Developing assembly and implantation instrument

Abstract

A developing assembly and an implant instrument, the developing assembly including a developing element and an extension, the developing element shuttling through a degradable implant, and a distal end of the developing element being connected to a distal end of the degradable implant. One end of the extension part is connected to the near end of the developing element, penetrates out of the degradable implant and is suitable for driving the far end of the developing element to be separated from the far end of the degradable implant, so that the developing element is driven to be separated from the degradable implant. In the application, by arranging the developing assembly, the degradable implant can be observed through medical images such as X-rays and TEE, so that an operator can accurately judge the position, the state and the like of the degradable implant, and the implantation effect is ensured. And after implantation is completed, the developing element can be taken away from the human body only by pulling the extension piece to enable the developing element to break through connection with the far end of the degradable implant, and only the degradable implant is reserved in the human body, so that potential hidden dangers after an operation are effectively reduced, and rapid repair of a patient is facilitated.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a developing component and an implanting device. Background Art

[0002] Interventional therapy is a general term for a series of techniques that, under the guidance and monitoring of imaging devices such as digital subtraction angiography machines, CTs, ultrasounds, and magnetic resonances, use puncture needles, catheters, and other instruments to introduce specific implanting devices into the human body's diseased parts through natural body orifices or tiny incisions for minimally invasive treatment. Because it can accurately reach the lesion directly, and at the same time has no major trauma, it has the advantages of accuracy, safety, high efficiency, wide indications, and few complications, and has now become an important treatment method for various cardiovascular diseases.

[0003] An ideal implanting device is easy to operate, has a high implantation success rate, and can be gradually degraded and disappear by the body after completing its "mission" without leaving any potential hidden dangers in the body. Therefore, the application of biodegradable materials is another breakthrough in the field of cardiac intervention. Compared with traditional implants, biodegradable implants retain the structural advantages of implants and can be degraded regularly and naturally absorbed by the human body, enabling healthy tissues to gradually replace damaged tissues, which is beneficial for repeated interventional treatment.

[0004] However, since biodegradable implants are mostly made by braiding and shaping biodegradable polymer filaments, they cannot be developed under X-rays, magnetic resonances, or CTs, and can only be guided by ultrasound imaging means during clinical applications. Cardiac interventional therapy must be carried out under the guidance of medical images such as X-rays and TEE (Trans Esophageal Echocardiography), and minimally invasive diagnosis and treatment of diseases are performed. During the operation, the progress of the operation needs to be judged by observing the interventional and implanting devices through medical images, which is the basis for the smooth progress of the operation. Therefore, continuous improvement of the developing technology of biodegradable implants is required. Summary of the Utility Model

[0005] The purpose of this application is to provide a developing component and an implanting device, enabling the operator to accurately judge the position, state, etc. of the biodegradable implant through the developing element to control the surgical process and ensure the implantation effect; and after the implantation is completed, the developing element can be separated from the human body, leaving only the biodegradable implant in the human body to reduce potential hidden dangers after the operation.

[0006] The technical solution provided by this application is as follows:

[0007] A developing component, applicable to a biodegradable implant, includes:

[0008] A developing element shuttles through the degradable implant. The developing element has a distal end and a proximal end, and the distal end of the developing element is connected to the distal end of the degradable implant.

[0009] An extension member, one end of the extension member is connected to the proximal end of the developing element and passes through the degradable implant, and is adapted to drive the distal end of the developing element away from the distal end of the degradable implant, thereby driving the developing element to withdraw from the degradable implant.

[0010] In some embodiments, the developing element includes a developing section, the material of the developing section includes metal, and the developing section has an elongated strip structure or a spring structure.

[0011] In some embodiments, the developing element further includes a connecting section, and the number of the developing sections is two. The two developing sections are connected by the connecting section.

[0012] In some embodiments, the developing assembly further includes:

[0013] A developing channel, one end of the developing channel is fixed to the distal end of the degradable implant, and the other end of the developing channel is fixed to the proximal end of the degradable implant;

[0014] The developing element is disposed in the developing channel, and the extension member is adapted to drive the developing element to withdraw from the developing channel, thereby withdrawing from the degradable implant.

[0015] In some embodiments, the radial dimension of the developing channel is adapted to the radial dimension of the developing element.

[0016] In some embodiments, the material of the developing channel includes a degradable material.

[0017] This application also provides an implanting instrument, including:

[0018] A degradable implant and a developing assembly shuttling through the degradable implant, and the developing assembly is the developing assembly provided in any of the above embodiments.

[0019] In some embodiments, the degradable implant includes a support mesh, a first collecting element, and a second collecting element;

[0020] The support mesh has a distal end and a proximal end. The distal end of the support mesh is bundled in the first collecting element, and the proximal end of the support mesh is bundled in the second collecting element; and,

[0021] The developing element shuttles through the support mesh, and the distal end of the developing element is connected to the first collecting element, and the extension passes through the second collecting element and extends outside the support mesh.

[0022] In some embodiments, the support mesh includes a first support mesh portion and a second support mesh portion, and a waist is formed between the first support mesh portion and the second support mesh portion;

[0023] The developing element includes a developing section and a connecting section. The number of the developing sections is two, namely a first developing section and a second developing section, and the first developing section and the second developing section are connected by the connecting section; and, the first developing section shuttles through the first support mesh portion, the second developing section shuttles through the second support mesh portion, and the connecting section shuttles through the waist.

[0024] In some embodiments, the first developing section extends along the outer surface contour of the first support mesh portion, and, the second developing section extends along the outer surface contour of the second support mesh portion;

[0025] Or

[0026] The developing element extends along the axial direction of the support mesh.

[0027] In some embodiments, the developing assembly further includes a developing channel;

[0028] The support mesh is woven by a plurality of woven wires, and the developing channel shuttles between the woven wires and is formed in the support mesh; the developing element is disposed in the developing channel, so as to shuttle through the support mesh.

[0029] In some embodiments, the implanting device further includes:

[0030] A shaping assembly, the shaping assembly includes a shaping element and a traction member;

[0031] The shaping element has a distal end and a proximal end. The distal end of the shaping element is connected to the distal end of the degradable implant, and the traction member is connected to the proximal end of the shaping element and passes out from the proximal end of the degradable implant;

[0032] When releasing the degradable implant, the traction member is adapted to drive the shaping element to move towards the proximal end, and the shaping element further drives the distal end of the degradable implant to move towards the proximal end until the degradable implant presents a preset shape.

[0033] The technical effect of the present application is as follows:

[0034] 1. This application provides a developing element that can shuttle through the degradable implant, which is beneficial for the operator to timely observe and obtain the position and state of the degradable implant during the operation, and is convenient for the operator to judge the progress of the operation, thereby controlling the progress of the operation and ensuring the implantation effect. At the same time, the proximal end of the developing element is also connected to an extension piece. After the implantation is completed, the operator applies a certain pulling force to the extension piece, which can drive the developing element to break through the connection with the distal end of the degradable implant and withdraw the developing element from the human body. In this way, only the degradable implant is retained in the patient's body after the operation. The degradable implant will gradually degrade until it completely disappears from the body. There are fewer potential risks after the operation, which is more conducive to the patient's rapid postoperative repair and has strong practicality.

[0035] 2. In the present application, the developing element may include two developing sections and a connecting section between the two developing sections, and the connecting section does not have a developing function. The developing assembly can be used in a degradable occluder. In this case, the two developing sections are used for developing the first supporting mesh and the second supporting mesh, respectively, so that the surgeon can observe the exact position of the first supporting mesh and the second supporting mesh. At the same time, the surgeon can also judge the relative position of the first supporting mesh and the second supporting mesh and the implanted tissue through the non-developing connecting section, which is more conducive to surgical operation.

[0036] 3. In the present application, the developing assembly may also include a developing channel, and the developing element is disposed in the developing channel. When the developing element is withdrawn from the degradable implant, the interaction between the developing element and the degradable implant only occurs in the developing channel, and the influence on the implantation morphology of the degradable implant is also greatly reduced, thereby ensuring the implantation effect. Moreover, the present application may also make the radial dimension of the developing channel adapted to the radial dimension of the developing element, so that the friction between the developing element and the inner wall of the developing channel is controllable, thereby further increasing the withdrawal efficiency of the developing element and reducing the influence on the degradable implant.

[0037] 4. In the present application, the developing channel is made of degradable material and can be woven together with multiple braided wires so that the developing channel can be integrated into the supporting mesh and adapt to the grid direction of the supporting mesh, so that the distribution path of the developing element can be integrated with the mesh structure of the supporting mesh, the structure is more stable, and the developing effect is further optimized. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The present application is further described in detail below with reference to the accompanying drawings and specific implementation methods:

[0039] Figure 1 is a schematic structural diagram of an implantable device provided in one embodiment of the present application;

[0040] Figure 2 is a schematic structural diagram of an implant device provided in another embodiment of the present application;

[0041] Figure 3It is a schematic structural diagram of an implant device provided in another embodiment of the present application;

[0042] Figure 4 It is a partial structural schematic diagram of a developing element provided in an embodiment of the present application;

[0043] Figure 5 It is a schematic structural diagram of an implant device provided in yet another embodiment of the present application;

[0044] Figure 6 It is a schematic structural diagram of a support mesh body in a tubular shape in the manufacturing method of an implant device provided in an embodiment of the present application;

[0045] Figure 7 It is Figure 6 A schematic structural diagram after both ends of the shown support mesh body are closed;

[0046] Figure 8 It is Figure 7 A schematic structural diagram after the shown support mesh body is shaped;

[0047] Figure 9 It is Figure 8 A schematic structural diagram after the shown support mesh body forms a first assembly element and a second assembly element and then forms a degradable implant;

[0048] Figure 10 It is Figure 9 A schematic structural diagram after the shown degradable implant is arranged with a developing element.

[0049] Explanation of reference numerals in the drawings:

[0050] 100. Developing assembly; 110. Developing element; 111. Developing section; 112. Connecting section; 120. Extension piece; 130. Developing channel;

[0051] 200. Degradable implant; 210. First support mesh part; 220. Second support mesh part; 230. Waist part; 240. First assembly element; 250. Second assembly element; 260. Connecting element;

[0052] 300. Forming assembly; 310. Forming element; 320. Traction piece; 330. Fixing element. Detailed implementation manners

[0053] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. The accompanying drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other accompanying drawings and other implementation methods can be obtained based on these drawings without creative work. Adjustments and improvements made without departing from the concept of the present application are all within the scope of protection of the present application.

[0054] In order to simplify the drawings, the drawings in the embodiments of the present application only schematically show the parts related to the present application, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some drawings, only parts with the same structure or function are schematically shown, and there may be more or fewer parts with the same structure or function in reality.

[0055] In this application, unless otherwise clearly specified and limited, ordinal numbers, such as "first", "second", etc., are only used to distinguish and describe related objects, and cannot be understood as indicating or implying the relative importance or order between related objects; in addition, they do not represent the number of related objects. "And / or" is used to describe the relationship between related objects, which includes any relationship between related objects. For example, "a and / or b" includes: "a alone", "b alone", or "a and b". The terms "installation" and "connection" should be understood in a broad sense. For example, "installation" can be direct installation or installation through other components; "connection" can be direct connection or connection through other components. The term "relatively arranged" includes parallel relative or relative at a certain angle. The angle is not limited and is determined according to the number of relatively arranged objects.

[0056] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0057] In the embodiments of the present application, "proximal end" refers to the end of the associated object that is close to the operator;

[0058] "Distal end" refers to the end of the associated object that is away from the operator. "Proximal end" and "distal end" refer to the position or direction of the associated object (e.g., a component of a medical device) relative to the operator (e.g., a doctor) who uses the device (e.g., a medical device) on which the associated object is located. For example, "proximal end" refers to the end that is closer to the doctor during the doctor's normal operation of the medical device, while "distal end" refers to the end that is away from the doctor during the doctor's normal operation of the medical device, that is, the end that enters the patient's body first.

[0059] Interventional therapy can introduce specific implant devices into the lesion site of the human body through natural body orifices or small incisions for minimally invasive treatment. Because it can accurately reach the lesion directly, and at the same time has no major trauma, it has the advantages of accuracy, safety, high efficiency, wide indications, and few complications. It has now become an important treatment method for various cardiovascular diseases.

[0060] For example, among several common cardiovascular diseases, the population incidence of patent foramen ovale (PFO) is about 20-34%; more and more clinical reports suggest that PFO may be related to diseases such as cryptogenic ischemic stroke and migrainous aura. In recent years, domestic and foreign guidelines / expert consensuses have gradually reached an agreement: for ischemic stroke patients who have not found other causes after comprehensive diagnostic evaluation, transcatheter PFO closure can reduce the risk of stroke recurrence. At present, the implants used for transcatheter closure are mainly traditional occluders prepared by weaving and shaping nickel-titanium alloy wires. Once implanted, they remain permanently in the heart after endothelialization. If biodegradable materials are applied to the implants, the implants only serve as the "scaffold" for the growth of the tissue at the implantation site. During the tissue repair process, the implants are gradually absorbed by the human body naturally, and only the repaired human tissue remains.

[0061] However, most biodegradable occluders are fabricated by weaving and shaping biodegradable polymer filaments and cannot be visualized under X-ray, magnetic resonance imaging (MRI), or computed tomography (CT). Cardiac interventional therapy requires minimally invasive diagnosis and treatment of diseases under the guidance of medical images such as X-ray and transesophageal echocardiography (TEE). During the operation, it is necessary to observe the biodegradable occluder through medical images to judge the progress of the operation, which is the basis for the smooth progress of the operation. Therefore, it is particularly important to continuously improve the imaging technology of biodegradable implants.

[0062] The following is a description with reference to the accompanying drawings:

[0063] See Figures 1 to 3 , which is a schematic structural diagram of an implant device provided by an embodiment of the present application. The implant device includes a biodegradable implant 200 and an imaging component 100. The imaging component 100 is disposed on the biodegradable implant 200 and can enter the human body following the biodegradable implant 200 to help the biodegradable implant 200 be visualized under medical images such as X-ray and TEE, so that the operator can accurately judge the position, state, etc. of the biodegradable implant 200 during the operation and ensure the implantation effect.

[0064] The developing component 100 is usually made of metal materials, such as alloys like tungsten gold, nickel-titanium, nickel-chromium, stainless steel, etc., to enhance the developing effect. After implantation, if the developing component 100 remains in the human body together with the degradable implant 200, the degradable implant 200 can be naturally absorbed by the human body over time, while the metal-made developing component 100 cannot be removed after endothelialization is completed, affecting the complete degradation effect of the implant.

[0065] In this regard, referring to Figures 1 to 4 , an embodiment of the present application provides a developing component 100, including a developing element 110 and an extension piece 120. Among them, the developing element 110 shuttles through the degradable implant 200, enabling the degradable implant 200 to be developed under medical images such as X-rays and TEE, facilitating the observation by the surgeon. The developing element 110 has a distal end and a proximal end. The distal end of the developing element 110 is connected to the distal end of the degradable implant 200, and one end of the extension piece 120 is connected to the proximal end of the developing element 110 and passes through the degradable implant 200, being suitable for driving the distal end of the developing element 110 to separate from the distal end of the degradable implant 200, and further driving the developing element 110 to withdraw from the degradable implant 200.

[0066] In this way, after the implantation of the degradable implant 200 is completed, the surgeon only needs to apply a certain pulling force value to the extension piece 120 to drive the developing element 110 to break its connection with the distal end of the degradable implant 200, withdraw the developing element 110 from the human body, and only leave the degradable implant 200 in the human body. And the degradable implant 200 can be naturally absorbed by the human body over time, effectively eliminating the implant in the patient's body after the operation, and only leaving the repaired human tissue, with strong practicability.

[0067] In this embodiment, the extension piece 120 is only used for the surgeon to pull the developing element 110 to separate from the degradable implant 200 and does not need to have a developing function. Therefore, the extension piece 120 can be made of polymer materials.

[0068] Specifically, referring to Figures 1 to 3 , the developing element 110 includes a developing section 111, and the developing section 111 is the part of the developing element 110 for developing, which is usually made of metal materials. For example, when the developing element 110 is a metal piece in the shape of a slender strip or a spring structure, the entire developing element 110 is the developing section 111, which is used to help the degradable implant 200 develop.

[0069] Of course, in actual production, the developing element 110 can also be made of polymer materials, with a metal coating applied thereon. The metal coating can form a developing section 111 on the developing element 110 to help the degradable implant 200 develop. Details are not described one by one here, and all are within the protection scope of the present application.

[0070] In this embodiment, the developing segments 111 on the developing element 110 may be continuously distributed in one piece or discontinuously distributed in multiple segments. Refer to Figure 2 and Figure 3 . If the developing segments 111 are discontinuously distributed in multiple segments, the developing element 110 further includes a connecting segment 112, which may be made of a polymer material and does not have a developing function. At this time, the number of the developing segments 111 is at least two, and the two developing segments 111 are connected by the connecting segment 112.

[0071] Specifically, refer to Figure 2 and Figure 3 . Taking the degradable implant 200 as a degradable occluder as an example, the degradable occluder can be used for congenital heart disease, left atrial appendage occlusion, etc., and usually includes a first support mesh part 210, a second support mesh part 220, and a waist part 230 located between the first support mesh part 210 and the second support mesh part 220. In this embodiment, the developing element 110 may specifically include two developing segments 111. For the convenience of description, the two developing segments 111 are respectively a first developing segment 111 and a second developing segment 111, and the first developing segment 111 and the second developing segment 111 are connected by a connecting segment 112. Among them, the first developing segment 111 shuttles through the first support mesh part 210, the second developing segment 111 shuttles through the second support mesh part 220, and the connecting segment 112 shuttles through the waist part 230. In this way, the operator can not only observe the accurate positions of the first support mesh part 210 and the second support mesh part 220 through the first developing segment 111 and the second developing segment 111, but also judge the relative positions of the first support mesh part 210 and the second support mesh part 220 and the implanted tissue through the non-developing connecting segment 112, which is more conducive to the operator's surgical operation and ensures the implantation effect.

[0072] In actual production, both the first support mesh part 210 and the second support mesh part 220 are woven by a plurality of braided wires. In this case, if the developing member directly shuttles through the first support mesh part 210 and the second support mesh, it will inevitably contact the plurality of braided wires. When the developing element 110 is withdrawn from the degradable occluder, the friction force between it and other braided wires may affect the implanted shape of the degradable occluder and may also affect the withdrawal efficiency of the developing element.

[0073] In response to this, refer to Figure 2, in a preferred embodiment, the developing component 100 may further include a developing channel 130 made of a degradable material. One end of the developing channel 130 is fixed to the distal end of the degradable implant 200, and the other end is fixed to the proximal end of the degradable implant 200. At this time, the developing element 110 can be threaded through the developing channel 130 and thus shuttles through the degradable implant 200. Conversely, when the operator pulls the developing element 110 through the extension member 120, the developing element 110 can withdraw from the developing channel 130 and thus from the degradable implant 200. During the withdrawal process, the interaction between the developing element 110 and the degradable implant 200 only occurs within the developing channel 130, greatly reducing the impact on the implanted shape of the degradable implant 200 and its own withdrawal efficiency, thus ensuring the implantation effect.

[0074] In addition, by providing the developing channel 130, the potential impact of the developing element 110 on human tissue can also be minimized during implantation, avoiding friction between the metal part of the developing element 110 and human tissue. The structure is more reasonable and practical.

[0075] Furthermore, the radial dimension of the developing channel 130 is adapted to the radial dimension of the developing element 110, which can make the friction force between the developing element 110 and the inner wall of the developing channel 130 controllable, further increasing the withdrawal efficiency of the developing element 110 and reducing the impact on the degradable implant 200.

[0076] In actual production, the developing channel 130 can be woven together with a number of braided wires to form the degradable implant 200. That is, when forming the degradable implant 200, a network-shaped support mesh is formed by braiding one developing channel 130 and multiple degradable braided wires. After the support mesh is shaped, the required degradable implant 200 is formed. At this time, the developing channel 130 can be regarded as a part of the support mesh. The developing channel 130 can adapt to the grid orientation of the support mesh, and is interwoven with other braided wires or support rods of the support mesh in a warp and weft manner, so that the distribution path of the developing element 110 can be integrated with the mesh structure of the support mesh (degradable implant 200), the structure is more stable, and the developing effect is further optimized.

[0077] See Figures 1 to 3, based on the developing component 100 provided in all the above embodiments, the present application further provides an implanting device, which includes a degradable implant 200 and a developing component 100 that shuttles through the degradable implant 200. Among them, the developing component 100 includes a developing element 110 and an extension member 120. The developing element 110 is initially connected to the degradable implant 200, which can help the surgeon observe the position, state, etc. of the degradable implant 200. After the degradable implant 200 is implanted, the developing element 110 can be driven by the extension member 120 to separate from the degradable implant 200 and evacuate from the human body, thereby reducing potential hidden dangers after surgery.

[0078] Specifically, the degradable implant 200 includes a support mesh, a first collecting element 240, and a second collecting element 250. The support mesh has a distal end and a proximal end. The distal end of the support mesh is bundled within the first collecting element 240, and the proximal end of the support mesh is bundled within the second collecting element 250. At this time, the distal end of the developing element 110 is connected to the first collecting element 240, and the developing element 110 starts from the first collecting element 240, shuttles through the support mesh until it extends to the second collecting element 250; the extension member is connected to the proximal end of the developing element 110, passes through the second collecting element 250 and extends outside the support mesh. Among them, the developing element 110 may only pass through some meshes on the support mesh, and there is no limitation here.

[0079] Specifically, the support mesh is woven by a plurality of braided wires, and the first collecting element 240 at the distal end of the support mesh and the second collecting element 250 at the proximal end may be formed by melting and shaping the ends of the woven support mesh, or may be formed by shaping rods, tubes, etc. and then welded to the support mesh. There is no limitation here, and they are all within the protection scope of the present application.

[0080] Specifically, the degradable implant 200 is further provided with a connecting element 260 at the proximal end of the second collecting element 250 for connecting a conveying device, and the conveying device is used for the surgeon to convey the degradable implant 200 to the diseased part of the human body. In actual production, the connecting element 260 and the second collecting element 250 may be directly integrally formed or may be formed separately.

[0081] Specifically, the distal end of the developing element 110 and the first collecting element 240 can be connected by welding or adhesion; and independent extension channels can be provided on the second collecting element 250 and the connecting element 260 for the extension member 120 to pass through. That is, the developing element 110 starts from the first collecting element 240 and extends continuously towards the proximal end until it extends to the second collecting element 250; the extension wire passes through the second collecting element 250 and the connecting element 260 in sequence and extends continuously towards the proximal end until it extends out of the proximal end of the conveying catheter.

[0082] In actual production, refer to Figure 1 andFigure 2 The developing element 110 can extend along the outer surface contour of the support mesh. If the support mesh includes a first support mesh portion 210, a second support mesh portion 220, and a waist portion 230 located between the first support mesh portion 210 and the second support mesh portion 220; and the developing element 110 includes a first developing segment 111 that shuttles through the first support mesh portion 210, a second developing segment 111 that shuttles through the second support mesh portion 220, and a connecting segment 112 that connects the first developing segment 111 and the second developing segment 111; then, the first developing segment 111 can extend along the outer surface contour of the first support mesh portion 210, and the second developing segment 111 can extend along the outer surface contour of the second support mesh portion 220.

[0083] Of course, in actual production, referring to Figure 3 The developing element 110 can also extend along the axial direction of the support mesh. If the support mesh includes a first support mesh portion 210, a second support mesh portion 220, and a waist portion 230 located between the first support mesh portion 210 and the second support mesh portion 220; and the developing element 110 includes a first developing segment 111 that shuttles through the first support mesh portion 210, a second developing segment 111 that shuttles through the second support mesh portion 220, and a connecting segment 112 that connects the first developing segment 111 and the second developing segment 111; then, the first developing segment 111 should be located between the distal end and the proximal end within the first support mesh portion 210, and the length of the first developing segment 111 is approximately the preset axial thickness when the first support mesh portion 210 is formed into an ideal disc shape. Correspondingly, the second developing segment 111 is located between the distal end and the proximal end within the second support mesh portion 220, and the length of the second developing segment 111 is approximately the preset axial thickness when the second support mesh portion 220 is formed into an ideal disc shape.

[0084] In a specific embodiment, referring to Figure 2 The developing assembly 100 further includes a developing channel 130 that starts from the first collecting element 240 and extends along the outer surface contour of the support mesh until the second collecting element 250 and the connecting element 260. The distal end of the developing channel 130 can be connected to the first collecting element 240, such as by welding, fusing, etc. Especially in an embodiment where the first collecting element 240 is formed by melting the end of the support mesh, the distal end of the developing channel 130 can be a part of the first collecting element 240.

[0085] In this embodiment, the developing element 110 can be arranged along the extending direction of the developing channel 130. The extension piece 120 sequentially passes through the second collecting element 250 and the connecting element 260 and extends continuously towards the proximal end until it extends out of the proximal end of the delivery catheter.

[0086] Referring to Figures 1 to 3 and Figure 5, in all of the above embodiments, since the biodegradable implant 200 is limited by its own material and has poor resilience, a forming assembly 300 needs to be provided to assist the biodegradable implant 200 to be formed into an ideal shape (predetermined shape). Specifically, the implant device further includes a forming assembly 300, and the forming assembly 300 further includes a forming element 310 and a traction member 320. Among them, the forming element 310 has a distal end and a proximal end, and the distal end of the forming element 310 is connected to the distal end of the biodegradable implant 200 (i.e., the first assembly element 240), and the traction member 320 is connected to the proximal end of the forming element 310 and passes out from the proximal end of the biodegradable implant 200 (i.e., the second assembly element 250, the connecting element 260).

[0087] When the operator releases the biodegradable implant 200, the traction member 320 is adapted to drive the forming element 310 to move proximally, and the forming element 310 further drives the distal end of the biodegradable implant 200 to move proximally until the biodegradable implant 200 presents a predetermined shape. Among them, the forming element 310 can be a wire, a rod, a tube, etc., which is not limited here, as long as it can assist the biodegradable implant 200 to be formed, and all are within the protection scope of this application.

[0088] Specifically, the forming assembly 300 further includes a fixing element 330, the fixing element 330 is arranged at the proximal end of the forming element 310, and the traction member 320 is connected to the forming element 310 through the fixing element 330.

[0089] During the transportation process of the biodegradable implant 200, the fixing element 330 is located inside the support mesh, the connecting element 260 is connected to the distal end of the delivery device, and the traction member 320 extends proximally all the time until it passes through the delivery catheter and exits at the proximal end of the delivery catheter. At this time, the delivery device stretches the biodegradable implant 200 from the proximal end to the distal end, and enters the human body through the inner cavity of the delivery catheter in an elongated compressed configuration.

[0090] When the biodegradable implant 200 is transported to the implantation site in the human body, the delivery device pushes the biodegradable implant 200 away from the distal end of the delivery catheter. The biodegradable implant 200 sequentially breaks free from the restraint of the delivery catheter from the distal end to the proximal end, and the support mesh all has a tendency to expand, but its own elasticity is not enough to make it completely present the ideal shape (predetermined shape) required for the repair implantation position.

[0091] At this time, keep the connection between the delivery device and the connecting element 260, pull the traction member 320 proximally, drive the fixing element 330 to move proximally inside the support mesh, and then make the forming element 310 drive the first assembly element 240 to move proximally to help the support mesh become a more ideal shape.

[0092] The fixing element 330 includes a limiting portion. The fixing element 330 sequentially passes through the second set element 250 and the connecting element 260 until it moves to the proximal end of the connecting element 260. At this time, the distal end of the limiting portion on the fixing element 330 can abut against the proximal end of the connecting element 260 to restrict the reverse movement of the forming element 310 and fix the shape of the occluder. Finally, the traction member 320 is withdrawn from the human body, and the delivery device is separated from the connecting element 260, and the implantation can be completed.

[0093] In one exemplary embodiment, referring to Figure 3 , the developing channel 130 can also be arranged in the forming element 310 and extend substantially along the axial direction of the degradable implant 200. At this time, the developing element 110 is arranged along the extending direction of the developing channel 130, and the extension member 120 extends out of the proximal end of the fixing element 330 and continues to extend proximally until it extends out of the proximal end of the delivery catheter. This structural arrangement can make the structure of the implanting instrument more concise and facilitate production.

[0094] Referring to Figures 6 to 10 , for the implanting instrument provided in all the above embodiments, the present application further provides a manufacturing method of the implanting instrument, including the steps:

[0095] S1. Process the degradable micro-tube.

[0096] S2. Referring to Figure 6 , a net-shaped support body is woven from a degradable micro-tube and multiple degradable braided wires, wherein the braided wires are long and tubular nets.

[0097] S3. Select a support body of a certain length and close one or both ends of the support body. Specifically, referring to Figure 7 , the end points of the support body are heat-melted and shaped to form a gathering point, or a degradable rod is welded to the end points of the support body to form a gathering point. In the above process, a fusion blocker such as a metal short rod with a suitable size can be placed in the degradable micro-tube at one end of the support body, so that after welding, the fusion blocker can be removed to retain the internal channel of the degradable micro-tube at one end of the support body. The above fusion blocker only needs to have a melting point higher than that of the degradable wire and rod, and there is no limitation here.

[0098] S4. Referring to Figure 8 , the support body is shaped according to the application scenario to obtain a preset shape. For example, a disk-shaped first support portion 210 and a second support portion 220 are formed; if necessary, a waist portion 230 connecting the first support portion 210 and the second support portion 220 can be shaped together. Referring to Figure 9, when shaping, it is also necessary to shape the endpoints, especially the proximal endpoints (forming the second assembly element 250), which can make the degradable implant 200 more suitable for actual use. During this process, the connection element 260 is arranged at the proximal end of the support mesh, and the internal channels of the second assembly element 250 and the connection element 260 are arranged. Among them, the connection element 260 can be directly processed by subtractive manufacturing from the assembly point of the support mesh, or processed from a rod and then welded or fused to the assembly point, and the internal channel for the fixing element 330 on the connection element 260 can also be processed by subtractive manufacturing.

[0099] S5. Refer to Figure 10 , arrange the imaging element 110 and the shaping assembly 300 on the support mesh. The imaging element 110 is threaded through the degradable micro-tube, and the distal end of the imaging element 110 is connected to the distal end of the support mesh. The distal end of the imaging element 110 can be detached from the distal end of the support mesh under a preset external force. The shaping assembly 300 includes a shaping element 310 and a fixing element 330. The shaping element 310 is composed of a wire, a rod, or a tube, and is welded or fused to the fixing element 330. The distal end of the shaping element 310 is welded or fused to the assembly point at the distal end of the support mesh. The fixing element 330 can be processed by subtractive manufacturing from a rod into a designed shape. In an embodiment where the shaping element 310 and the imaging channel 130 are combined into one, the fixing element 330 also needs to be processed with an extension line channel.

[0100] Specifically, the processing of the degradable micro-tube may further include the steps of: first winding the degradable material around a nitinol wire; then putting the wound degradable material and the nitinol wire into a thermoplastic tube for heating; after heating and forming, taking out the wound degradable material and the nitinol wire from the thermoplastic tube, and then extracting the middle nitinol wire, thus completing the forming of the degradable micro-tube. Of course, in actual production, methods such as tube extrusion can also be used for micro-tube processing, which will not be elaborated here one by one, and all are within the protection scope of this application.

[0101] In the above embodiments, the descriptions of each embodiment have their own focuses. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0102] It should be noted that the above embodiments can be freely combined according to needs. The above is only the preferred embodiment of this application. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the principle of this application, several improvements and refinements can be made, and these improvements and refinements should also be regarded as within the protection scope of this application.

Claims

1. A developing assembly, suitable for a degradable implant, characterized in that: include: A developing element, which shuttles through the degradable implant, wherein the developing element has a distal end and a proximal end, and the distal end of the developing element is connected to the distal end of the degradable implant; An extension piece, one end of which is connected to the proximal end of the developing element and passes through the degradable implant, and is suitable for driving the distal end of the developing element to detach from the distal end of the degradable implant, thereby driving the developing element to withdraw from the degradable implant.

2. The developing assembly according to claim 1, characterized in that: The developing element comprises a developing section, the material of the developing section comprises metal, and the developing section is in a slender strip structure or a spring structure.

3. The developing assembly according to claim 2, characterized in that: The developing element further includes a connecting section, and the number of the developing sections is two, and the two developing sections are connected by the connecting section.

4. The developing assembly according to any one of claims 1 to 3, characterized in that: Also includes: A development channel, one end of which is fixed to the distal end of the degradable implant, and the other end of which is fixed to the proximal end of the degradable implant; The developing element is disposed in the developing channel, and the extending member is suitable for driving the developing element to withdraw from the developing channel, thereby withdrawing from the degradable implant.

5. The developing assembly according to claim 4, characterized in that: The radial dimension of the developing channel is adapted to the radial dimension of the developing element.

6. The developing assembly according to claim 4, characterized in that: The material of the developing channel includes a degradable material.

7. An implant device, characterized in that: include: A degradable implant and a developing component that shuttles through the degradable implant, wherein the developing component is the developing component according to any one of claims 1-6.

8. The implant device according to claim 7, characterized in that The degradable implant comprises a supporting mesh, a first assembly element and a second assembly element; The support mesh has a distal end and a proximal end, the distal end of the support mesh is gathered in the first collective element, and the proximal end of the support mesh is gathered in the second collective element; and, The developing element shuttles through the supporting mesh body, and the distal end of the developing element is connected to the first collecting element, and the extending piece passes through the second collecting element and extends to the outside of the supporting mesh body.

9. The implant device according to claim 8, characterized in that The supporting net body comprises a first supporting net portion and a second supporting net portion, and a waist portion is formed between the first supporting net portion and the second supporting net portion; The developing element includes a developing section and a connecting section, the number of the developing sections is two, namely a first developing section and a second developing section, the first developing section and the second developing section are connected by the connecting section; and the first developing section shuttles through the first supporting net portion, the second developing section shuttles through the second supporting net portion, and the connecting section shuttles through the waist.

10. The implant device according to claim 9, characterized in that The first developing section extends along the outer surface contour of the first supporting mesh portion, and the second developing section extends along the outer surface contour of the second supporting mesh portion; or The developing element extends along the axial direction of the supporting mesh body.

11. The implant device according to any one of claims 8 to 10, characterized in that: The developing assembly further includes a developing channel; The support mesh body is woven from a plurality of woven wires, and the development channel shuttles between the woven wires and is formed in the support mesh body; The developing element is arranged in the developing channel so as to shuttle through the supporting net body.

12. The implant device according to any one of claims 7 to 10, characterized in that: Also includes: A molding assembly, the molding assembly comprising a molding element and a traction member; The shaping element has a distal end and a proximal end, the distal end of the shaping element is connected to the distal end of the degradable implant, and the traction member is connected to the proximal end of the shaping element and passes through the proximal end of the degradable implant; When releasing the degradable implant, the traction member is adapted to drive the shaping element to move toward the proximal end, and the shaping element further drives the distal end of the degradable implant to move toward the proximal end until the degradable implant presents a preset shape.

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