Implants, delivery mechanisms, lung volume reduction implant devices and systems

Abstract

The application relates to an implant, a conveying mechanism, a lung volume reduction implant device and system, the lung volume reduction implant device comprising an implant and a conveying mechanism, the conveying mechanism being arranged to controllably release or recover the implant; the implant comprising a proximal end, a distal end and an intermediate section, the intermediate section being capable of being deformed between a coiled shape and a straightened shape; the conveying mechanism comprising a pushing part and a first connecting part connected with the pushing part, the first connecting part being detachably connected with the proximal end. The application can block the bronchus, the contraction stress area of the implant is complete, and the success rate of the lung volume reduction surgery is effectively improved. A plurality of implants do not need to be implanted, and the burden on the patient is further reduced. The implant and the conveying mechanism are detachably connected, the implant can be loosened in situ, the implant does not need to be pushed forward, and precise release is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional therapy, in particular to an implant, a delivery mechanism, a lung volume reduction implant device and a system. BACKGROUND

[0002] In clinical treatment, emphysema is a common lung disease, especially in the elderly. According to statistics, the 5-year survival rate of patients with end-stage emphysema is less than 50%.

[0003] Traditional emphysema internal medicine treatment often uses oxygen inhalation, prevention of lung infection, bronchial spasmolysis and other means, but the above-mentioned means has very limited treatment effect.

[0004] And the surgical treatment of emphysema is mainly lung volume reduction surgery, but there are still many limitations, which cannot achieve the expected effect. The limitations mainly include strict surgical selection criteria, anesthesia and anesthesia-related complications, and the preoperative treatment effect is difficult to predict, and the postoperative treatment effect is poor due to excessive or insufficient resection. And some patients have poor lung function and often cannot tolerate surgery, so the postoperative mortality is high, which further limits the application in surgical operation. At the same time, the high cost of surgery, the great mental and physical pain, all of which have brought great pressure to the patients.

[0005] Lung volume reduction surgery (LVRS) is a method of achieving lung volume reduction through bronchoscopy using different methods, including one-way flap, coil placement, bypass ventilation, biological glue occlusion, and hot steam ablation.

[0006] Among them, if the one-way flap has poor clinical indicators, the residual gas and sputum in the target area cannot be effectively and actively discharged, and the accuracy of placement to different anatomical structures is limited, which affects the effectiveness of treatment and has high technical difficulty. Artificial bronchial bypass surgery does not significantly improve postoperative lung function and quality of life scores. Biological glue occlusion completely occludes the emphysema area, which can cause postoperative inflammation. Hot steam ablation destroys the original tissue structure of the emphysema area, which is easy to cause postoperative inflammation.

[0007] In related technologies, as shown in Figure 1 A lung volume reduction coil is used to treat emphysema. The lung volume reduction coil is a spring coil made of nickel-titanium memory alloy, which is released after entering the target area. The lung volume reduction coil naturally curls into a memory shape, pulling the corresponding lung tissue to fold and compress, achieving the purpose of lung volume reduction.

[0008] However, the existing lung volume reduction coil contraction stress area is not complete, and it is easy to cause problems such as not clamping the bronchus, resulting in failure of the lung volume reduction surgery. In complex conditions, multiple coils need to be implanted, greatly increasing the burden on patients. SUMMARY

[0009] The present application provides an implant, a delivery mechanism, a lung volume reduction implant device and system, which can clamp the bronchus, make the contraction stress area of the implant complete, and effectively improve the success rate of the lung volume reduction surgery. Moreover, multiple implants do not need to be implanted, further reducing the burden on patients.

[0010] In a first aspect, the present application provides a lung volume reduction implant device, comprising an implant and a delivery mechanism, the delivery mechanism being configured to controllably release the implant;

[0011] The implant comprises a proximal end, a distal end and an intermediate segment, the intermediate segment being capable of deforming between a coiled shape and a straightened shape; the delivery mechanism comprises a pushing portion and a first connecting portion connected with the pushing portion, and the first connecting portion is detachably connected with the proximal end.

[0012] In a possible implementation, the intermediate segment is one of the following: a spiral body comprising at least one turn, a planar volute spring structure, and a bent structure.

[0013] In a possible implementation, the rigidity of the proximal end and / or the distal end is smaller than the rigidity of the intermediate segment.

[0014] In a possible implementation, the distal end comprises an inner core layer and / or an outer core layer, and the rigidity of the outer core layer is smaller than the rigidity of the inner core layer.

[0015] In a possible implementation, the outer core layer is in a cylindrical shape to cover the inner core layer; or the outer core layer is in a spring shape and wound on the inner core layer.

[0016] In a possible implementation, the distal end is provided with a smooth body.

[0017] In a possible implementation, the distal end comprises a distal straight segment and a bent segment, the bent segment being connected with the intermediate segment through the distal straight segment; wherein the bent segment and the distal straight segment have a preset included angle therebetween.

[0018] In a possible implementation, the distal end is provided with a developing marker, and the developing marker is formed by winding a wire body into a spring shape.

[0019] In a possible implementation, the proximal end part comprises a flexible segment and a second connecting part arranged at the flexible segment, the flexible segment is connected with the intermediate segment, and the second connecting part is detachably connected with the first connecting part; wherein the second connecting part is in the shape of a rugby ball or a hollow column.

[0020] In a possible implementation, an end of the flexible segment away from the intermediate segment is provided with an adapter segment and a support segment, the support segment is connected with the flexible segment through the adapter segment; the support segment is embeddedly connected with the second connecting part, and the second connecting part is threadedly connected with the first connecting part.

[0021] In a possible implementation, an outer diameter size of the adapter segment is smaller than an outer diameter size of the support segment, the outer diameter size of the support segment is smaller than an inner diameter size of the second connecting part, and the outer diameter size of the support segment is smaller than or equal to an outer diameter size of the intermediate segment or the flexible segment.

[0022] In a possible implementation, the proximal end part further comprises a proximal straight segment, and the flexible segment is connected with the intermediate segment through the proximal straight segment.

[0023] In a possible implementation, the first connecting part comprises a plurality of clamping bodies, and a clamping space is arranged between the plurality of clamping bodies and configured to clamp the implant; wherein one end of the clamping body is fixedly connected with the pushing part, and the plurality of clamping bodies are arranged to be capable of relative movement to open or close the clamping space.

[0024] In a possible implementation, the clamping body comprises an elastic segment, a rigid segment and a semicircular arc segment connected in sequence; wherein the elastic segment is connected to the pushing part.

[0025] In a possible implementation, the pushing part comprises a support steel cable and a guide tube, the support steel cable is fixedly connected with the clamping body, and the guide tube is sleeved outside the support steel cable; wherein the guide tube and the support steel cable have a first relative position and a second relative position; when the guide tube is located at the first relative position, the guide tube is located outside the implant, and the guide tube is arranged to constrain the clamping body to close the clamping space; when the guide tube is located at the second relative position, the guide tube is located outside the support steel cable, and the guide tube is arranged to withdraw from the clamping body to open the clamping space and controllably release the implant.

[0026] In a possible implementation, a high-contrast mark is arranged at a side of the guide tube away from the proximal end part.

[0027] In one possible implementation, a marking line is provided on the side of the support cable away from the proximal end.

[0028] Secondly, this application provides an implant that cooperates with the delivery mechanism of a lung volume reduction implantation device. The implant includes a proximal end, a distal end, and an intermediate segment. The intermediate segment is deformable between a coiled shape and a straightened shape. The proximal end is detachably connected to the delivery mechanism, and the distal end abuts against the inner wall of the bronchus. The distal end includes an inner core layer and / or an outer core layer.

[0029] Thirdly, this application provides a delivery mechanism that cooperates with the implant of a lung volume reduction implantation device. The delivery mechanism includes a pushing part and a first connecting part connected to the pushing part, the first connecting part being detachably connected to the implant. The delivery mechanism is configured to controllably release the implant.

[0030] Fourthly, this application provides a lung volume reduction implantation system, including a monitoring module, a bronchoscope, and a lung volume reduction implantation device as described in the first aspect; the bronchoscope is connected to the monitoring module, and the lung volume reduction implantation device is installed on the bronchoscope.

[0031] The technical solutions provided in this application have the following advantages compared with the prior art:

[0032] The implant, delivery mechanism, lung volume reduction implantation device and system provided in this application embodiment can clamp the bronchus, causing it to contract and concentrate at the center of the spring-like structure, effectively improving the success rate of lung volume reduction surgery. Furthermore, it eliminates the need for multiple implants, further reducing the burden on patients. The implant and delivery mechanism are detachably connected, allowing for in-situ release of the implant without the need for forward pushing, achieving precise release. Attached Figure Description

[0033] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0034] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0035] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0036] Figure 1 A structure diagram of a lung volume reduction coil in the related art;

[0037] Figure 2 A structure diagram of an implant provided by an embodiment of the present application;

[0038] Figure 3 A structure diagram of an implant provided by an embodiment of the present application;

[0039] Figure 4 A structure diagram of an implant provided by an embodiment of the present application;

[0040] Figure 5 A structure diagram of an implant provided by an embodiment of the present application;

[0041] Figure 6 A structure diagram of a proximal straight section provided by an embodiment of the present application;

[0042] Figure 7 A structure diagram of a distal end provided by an embodiment of the present application; Figure 2 A cross-sectional structure diagram of the distal end shown in FIG. 9B;

[0043] Figure 8 A structure diagram of a distal end provided by an embodiment of the present application;

[0044] Figure 9 A structure diagram of a distal end provided by an embodiment of the present application;

[0045] Figure 10 A structure diagram of a distal end provided by an embodiment of the present application;

[0046] Figure 11 A structure diagram of a distal end provided by an embodiment of the present application;

[0047] Figure 12 A structure diagram of a distal end provided by an embodiment of the present application;

[0048] Figure 13 A structure diagram of a distal end provided by an embodiment of the present application;

[0049] Figure 14 A structure diagram of a distal end provided by an embodiment of the present application;

[0050] Figure 15 A cross-sectional structure diagram of the distal end shown in FIG. 11B; Figure 14 A cross-sectional structure diagram of the distal end shown in FIG. 12B;

[0051] Figure 16 A structure diagram of a proximal end provided by an embodiment of the present application;

[0052] Figure 17 This is a schematic diagram of the structure of a lung volume reduction implantation device provided in an embodiment of this application;

[0053] Figure 18 This is a schematic diagram of the structure of a lung volume reduction implantation device provided in an embodiment of this application;

[0054] Figure 19 This is a schematic diagram of the structure of a first connecting part provided in an embodiment of this application;

[0055] Figure 20 This is a schematic diagram of the structure of a first connecting part provided in an embodiment of this application;

[0056] Figure 21 This is a schematic diagram of the structure of a lung volume reduction implantation device provided in an embodiment of this application;

[0057] Figure 22 This is a schematic diagram of the structure of a lung volume reduction implantation device provided in an embodiment of this application;

[0058] Figure 23 This is a schematic diagram of the structure of an implant provided in an embodiment of this application;

[0059] Figure 24 This is a schematic diagram of the structure of an implant provided in an embodiment of this application;

[0060] Figure 25 This is a schematic diagram of a lung volume reduction implantation system provided in an embodiment of this application.

[0061] Explanation of reference numerals in the attached figures:

[0062] 1. Implant; 11. Proximal end; 111. Flexible segment; 112. Second connector; 113. Support segment; 114. Transition segment; 115. Proximal straight segment; 12. Intermediate segment; 13. Distal end; 131. Inner core layer; 132. Outer core layer; 133. Smooth body; 134. Bending segment; 135. Distal straight segment;

[0063] 2. Conveying mechanism; 21. Pushing part; 211. Supporting steel cable; 212. Conduit; 213. Marking line; 2131. First marking line; 2132. Second marking line; 22. First connecting part; 221. Clamping body; 2211. Elastic section; 2212. Rigid section; 2213. Semi-circular arc section; 222. Clamping space;

[0064] 3. Monitoring module; 31. First monitor; 32. Remote imaging capture device; 33. Second monitor; 4. Bronchoscope; E. Bronchus. Detailed Implementation

[0065] In order to make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the following will be combined with the accompanying drawings for the embodiments of the present application to make a clear and complete description of the technical solutions in the embodiments of the present application. Obviously, the described embodiments are a part rather than all of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work belong to the scope of protection of the present application.

[0066] The following disclosure provides many different embodiments, or examples, for implementing different structures of the present application. For the purpose of simplicity, the elements and settings of particular examples in the following description will be described with reference to specific arrangements. These are by no means limiting and are only used to illustrate the present application. Furthermore, the present application can refer to the same or similar reference numerals in different examples. Such repetition is for the purpose of simplicity and clarity and does not indicate a relationship between the various embodiments and / or settings discussed.

[0067] For the purpose of description, spatial relative terms can be used in the description to describe the relative position relationship or movement of one element or feature with respect to another element or feature as shown in the drawings, such as "internal", "external", "inboard", "outboard", "under", "below", "on", "above", "front", "back", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device in the drawings is flipped over or the posture is changed or the movement state is changed, the directional indications will also change accordingly, for example: the element described as "under" or "below" another element or feature will be oriented as "above" or "above" another element or feature. Therefore, the example term "below" can include both the up and down positions. The device can be additionally oriented (rotated 90 degrees or in other directions) and the spatial relative relationship description used in the text is interpreted accordingly.

[0068] In order to solve the technical problems that the shrinkage force of the lung volume reduction coil is not concentrated, it is easy to cause the bronchus to be not blocked, and a plurality of coils need to be implanted, greatly increasing the burden of the patient in the related art, the present application provides a lung volume reduction implant device. The implant body can block the bronchus, so that the shrinkage force area of the implant body is complete, and the success rate of the lung volume reduction surgery is effectively improved. And no multiple implant bodies need to be implanted, further reducing the burden of the patient. The implant body and the delivery mechanism are detachably connected, the implant body can be loosened in situ, the implant body does not need to be pushed forward, and precise release is achieved.

[0069] In some example embodiments, as Figure 2 , Figure 17 ,Figure 18 As shown in the figure, a lung volume reduction implant device includes an implant body 1 and a delivery mechanism 2, the implant body 1 and the delivery mechanism 2 are detachably connected, the delivery mechanism 2 is used to deliver the implant body 1 into the bronchus E and controllably release the implant body 1 to perform interventional therapy. Among them, the implant body 1 and the delivery mechanism 2 can be pre-assembled, or they can be placed separately, and then assembled when implantation is needed.

[0070] In the related art, the lung volume reduction coil is placed into the bronchus, and when it releases the lung volume reduction coil, it pushes the lung volume reduction coil forward and pushes it out from the sheath to achieve separation, so that the lung volume reduction coil will jump forward and cause displacement at the moment it comes out of the sheath, the release position is not accurate enough, and the operation effect is affected. The implant body 1 and the delivery mechanism 2 in the present application are detachably connected, the implant body 1 is loosened in situ, and the implant body 1 does not need to be pushed forward, so that precise release is achieved.

[0071] The implant body 1 includes a proximal end portion 11, an intermediate section 12 and a distal end portion 13 arranged in sequence, which can be an integral structure to make the overall structure of the implant body 1 more reliable, or can be a split structure, produced separately and assembled and fixedly connected together to reduce production difficulty.

[0072] Among them, the proximal end portion 11 refers to the end close to the operator, and the distal end portion 13 is the end sent into the bronchus E (see Figures 23-25 The figure).

[0073] The intermediate section 12 can be deformed between a coiled shape and a straightened shape, and under the action of an external force, the intermediate section 12 is straightened before being sent into the bronchus E, and when it is sent to the target position, the intermediate section 12 can recover to the initial state and become coiled, so that the bronchus E is folded, compressed, etc., to achieve the purpose of lung volume reduction.

[0074] The intermediate section 12 will be further exemplarily described below to better understand the technical solutions in the present application.

[0075] First example

[0076] As shown in Figure 2 , Figure 3 , Figure 17 The intermediate section 12 is a spiral body. The spiral spring structure is adopted, the surface is smooth and has no sharp edges and corners, which avoids damage to the bronchus E and improves the safety factor during lung volume reduction.

[0077] It should be noted that the above spiral body can be one turn, two turns, three turns, etc., and the number of turns of the spiral body can be set according to the area to be treated of the bronchus E, and the actual situation is used as the criterion.

[0078] The helix is made of a material with good elasticity and biocompatibility, so as to better restore to the original state and not cause harm to the human body. The material can be SUS316L, nickel-titanium alloy, cobalt-chromium alloy, etc.

[0079] The lung volume reduction coil in the related art is an irregular three-dimensional structure, and the contraction force is dispersed and not concentrated from the straightened state to the contracted state. If sufficient contraction force is needed to squeeze the tissue, the linear direction cross section needs to be large (i.e. the cross section perpendicular to the axial direction after straightening). When the lung volume reduction coil is delivered, a larger catheter of about 5Fr to 9Fr is needed. It is difficult to implant the lung volume reduction coil into the lung bypass or the end of some small-diameter airways through the catheter, and the range of the emphysema area squeezed and pulled by the lung volume reduction coil is limited, which affects the volume reduction effect.

[0080] The helix in the present application is coiled, and the pitch p of the helix can be equal or not equal when the helix has multiple turns. The pitch p can be 0mm-11mm. If the pitch P is too large, the implant 1 cannot achieve a good lung volume reduction effect. Under the condition that other parameters are the same, the smaller the pitch P, the better the coiling force it produces. The pitch p of the helix on both sides of the middle section 12 is smaller than the pitch p of the helix in the middle of the middle section 12, so that it has a good restoring force and a good restoring speed.

[0081] The helix is coiled, and the outer diameter D4 of the helix can be equal or not equal. The outer diameter D4 can be 3mm-25.0mm, and preferably 16mm-20.0mm. If the outer diameter D4 is too small, the helix cannot be clamped in the bronchus E, and thus cannot be coiled. If the outer diameter D4 is too large, it will cause too much force on the bronchus E, which can easily damage the bronchus E, and the outer diameter D4 is too large, which causes the length of the implant 1 after straightening to be too long, which can easily extend to the normal lung, thereby causing the normal lung tissue to be coiled, which affects the normal function of the lung. The outer diameter D4 of the helix on both sides of the middle section 12 is smaller than the outer diameter D4 of the helix in the middle of the middle section 12. Since the spring has the characteristic that the smaller the outer diameter, the greater the elastic force under the same pitch, the lung volume reduction return force coil in the present application has a greater contraction force from both sides to the middle, so that it has a good restoring force and a good restoring speed.

[0082] When the helix in the present application is straightened, refer to Figure 18As shown, the length L is 100mm-200mm. If the size is too short, it cannot shrink enough lung tissue, and if the size is too long, it is easy to extend to normal lung tissue, thereby causing the normal lung tissue to curl and affecting the normal function of the lung. At the same time, if the size is too long, it also exceeds the total length of the bronchus E, and cannot be applied in clinical practice, and cannot achieve the purpose of interventional therapy.

[0083] The helix in the present application is straight, and the entire linear cross-sectional size can be the same or different. When the cross section of the helix is circular, the outer diameter d1 can be, for example, 0.50mm-0.70mm, preferably 0.6mm-0.65mm. Among them, the cross-sectional size of the helix on both sides of the middle section 12 is greater than that of the helix in the middle of the middle section 12, and the greater the cross-sectional size, the greater the shrinkage force, so that it has better recovery force and recovery speed.

[0084] The helix in the present application is designed reasonably, and compared with the dispersion of shrinkage force in the prior art, the shrinkage force is concentrated at the center position of the spring, and the smaller force can achieve the shrinkage effect of the prior art. It can be made of smaller diameter material, that is, the cross section is smaller after being straightened, so that it does not need a larger catheter 212 to cooperate, and can shrink enough lung tissue to ensure the effect of volume reduction.

[0085] Second example

[0086] As shown in Figure 4 , the middle section 12 is a planar spiral spring structure. Since the implant 1 is straightened to curled, the deformation amount is large, and the planar spiral spring structure can provide greater shrinkage force to the lung tissue. When fewer implants 1 are implanted, good lung volume reduction effect can also be achieved, greatly reducing the burden on the patient.

[0087] Third example

[0088] As shown in Figure 5 , the middle section 12 is a bending structure. The maximum width of the bending structure is consistent with the outer diameter D4 in the first example, and the cross-sectional area is substantially the same as in the first example. The bending structure has good clamping force (i.e. because it has certain edges, it can better clamp the lung tissue and prevent the two from slipping), and has good effect on shrinking lung tissue and is not easy to slip. Among them, the clamping force is the force to pull the implant 1 to move after being released into the bronchus E.

[0089] In some example embodiments, as shown in Figure 2 , Figure 7 , Figure 17As shown, the distal end 13 is flexible relative to the intermediate section 12, meaning the rigidity of the distal end 13 is less than that of the intermediate section 12. The distal end 13 can be made of a material with good elasticity and biocompatibility and is used to penetrate the initial end of the bronchus E. The surface of the distal end 13 needs to be smoothed to avoid damaging the inner wall of the bronchus E and improve the safety of the distal end 13 when it enters the bronchus E. In related technologies, lung volume reduction coils have relatively rigid ends that can easily damage the inner wall of the bronchus. In this application, the distal end 13 is relatively soft and smoothed when it enters the bronchus E, effectively protecting the inner wall of the bronchus E.

[0090] It should be noted that the materials described in this application are illustrative and do not constitute a limitation on this application. Any material that can be made into a flexible form and is not harmful to the human body is acceptable, subject to the actual situation.

[0091] In this embodiment, a radiopaque marker (not shown in the figure) is provided at the distal end 13. The radiopaque marker is formed by winding a filament into a spring-like structure. The radiopaque marker is made of a 0.01mm-0.3mm thick metal wire with strong X-ray radiopaque properties, such as tungsten or tantalum, and is wound into a spring shape as a radiopaque marker. Alternatively, the radiopaque marker can be formed at the distal end 13 by polymer heat shrink tubing or film coating, adhesive bonding, laser welding, soldering, etc., to facilitate intraoperative X-ray radiopaque imaging.

[0092] The length of the distal end 13 can be, for example, 3mm-6mm, preferably 4mm, which ensures that the bronchus E is compressed without damaging the inner wall of the bronchus E. The distal end 13 can be a single-layer structure or a composite structure, etc. The structural form and dimensions of the distal end 13 will be further illustrated below with different examples to better understand the technical solution in this application.

[0093] First Example

[0094] like Figures 7-11 As shown, the distal end 13 includes an inner core layer 131 and an outer core layer 132. The outer core layer 132 is cylindrical and is fitted over the inner core layer 131 to cover it. The rigidity of the outer core layer 132 of the distal end 13 is less than that of the inner core layer 131. The inner core layer 131 is made of, for example, a metallic material or a polymer material, preferably a metallic material, such as SUS316L, nickel-titanium alloy, cobalt-nodium alloy, silicone, etc. The outer core layer 132 is made of, for example, a metallic material or a polymer material, preferably composed of an elastic polymer material, such as soft PU, Pebax, nylon, etc.

[0095] The covering pattern between the outer core layer 132 and the inner core layer 131 can be adjusted according to the actual situation to meet different needs during surgery and adapt to different emphysema environments.

[0096] For example, as shown in Figure 8 , the inner core layer 131 is cylindrical, and the outer core layer 132 is hollow cylindrical, forming a structure in which the cross section of the distal end part 13 is consistent with the cross section of the middle section 12, which is suitable for the case where the sizes of the bronchus E in the use area are similar. For example, as shown in Figure 9 , the outer core layer 132 is hollow cylindrical, and the cross-sectional area of the inner core layer 131 gradually decreases from the proximal end part 11 to the distal end part 13, so that the inner core layer 131 is configured to be conical, which is suitable for the case where the sizes of the bronchus E in the use area are similar. Compared with the structure as shown in Figure 8 , since the volume of the outer core layer 132 is larger, the distal end part 13 can be made more flexible, and the risk of the distal end part 13 damaging the wall of the bronchus E can be further reduced. For example, as shown in Figure 10 , the cross-sectional area of the inner core layer 131 gradually decreases from the proximal end part 11 to the distal end part 13, and the shape of the outer core layer 132 is consistent with the shape of the inner core layer 131 and decreases, which is suitable for the case where the distal end size of the bronchus E in the use area is smaller than the proximal end size, so as to avoid excessive blockage of the bronchus E and affect its normal function. For example, as shown in Figure 11 , the cross-sectional area of the inner core layer 131 gradually decreases from the proximal end part 11 to the distal end part 13, and the cross-sectional area of the outer core layer 132 gradually increases, and the size of the distal end part 13 is slightly larger, so that it is easier to observe during surgery, and the contact area between the distal end part 13 and the wall of the bronchus E is large, the friction is larger, and it is more difficult to move, which effectively reduces the friction bleeding and the probability of occurrence of complications such as inflammation.

[0097] It should be noted that the shape and size of the inner cavity of the outer core layer 132 are consistent with the shape and size of the outer part of the inner core layer 131 to form a cladding structure.

[0098] It can be understood that in the above examples, the rigidity of the outer core layer 132 is smaller than the rigidity of the inner core layer 131, and the hardness of the inner core layer 131 and the outer core layer 132 can be varied and designed in combination with the cross-sectional area to ensure that the flexibility of the distal end part 13 is greater than the flexibility of the middle section 12, so as to avoid the distal end part 13 from damaging the bronchus E. The cross-sectional area of the distal end part 13 can be greater than, equal to, or less than the cross-sectional area of the middle section 12, as long as the flexibility is greater than the flexibility of the middle section 12, and a double-layer structure is adopted, and the outer core layer 132 can improve the corrosion resistance and flexibility of the distal end part 13, which is subject to the actual situation.

[0099] Second Example

[0100] The distal end 13 comprises an inner core layer 131 or an outer core layer 132, and has a single-layer structure. From the proximal end 11 to the distal end 13, the cross-sectional area of the distal end 13 gradually decreases. When the material of the distal end 13 is a relatively hard material, such as SUS316L, the head end of the distal end 13 has a curved surface structure, such as a complete spherical smooth body or a smooth body with a partial spherical shape, and the outer diameter is 30%-100% of the diameter of the middle section 12. If the outer diameter of the distal end 13 is too small, the bronchus E is easily injured, and if the outer diameter of the distal end 13 is too large, the distal end 13 is easily stuck in the catheter 212 (described in detail in the following embodiment) of the delivery mechanism 2, resulting in a failed operation. When the material of the distal end 13 is a relatively soft material, such as soft silica gel, the distal end 13 can not have a curved surface structure.

[0101] The distal end 13 is made of a material with good elasticity and biocompatibility, which improves the safety of the distal end 13 when it is inserted into the bronchus E. Compared with the structure in which the outer core layer 132 covers the inner core layer 131 in the first example, the distal end 13 in this example has a smaller overall profile, which in turn reduces the profile size of the catheter 212, facilitating miniaturization design.

[0102] Third Example

[0103] As shown in Figure 14 , Figure 15 , the distal end 13 comprises an inner core layer 131 and an outer core layer 132, and has a double-layer structure. The inner core layer 131 is made of a metal material and has a tapered shape, and the outer core layer 132 is wrapped around the inner core layer 131 in a spring shape, similar to a conventional guide wire structure, and has the characteristics of a soft guide wire head end. The length of the distal end 13 is 5mm-150mm, and the distal end 13 has good bending introduction performance. The implant 1 can have the function of the guide wire head end at the same time, and does not need to use a guide wire additionally, simplifying the operation and reducing the burden on the patient.

[0104] In some example embodiments, as shown in Figure 2 , Figure 12 , Figure 13 , Figure 17 , the structure in this embodiment is similar to that in the above-mentioned embodiments, and the difference is that the distal end 13 is provided with a smooth body 133, which has a curved surface structure and is blunt. When the smooth body 133 contacts the bronchus E, it is difficult to penetrate into the bronchus E wall, which can further reduce the trauma to the patient.

[0105] The smooth body 133 can be directly fixedly connected along the extension direction of the distal end 13 (see Figure 12 ), or can be indirectly connected at an angle to meet different surgical needs.

[0106] In this embodiment, asFigure 13 As shown, the distal end part 13 comprises a distal end straight segment 135 and a bending segment 134, the bending segment 134 is connected with the middle segment 12 through the distal end straight segment 135. Among them, the bending segment 134 and the distal end straight segment 135 have a preset included angle, for example, when the implant 1 is in a coil shape, the bending segment 134 bends to the side away from the implant 1, and the bending angle a can be 95°-175°, preferably 110°-175°.

[0107] When implanted by surgery, it can conform to the angle of the bronchus E, and ensure that the implant surgery is successfully performed. The bending segment 134 has a bending angle, for example, the line perpendicular to the tail end point of the helical body of the middle segment 12 is the tangent b, and the plane perpendicular to the tangent b and passing through the tail end point of the middle segment 12 is the normal plane a, and the distal end part 13 and the middle segment 12 are respectively on both sides of the normal plane a.

[0108] Alternatively, the bending segment 134 is connected with the distal end straight segment 135, and the axis parallel to the distal end straight segment 135 is the tangent b, and the distal end part 13 and the middle segment 12 are respectively on both sides of the normal plane a.

[0109] When the implant 1 is recovered, if the bending angle and the middle segment 12 are distributed on one side of the normal plane a, when recovered and straightened, the distal end part 13 needs to be reversely turned to the other side of the normal plane a, and this process is extremely easy to hit the inner wall of the bronchus E, causing the inner wall of the bronchus E to be scratched or the turning to fail. If the turning fails, the acute angle formed is easy to hang the catheter 212 when the implant 1 is recovered, causing the recovery to fail.

[0110] It should be noted that the smooth body 133 can be connected with the side of the bending segment 134 away from the distal end straight segment 135, so as to contact and support the bronchus E. The smooth body 133 provided on the distal end part 13 can also be in the form of a radiographic marker, so as to identify the implant position of the smooth body 133. The form of the radiographic marker has been described in detail in the foregoing examples, and will not be repeated here. Of course, it can be understood that the smooth body 133 can also not be provided on the bending segment 134 in some examples, and the bending segment 134 directly abuts against the bronchus E, and the specific situation is subject to the actual situation.

[0111] In some example embodiments, as shown in Figure 2 , Figure 17 As shown, the rigidity of the proximal end part 11 is smaller than the rigidity of the middle segment 12. Among them, the proximal end part 11 comprises a flexible segment 111 and a second connecting part 112 connected with the flexible segment 111.

[0112] The flexible section 111 is connected with the intermediate section 12, and the structure of the flexible section 111 can refer to the structure of the distal end section 13, such as a single-layer structure, a double-layer structure, and the like, which will not be repeated here. The rigidity of the flexible section 111 of the proximal end section 11 is greater than the rigidity of the distal end section 13. The rigidity of the flexible section 111 is less than the rigidity of the intermediate section 12, which can not only support the intermediate section 12 and the distal end section 13 during delivery, but also press the bronchus E, and the flexible section 111 is relatively soft and will not cause damage to the inner wall of the bronchus E. The length of the flexible section 111 can be 3mm-7mm, and preferably 5mm.

[0113] The second connecting section 112 is detachably connected with the first connecting section 22, and the structure of the second connecting section 112 is adapted to the structure of the first connecting section 22. The second connecting section 112 will be further illustrated by different examples, so as to better understand the technical solutions in the present application.

[0114] First example

[0115] As shown in Figure 2 , Figure 17 , the second connecting section 112 is in the shape of an olive, so that the first connecting section 22 clamps the second connecting section 112, or the second connecting section 112 is embedded in the first connecting section 22, to achieve detachable connection.

[0116] The surface of the second connecting section 112 is smooth, which can avoid damage to the inner wall of the bronchus E when the delivery mechanism 2 releases the implant 1. The cross-sectional area of the second connecting section 112 is preferably greater than the cross-sectional area of the flexible section 111, and the cross-sectional edge curve of the second connecting section 112 in any direction is a closed smooth curve, so as to avoid damage to the bronchus E and improve the safety during the operation.

[0117] Second example

[0118] As shown in Figure 16 , Figure 17 , the second connecting section 112 is in the shape of an olive, so that the first connecting section 22 clamps the second connecting section 112, or the second connecting section 112 is embedded in the first connecting section 22, to achieve detachable connection.

[0119] In order to avoid the outer diameter size of the flexible section 111 being too large to affect the operation effect, the end of the flexible section 111 away from the middle section 12 is provided with an adapter section 114 and a support section 113, and the support section 113 is fixedly connected with the flexible section 111 through the adapter section 114. The flexible section 111, the adapter section 114 and the support section 113 can be an integrated structure, which improves the reliability during connection. The adapter section 114 can shrink the end size of the flexible section 111, so as to avoid the outer diameter size being too large to affect the implantation or recovery effect. The support section 113 expands the outer diameter size, so as to increase the contact area with the second connecting part 112 and improve the reliability during connection of the support section 113 with the second connecting part 112.

[0120] For example, the outer diameter size of the second connecting part 112 is D1, the outer diameter size of the support section 113 is D2, the inner diameter size of the second connecting part 112 is D3, and the outer diameter size of the adapter section 114 is d3.

[0121] The end outer diameter size D2 of the support section 113 is smaller than the inner diameter size D3 of the second connecting part 112, so that the support section 113 can be embedded in the second connecting part 112. The support section 113 can be connected with the second connecting part 112 by pressing or welding, so as to improve the connection effect. The inner cavity of the second connecting part 112 can be compatible with the end of different support sections 113, so that the applicability is stronger.

[0122] In addition, the outer diameter size D1 of the second connecting part 112 can be equal to or smaller than the maximum outer diameter size d2 of other parts of the implant 1, such as the outer diameter size D1 of the second connecting part 112 being equal to or smaller than the outer diameter size d2 of the flexible section 111, so that the end size does not become a factor for increasing the outer diameter size of the catheter 212. Of course, it can be understood that d2 can not only be the flexible section 111, but also the middle section 12 (d1) of the implant 1, and the specific situation is subject to the actual situation.

[0123] The outer diameter size d3 of the adapter section 114 can be smaller than the outer diameter size D2 of the support section 113, and the outer diameter size D2 of the support section 113 is smaller than the maximum cross section d2 of the other middle sections 12 of the implant 1, so as to achieve this purpose, reduce the resistance during operation, shorten the operation time, and further reduce the harm to the patient.

[0124] Here, it should be noted that the connection between the proximal end part 11 and the first connecting part 22 is not limited to the above-mentioned manner, but can also be provided with a groove structure, and the first connecting part 22 is connected by the groove and the convex surface lock to achieve connection; or, magnetic connection, sleeve lock connection, etc., and the specific situation is subject to the actual situation. The second connecting part 112 can be connected with the delivery mechanism 2 after being released in place, and is used for disengaging connection, so as to achieve the implantation purpose of the implant 1 and perform interventional therapy.

[0125] The proximal end size of the lung volume reduction coil in the related art is large, and the outer diameter size of the matched catheter also needs to be increased accordingly, so that it is difficult to implant the lung volume reduction coil into the lung bypass or the end of some small-diameter trachea during the operation, and the range of the emphysema area squeezed and pulled by the lung volume reduction coil is limited, which affects the volume reduction effect.

[0126] The proximal end part 11 in the present example is obviously reduced in cross-sectional size compared with the proximal end cross-sectional size in the related art. The second connecting part 112 is, for example, a hollow cylindrical structure, and the end for connecting with the first connecting part 22 is processed into an internally threaded pipe, which is easier to process threads.

[0127] In the present embodiment, as shown in Figure 2 , Figure 6 The proximal end part 11 further includes a proximal end straight section 115, and the flexible section 111 is connected with the middle section 12 through the proximal end straight section 115.

[0128] When the implant 1 is retrieved, as shown in Figure 23 , which is a schematic view without the proximal end straight section 115, the proximal end part 11 of the implant 1 is easy to stick to the wall of the bronchus E, and it is difficult for the retrieval instrument to grasp, which is easy to fail in retrieval. As shown in Figure 24 , which is a schematic view with the proximal end straight section 115, the proximal end straight section 115 forms a raised state at the tail end of the bronchus E, so that the second connecting part 112 is not stuck to the inner wall of the bronchus E, which is beneficial to the grasping of the grasping instrument.

[0129] The length of the proximal end straight section 115 is, for example, 10-15 mm. If the length is too short, it is easy to cause no support for the end to be raised, and if the length is too long, it is easy to hit the inner wall of the bronchus E on the other side, causing damage thereto.

[0130] In some example embodiments, as shown in Figures 17-20 , the first connecting part 22 includes a plurality of clamping bodies 221, which are in the form of clamping jaws between the plurality of clamping bodies 221. The plurality of clamping bodies 221 are configured as clamping spaces 222 for clamping the second connecting part 112 of the proximal end part 11 of the implant 1.

[0131] One end of the clamping body 221 is fixedly connected with the pushing part 21, and the plurality of clamping bodies 221 can relatively move to open or close the clamping space 222.

[0132] It can be understood that the number of the clamping bodies 221 can be two, three, four or the like. When the number of the clamping bodies 221 is two, the two clamping bodies 221 are oppositely arranged to form the clamping space 222. When the number of the clamping bodies 221 is three or four, the clamping bodies 221 are sequentially and uniformly arranged along the circumference of the support steel cable 211 to form the clamping space 222. The number of the clamping bodies 221 is subject to actual conditions.

[0133] In some examples, as shown in Figures 17-20 The clamping body 221 includes an elastic segment 2211, a rigid segment 2212 and a semicircular arc segment 2213 which are sequentially connected. The elastic segment 2211 is connected to the pushing part 21.

[0134] The elastic segment 2211 has a plurality of elastic segments. When combined together and in a natural state, the elastic segments are in an open state. When an external pressure state occurs, the elastic segments are in a closed state. When the external pressure is removed, the elastic segments can return to the original state. The number of the elastic segments 2211 can be two, three or more, which are sequentially connected. The elastic segment 2211 is made of a metal material with good elasticity and biocompatibility, such as stainless steel, nickel-titanium alloy or the like.

[0135] The side of the rigid segment 2212 away from the elastic segment 2211 is provided with a certain curvature, which can constrain the second connecting part 112 of the implant 1. Alternatively, the rigid segment 2212 can be segmented and bent to form a certain angle, so as to constrain the implant 1. The specific connection mode is subject to actual conditions. The semicircular arc segment 2213 is arranged at the end of the rigid segment 2212. Under the constraint of the external side of the elastic segment 2211, the semicircular arc segment 2213 can be clamped on the second connecting part 112 of the proximal end 11, further improving the clamping effect.

[0136] It should be noted that the above is an example of the case where the second connecting part 112 is a smooth curved surface. The connection between the first connecting part 22 and the proximal end 11 of the implant 1 is not limited to the clamping mode. The first connecting part 22 can be a threaded groove, and the proximal end 11 can be a threaded column, so as to realize threaded connection. Alternatively, the connection mode between the first connecting part 22 and the second connecting part 112 of the proximal end 11 can also be to provide corresponding matching structures, for example, the first connecting part 22 and the second connecting part 112 are connected through a groove structure, magnetically connected, or connected through a sleeve lock, and the like. The specific connection mode is subject to actual conditions. As long as the implant 1 can be released in situ, the pushing action in the related art does not need to be performed, the accurate placement of the implant 1 is ensured, and the phenomenon of deviation does not occur. When the delivery mechanism 2 places the implant 1 in the bronchus E, the delivery mechanism 2 is arranged to controllably release or recover the implant 1, so as to realize accurate placement and recovery.

[0137] In the embodiment, as shown in Figures 17-20As shown, the pushing part 21 includes a supporting steel cable 211, which is fixedly connected to the elastic section 2211, ensuring a reliable connection between the supporting steel cable 211 and the elastic section 2211 and preventing loosening. The supporting steel cable 211 is, for example, made of multiple rigid metal wires wound together, and these rigid metal wires are made of a biocompatible metal material, such as stainless steel.

[0138] In this embodiment, as Figure 17 As shown, the pushing part 21 also includes a conduit 212, which is fitted onto the outside of the supporting steel cable 211. The conduit 212 and the supporting steel cable 211 have a first relative position and a second relative position.

[0139] When the catheter 212 is in the first relative position, it is located outside the implant 1, surrounding or covering the implant 1, so that the catheter 212 can constrain the clamping body 221 to close the clamping space 222 and clamp the second connecting part 112. At this time, the catheter 212 will also surround or cover part of the support cable 211, and will not completely leave the support cable 211 to prevent it from being unable to be withdrawn from the implant 1.

[0140] When the catheter 212 is in the second relative position, the catheter 212 is in a retracted state relative to the implant 1. The catheter 212 is located radially outside the supporting steel cable 211 and is withdrawn from the clamping body 221. The constraint force on the outside of the clamping body 221 is released, the clamping body 221 returns to its original state, and the clamping space 222 is opened, allowing the second connecting part 112 of the implant 1 to be released in a controllable manner. This ensures that the implant 1 will not be deviated and is directly placed at the position where lung volume reduction surgery is required, ensuring that the implant 1 corresponds to the lesion position and improving the accuracy of the surgery.

[0141] In this embodiment, as Figure 17 As shown, a high-contrast marker (not shown) is provided on the side of the support cable 211 near the proximal end 11 of the implant 1 to facilitate the determination of the positional relationship between the implant 1 and the support cable 211. The high-contrast marker may be, for example, a high-contrast metal strip, which may include gold, platinum, tantalum, iridium, tungsten, and / or similar metals.

[0142] In this embodiment, as Figure 17 , Figure 18 As shown, the pusher 21 also includes a marking line 213 on the side of the support cable 211 away from the proximal end 11, so as to monitor the insertion of the implant 1 into the catheter 212 or its release from the catheter 212.

[0143] When the tail end of the catheter 212 (i.e. the end away from the implant 1) is withdrawn to the mark line 213, the implant 1 is completely released from the catheter 212, and the release of the implant 1 can also be determined without using X-ray imaging.

[0144] In some examples, with reference to Figs. 1 and 2, the mark line 213 includes a first mark line 2131 and a second mark line 2132. Figure 21 and Figure 22 The first mark line 2131 and the second mark line 2132 are respectively used to indicate the relative position relationship between the head end of the distal end 13 (i.e. the end away from the delivery mechanism 2) and the catheter 212, i.e. the position of the head end of the distal end 13 exposed from the catheter 212.

[0145] When the tail end of the catheter 212 is located at the first mark line 2131, the head end of the distal end 13 is slightly exposed from the head end port of the catheter 212, and when the tail end of the catheter 212 is located at the second mark line 2132, the head end of the distal end 13 is mostly exposed from the head end port of the catheter 212, but not completely exposed from the head end port of the catheter 212, further determining the implantation of the implant 1 and improving the accuracy during the operation.

[0146] For the example in which the structure of the distal end 13 is that the inner core layer 131 is made of a metal material and the outer core layer 132 is wound in a spring shape on the inner core layer 131, the implant 1 acts as a guide wire and cooperates with the first mark line 2131 and the second mark line 2132 to better play the role of the guide wire.

[0147] It should be noted that the first mark line 2131 and the second mark line 2132 may be in the form of a pattern or may be an identifiable sensor to achieve intelligent recognition to automatically prompt the operator of the implantation of the implant 1, reduce manual checking, and improve the accuracy of identification.

[0148] The lung volume reduction implant device proposed in the present application may be made by, for example, winding a nickel-titanium alloy wire on a shaping mold and shaping into a target shape through heat treatment. The proximal end 11 is welded with the second connecting portion 112 by argon arc welding, and the proximal end 11 and the distal end 13 are polished to make the cross section smaller. In order to make the implant 1 have good corrosion resistance, the entire surface can be polished, and then a layer of high polymer material is melted on the surface of the distal end 13. This manufacturing method is only illustrative and does not limit the present application.

[0149] In the related art, the lung volume reduction coil procedure needs three independent operation processes of inserting a bronchoscope, establishing a channel, and implanting a product, and the operation time is relatively long. During the operation, the patient needs to be in a conscious state, and if the operation time is too long, the patient is prone to discomfort and the occurrence of adverse events such as acute exacerbation of COPD.

[0150] This application also proposes an implant 1 that cooperates with the delivery mechanism 2 of a lung volume reduction implantation device. The implant 1 includes a proximal end 11, a distal end 13, and an intermediate segment 12. The intermediate segment 12 is deformable between a coiled shape and a straightened shape. The proximal end 11 is detachably connected to the delivery mechanism 2, and the distal end 13 abuts against the inner wall of the bronchus E. The distal end 13 includes an inner core layer 131 and / or an outer core layer 132. The specific structure of the implant 1 has been described in detail in the above embodiments and will not be repeated here.

[0151] This application also proposes a delivery mechanism 2, which cooperates with the implant 1 of the lung volume reduction implantation device. The delivery mechanism 2 includes a pushing part 21 and a first connecting part 22 connected to the pushing part 21. The first connecting part 22 is detachably connected to the implant 1. The delivery mechanism 2 is configured to controllably release the implant 1, achieving in-situ release and improving accuracy. The specific structure of the delivery mechanism 2 has been described in detail in the above embodiments and will not be repeated here.

[0152] This application also proposes a lung volume reduction implantation system, such as Figures 1-25 As shown, it includes a monitoring module 3, a bronchoscope 4, and a lung volume reduction implantation device as described in any of the above embodiments. The bronchoscope 4 is connected to the monitoring module 3, and the lung volume reduction implantation device is installed on the bronchoscope 4.

[0153] The bronchoscope 4 is connected to the catheter 212 of the lung volume reduction implantation device, and the support cable 211 of the pusher 21 can pass through the bronchoscope 4.

[0154] The monitoring module 3 includes a first monitor 31, a remote imaging capture device 32, and a second monitor 33. The first monitor 31 and the remote imaging capture device 32 are electrically connected, and the second monitor 33 is electrically connected to the bronchoscope 4.

[0155] When the lung volume reduction implantation system is used clinically, a bronchoscope 4 is inserted through the mouth or nose. The bronchoscope 4 can detect the side away from the bronchoscope 4, and the detected images can be displayed on the second monitor 33, which can then guide the bronchoscope 4 to the bronchus E in the human lung.

[0156] After the lung volume reduction implantation device is assembled, it is inserted into the bronchoscope 4 through the working channel of the bronchoscope 4 and into the bronchus E. The marking line 213 of the lung volume reduction implantation device can indicate the distance along the implant 1 starting from the distal end 13.

[0157] The side of catheter 212 away from the proximal end 11 has multiple corresponding high-contrast markings, such as markings in the form of high-contrast metal strips, which may include gold, platinum, tantalum, iridium, tungsten and / or similar metals.

[0158] The implant 1 can be guided by a fluoroscopy system, an ultrasound imaging system, an MRI system, a computed tomography (CT) system or some other remote imaging capturing device 32. The remote imaging capturing device 32 can display the detected image on the first monitor 31, and the implant 1 can be identified by the remote imaging capturing device 32.

[0159] The catheter 212 is retracted, the implant 1 returns to the original shape, and the bronchus E is pulled into a coiled shape, thereby achieving the treatment effect of lung volume reduction. The implant 1 is released by the clamping body 221.

[0160] The lung volume reduction implant system proposed in the present application only needs two operation steps of inserting the bronchoscope 4 and delivering the product, and the operation is simple, which greatly reduces the operation time. The lung volume reduction implant 1 is contracted and concentrated to the center position of the spring-like structure, better clamps and fixes the bronchus E and achieves contraction, and avoids the phenomenon that coiling cannot be performed due to slipping.

[0161] In the case of achieving the same coiling effect, it is contracted and concentrated to the center position of the spring-like structure, which can be made with a smaller wire diameter, the cross-sectional area can be smaller, and is suitable for smaller catheters 212. In the present application, the coiling effect can be enhanced by increasing the number of turns, without increasing the cross-sectional area and the size of the catheter 212. The smaller catheter 212 outer diameter size can implant the implant 1 into the lung bypass or the end of some small diameter bronchus, and the emphysema area of the lung is large by the extrusion and pulling of the implant 1, and the volume reduction effect is good.

[0162] At the same time, the curved surface or smooth treatment can avoid puncturing the tissue, reduce the complications, and improve the safety during the operation.

[0163] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order in which they are described, unless specifically identified as an order dependent step. It is also to be understood that additional or alternative steps can be employed.

[0164] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first", "second", and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example implementations.

[0165] The foregoing is considered as illustrative only of the principles of the application. Numerous modifications and changes can readily occur to those skilled in the art, which modifications and changes are intended to be within the scope of the application. Accordingly, the scope of the application is to be interpreted only as is fairly required in view of the patent principles and novel features herein shown and described.

Claims

1. A lung volume reduction implantation device, characterized in that, It includes an implant and a delivery mechanism, the delivery mechanism being configured to controllably release the implant. The implant includes a proximal end, a distal end, and an intermediate segment. The intermediate segment is deformable between a coiled shape and a straightened shape. The distal end is used to insert into the bronchus. The rigidity of the proximal end and the distal end is less than that of the intermediate segment. The conveying mechanism includes a pushing part and a first connecting part connected to the pushing part, the first connecting part being detachably connected to the proximal end; The distal end includes a distal straight segment and a bent segment, the bent segment being connected to the intermediate segment via the distal straight segment; The bent segment and the distal straight segment have a preset angle. When the middle segment is curled, the bent segment bends away from the middle segment. The preset angle is between 95° and 175°. The distal end includes an inner core layer and an outer core layer. The rigidity of the outer core layer is less than that of the inner core layer. The outer core layer is a hollow cylinder. From the proximal end to the distal end, the cross-sectional area of ​​the inner core layer gradually decreases, making the inner core layer conical. The inner cavity shape and size of the outer core layer are consistent with the outer shape and size of the inner core layer to form an encapsulation structure. The distal end is provided with a smooth body, which is connected to the side of the bent segment away from the distal straight segment.

2. The lung volume reduction implantation device according to claim 1, characterized in that, The middle section is a spiral consisting of at least one turn.

3. The lung volume reduction implantation device according to claim 1, characterized in that, The middle section is a planar spiral spring structure.

4. The lung volume reduction implantation device according to claim 1, characterized in that, The middle section has a bent structure.

5. The lung volume reduction implantation device according to claim 1, characterized in that, The outer core layer is cylindrical to cover the inner core layer; or, the outer core layer is wound around the inner core layer in a spring-like manner.

6. The lung volume reduction implantation device according to claim 1, characterized in that, The distal end is provided with a developing mark, which is formed by winding a filament into a spring-like structure.

7. The lung volume reduction implantation device according to claim 1, characterized in that, The proximal end includes a flexible segment and a second connecting portion disposed on the flexible segment. The flexible segment is connected to the intermediate segment, and the second connecting portion is detachably connected to the first connecting portion. The second connecting portion is a rugby ball-shaped or hollow columnar structure.

8. The lung volume reduction implantation device according to claim 7, characterized in that, The flexible segment is provided with a transition segment and a support segment at one end away from the middle segment. The support segment is connected to the flexible segment through the transition segment. The support segment is fitted and connected to the second connecting part, and the second connecting part is threadedly connected to the first connecting part.

9. The lung volume reduction implantation device according to claim 8, characterized in that, The outer diameter of the transition section is smaller than that of the support section, the outer diameter of the support section is smaller than that of the inner diameter of the second connecting part, and the outer diameter of the support section is smaller than or equal to that of the intermediate section or the flexible section.

10. The lung volume reduction implantation device according to claim 7, characterized in that, The proximal end also includes a proximal straight segment, and the flexible segment is connected to the intermediate segment through the proximal straight segment.

11. The lung volume reduction implantation device according to claim 1, characterized in that, The first connecting portion includes a plurality of clamping bodies, and a clamping space is configured between the plurality of clamping bodies for clamping the implant; One end of the clamping body is fixedly connected to the pushing part, and the multiple clamping bodies are configured to move relative to each other to open or close the clamping space.

12. The lung volume reduction implantation device according to claim 11, characterized in that, The clamping body includes an elastic segment, a rigid segment, and a semi-circular arc segment connected in sequence; wherein, the elastic segment is connected to the pushing part.

13. The lung volume reduction implantation device according to claim 12, characterized in that, The pushing part includes a supporting steel cable and a conduit. The supporting steel cable is fixedly connected to the clamping body, and the conduit is fitted onto the outside of the supporting steel cable. The conduit and the supporting steel cable have a first relative position and a second relative position. When the catheter is in the first relative position, the catheter is located outside the implant, and the catheter is configured to constrain the clamping body to close the clamping space; When the catheter is in the second relative position, the catheter is located outside the supporting steel cable, and the catheter is configured to withdraw from the clamping body to open the clamping space and controllably release the implant.

14. The lung volume reduction implantation device according to claim 13, characterized in that, A high-contrast marker is provided on the side of the catheter away from the proximal end.

15. The lung volume reduction implantation device according to claim 13, characterized in that, A marking line is provided on the side of the support cable away from the near end.

16. A lung volume reduction implant, cooperating with a delivery mechanism of a lung volume reduction implantation device, characterized in that, The implant includes a proximal end, a distal end, and a middle segment; The distal end is used to penetrate the bronchus, and the rigidity of the proximal end and the distal end is less than that of the intermediate section; The middle section is deformable between a coiled shape and a straightened shape, the proximal end is detachably connected to the delivery mechanism, and the distal end abuts against the inner wall of the bronchus; The distal end includes an inner core layer and an outer core layer. The rigidity of the outer core layer is less than that of the inner core layer. The outer core layer is a hollow cylinder. From the proximal end to the distal end, the cross-sectional area of ​​the inner core layer gradually decreases, making the inner core layer conical. The shape and size of the inner cavity of the outer core layer are consistent with the external shape and size of the inner core layer to form an encapsulation structure. The distal end includes a distal straight segment and a bent segment, the bent segment being connected to the intermediate segment via the distal straight segment; The bent segment and the distal straight segment have a preset angle. When the middle segment is curled, the bent segment bends away from the middle segment. The preset angle is between 95° and 175°. The distal end is provided with a smooth body, which is connected to the side of the bent segment away from the distal straight segment.

17. A lung volume reduction implantation system, characterized in that, Includes a monitoring module, a bronchoscope, and a lung volume reduction implantation device as described in any one of claims 1-15; The bronchoscope is connected to the monitoring module, and the lung volume reduction implantation device is installed on the bronchoscope.

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