melting, welding or integral molding, etc., which will not be specifically limited herein.

[0263] More preferably, the friction coefficient of the outer peripheral surface of the handle 24 is relatively large, so as to increase the friction force with the operator's hand and effectively prevent it from slipping out of the operator's hand.

[0264] In one embodiment, a developer 13 is provided at at least one end of the expansion fastener 12, such as Figure 6 as shown.

[0265] Preferably, the developer 13 is provided at one end of the expansion fastener 12, and may also be provided at both ends of the expansion fastener 12, etc., which can be set according to needs and will not be specifically limited herein.

[0266] More preferably, the developer 13 can be in an annular shape, or in an arc shape, etc., which can be set by the user according to needs and will not be specifically limited herein.

[0267] Still more preferably, the developer 13 can be made of conventional developer materials, etc., which can be set by the user according to needs and will not be specifically limited herein.

[0268] It should be noted that: by providing the developer 13, the position of the expansion fastener 12 can be judged through imaging.

[0269] In one embodiment, as Figure 7 shown, when the catheter 11 and the expansion fastener 12 are bundled and fixedly connected through the wire 14, the wire 14 on both sides of the expansion fastener 12 can be used to bundle and fix the catheter 11, making the fixation more stable.

[0270] In one embodiment, the outer surface of the catheter 11 is provided with scales, such as Figure 8 shown.

[0271] Preferably, the outer surface of the catheter 11 is provided with scales, so that the position of the distal end of the catheter 11 can be determined through an endoscope, and how far it is from the target position in the bronchus 3, thus facilitating daily use and improving the convenience of use.

[0272] More preferably, the scales extend axially along the catheter 11 from its proximal end towards the distal end, so that it is convenient to directly determine the position of the distal end of the catheter 11 from the part of the catheter 11 outside the body, with simple operation and convenient use.

[0273] Still more preferably, the scales can be in millimeters, centimeters, decimeters, etc., which can be set according to needs and will not be specifically limited herein.

[0274] Also preferably, the starting end of the scales can start from the expansion fastener 12, or from the distal end face of the catheter 11, etc., and will not be specifically limited herein.

Claims

1. A delivery device for an implant, characterized in that, It includes a guiding structure and a pusher. The guiding structure includes a catheter and an expansion fixing member. One end of the catheter communicates with the expansion fixing member and the other end extends out of the patient's body. The expansion fixing member is used to extend into the bronchus and be fixed in the bronchus when inflated with fluid. The catheter is used to pass through the inside of the pusher and the implant respectively. The distal end of the pusher abuts against the proximal end of the implant, so that the pusher pushes the implant to slide along the catheter to the target position in the bronchus.

2. The delivery device for the implant according to claim 1, characterized in that The pusher is a push tube, and the distal end of the push tube abuts against the proximal end of the implant.

3. The delivery device of the implant according to claim 2, characterized in that, The distal end of the push tube is in the shape of a cone, a sphere or a cylinder.

4. The delivery device of the implant according to claim 1, wherein The pusher includes a pushing part and an abutting part arranged at the distal end of the pushing part. The distal end of the pushing part is fixedly connected to the proximal end of the abutting part, and the distal end of the abutting part abuts against the proximal end of the implant.

5. The delivery device of the implant according to claim 4, characterized in that, The distal end of the abutting part is hemispherical; and / or, The proximal end of the abutting part is conical, and in the direction from the distal end to the proximal end, the diameter of the proximal end of the abutting part gradually decreases; and / or, The outer diameter of the middle part of the abutting part is larger than the outer diameters of its proximal end and distal end.

6. The delivery device of the implant according to claim 4, characterized in that The abutting part is conical.

7. The delivery device of the implant according to claim 4, characterized in that, The abutting part is provided with a first through hole, and the distal end of the pushing part extends into the first through hole and is in interference fit with the abutting part.

8. The delivery device of the implant according to claim 4 or 7, characterized in that an adhesive is provided between the distal end of the pushing part and the abutting part.

9. The delivery device of the implant according to claim 4, characterized in that, The distance t between the distal end face of the abutting part and the distal end face of the pushing part satisfies 0.1mm ≤ t ≤ 6mm; and / or, The abutting part includes an inner part close to the central axis and an outer part away from the central axis. The hardness y1 of the inner part satisfies 20A ≤ y1 ≤ 50A, and the hardness y2 of the outer part satisfies y2 < 30A. The hardness of the inner part is greater than that of the outer part; and / or, The maximum outer diameter r1 of the abutting part satisfies 2mm ≤ r1 ≤ 6mm; and / or, The implant includes a second through hole, the catheter passes through the second through hole, and the maximum outer diameter r1 of the abutting part, the inner diameter r2 of the second through hole and the maximum outer diameter r3 of the implant satisfy r2 < r1 < r3.

10. The delivery device of the implant according to claim 7, characterized in that, The inner diameter r4 of the first through hole satisfies 1mm ≤ r4 ≤ 3mm, and the outer diameter r5 of the pushing part satisfies 2mm ≤ r5 ≤ 4mm; and / or, The wall thickness h1 of the abutting part satisfies 1mm ≤ h1 ≤ 6mm; and / or, The abutting part is made of a transparent high molecular silicone or rubber material; and / or, The surface roughness of the outer surface of the abutting part is less than that of its inner surface. The surface roughness n1 of the outer surface of the abutting part satisfies 0.001um ≤ n1 ≤ 1.6um, and the surface roughness n2 of the inner surface of the abutting part satisfies 1.7um ≤ n2 ≤ 10um.

11. The delivery device of the implant according to claim 7, characterized in that, The difference between the inner diameter r6 of the pushing part and the maximum outer diameter r7 of the catheter satisfies r6 - r7 > 0.1mm; and / or, The outer diameter r5 of the pushing part and the maximum outer diameter r1 of the abutting part satisfy r5 < r1; and / or, The outer diameter r5 of the pushing part and the inner diameter r4 of the first through hole satisfy r5 - r4 > 0.1 mm; and / or, The wall thickness h2 of the pushing part satisfies 0.1 mm ≤ h2 ≤ 0.5 mm; and / or, The length L1 of the pushing part and the length L2 of the catheter satisfy 0.3L2 ≤ L1 ≤ 0.7L2; and / or, The length L1 of the pushing part satisfies 0.4 m ≤ L1 ≤ 1.2 m; and / or, The pushing part is made of a transparent polymer material.

12. The delivery device for the implant according to claim 1, characterized in that, The maximum outer diameter r7 of the catheter satisfies r7 < 2 mm; and / or, The radial support force f of the catheter satisfies f > 5 N; and / or, The minimum bending radius of the catheter is less than 80 mm; and / or, The surface roughness of the outer surface of the catheter is less than 0.1 um; and / or, The length L2 of the catheter satisfies L2 > 0.6 m.

13. The delivery device of the implant according to claim 4, wherein, The pushing part includes a first part at the proximal end and a second part at the distal end, where: The outer diameter of the proximal end of the first part is smaller than the outer diameter of the distal end of the first part; and / or, The hardness of the proximal end of the first part is less than the hardness of the distal end of the first part.

14. The delivery device of the implant according to claim 13, characterized in that, The pushing part further includes a bending part connecting the first part and the second part, where, In the natural state, the bending angle a of the bending part satisfies 5° ≤ a ≤ 70°; and / or, The bending radius of the bending part is greater than 1 mm; and / or. The distance h3 between the bending part and the distal end face of the pushing part satisfies 3 mm ≤ h3 ≤ 30 mm.

15. The delivery device of the implant according to claim 14, characterized in that, The catheter is provided with a bending part, and there is one or more bending parts, where, In the natural state, the bending angle b of the bending part satisfies 5° ≤ b ≤ 70°; and / or, The bending radius of the bending part is greater than 1 mm; and / or. The distance h4 between the bending part and the distal end face of the catheter satisfies 3 mm ≤ h4 ≤ 60 mm.

16. The delivery device of the implant according to claim 15, characterized in that, The bending part is in a polygonal shape or a curved shape; and / or, The bending part is in a polygonal shape or a curved shape.

17. The delivery device of the implant according to claim 1, characterized in that The expansion fixing part is in a curved shape.

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