Auxiliary forming assembly and implantation instrument

Abstract

The auxiliary forming assembly comprises a first forming element and a first traction piece, the first forming element shuttles through a degradable implant, the first traction piece is connected to the first forming element, and the end, away from the first forming element, of the first traction piece penetrates out of the degradable implant. When the degradable implant is formed, the first traction piece drives the first forming element to move towards the near end, and then the first forming element drives the far end of the degradable implant to move towards the near end until the degradable implant is in a preset shape. According to the auxiliary forming element provided by the invention, the degradable implant can be formed into a more ideal shape during forming, and the implanting effect is better.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an auxiliary molding component and an implantable device. Background Art

[0002] Interventional therapy is a general term for a series of minimally invasive treatment techniques that use puncture needles, catheters and other instruments to introduce specific implantable devices into the lesion site of the human body through natural channels or tiny incisions under the guidance and monitoring of imaging equipment such as digital subtraction angiography, CT, ultrasound and magnetic resonance imaging. Because it can accurately and directly reach the lesion site without 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 many cardiovascular diseases.

[0003] An ideal implantable device is easy to operate, has a high implant success rate, and can be gradually degraded and disappear by the body after completing its "mission", leaving no 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, so that healthy tissue gradually replaces damaged tissue, which is conducive to re-intervention treatment.

[0004] However, since the rebound performance of degradable materials is significantly inferior to that of shape memory alloys, the biodegradable implants compressed in the catheter cannot completely restore their original shape after being pushed out, especially the degradable occluders, which are prone to incomplete occlusion, thus causing a series of complications.

[0005] Therefore, in order to compensate for the deficiencies in the resilience of biodegradable materials, the molding technology of biodegradable implants after release must be continuously improved. Utility Model Content

[0006] The purpose of the present application is to provide an auxiliary molding component and an implantation device, which can help a degradable implant to form a more ideal shape after release, thereby improving the implantation effect and reducing the risk of complications caused by insufficient rebound performance of the degradable implant.

[0007] The technical solutions provided by this application are as follows:

[0008] An auxiliary molding component, suitable for a degradable implant, comprising:

[0009] a first shaping element, shuttling through the degradable implant;

[0010] A first traction member connected to the first shaping element, wherein one end of the first traction member away from the first shaping element passes through the degradable implant;

[0011] When the degradable implant is formed, the first traction member drives the first forming element to move toward the proximal end, and the first forming element further drives the distal end of the degradable implant to move toward the proximal end until the degradable implant presents a preset shape.

[0012] In some embodiments, at least two second forming elements are spaced apart and distributed around the first forming element;

[0013] The second molding element shuttles through the degradable implant. When the degradable implant is molded, the second molding element drives the distal end of the degradable implant to move toward the proximal end until the degradable implant presents a preset shape.

[0014] In some embodiments, the auxiliary molding component further comprises:

[0015] A fixing member, connecting the first forming element and the first pulling member;

[0016] In an initial state, the fixing member is located inside the degradable implant; when the degradable implant is formed, the fixing member moves toward the proximal end driven by the first traction member, thereby driving the first molding element and / or the second molding element to move toward the proximal end.

[0017] In some embodiments, the second shaping element comprises a second shaping wire having two ends and a middle section between the two ends, wherein the middle section shuttles through the distal end of the degradable implant;

[0018] Wherein, one end of the second molding line is connected to the degradable implant, and the other end of the second molding line is fixed to or passes through the fixing piece; or, both ends of the second molding line are fixed to or pass through the fixing piece.

[0019] In some embodiments, the auxiliary molding component further comprises:

[0020] A synchronization member is fixed to the proximal end of the second forming element; a groove is formed at one end of the fixing member facing the first forming element, and the synchronization member is suitable for being clamped in the groove;

[0021] When the degradable implant is being formed, the fixing member and the synchronizing member respectively drive the corresponding first forming element and the second forming element to move toward the proximal end, and when the synchronizing member is locked in the slot, the first traction member drives the fixing member and the synchronizing member to move toward the proximal end synchronously until the degradable implant is completely formed; or, when the degradable implant is being formed, the fixing member and the synchronizing member respectively drive the corresponding first forming element and the second forming element to move toward the proximal end, and after the degradable implant is formed, the synchronizing member is locked in the slot.

[0022] In some embodiments, the auxiliary molding component further comprises:

[0023] A limiting member, fixed to the fixing member, and a guide slope is provided at one end of the limiting member away from the first forming element;

[0024] After the degradable implant is formed, the guide slope guides the fixing member to pass through the degradable implant, and one end of the limiting member facing the first forming element is pressed against the proximal end surface of the degradable implant.

[0025] In some embodiments, the limiting member includes an elastic abutment, the elastic abutment extends toward the distal end of the first forming element and a side away from the first forming element; and the side of the elastic abutment away from the first forming element forms the guide slope.

[0026] In some embodiments, the auxiliary molding component further comprises:

[0027] A molding plane, disposed at the distal end of the degradable implant;

[0028] The molding plane is provided with at least one through hole suitable for the second molding element to pass through, and the molding plane is used to provide support for the second molding element.

[0029] The present application also provides an implantable device, comprising:

[0030] A degradable implant and an auxiliary molding component that shuttles through the degradable implant, wherein the auxiliary molding component is the auxiliary molding component provided in any of the above embodiments.

[0031] In some embodiments, the implant device further comprises:

[0032] The developing element shuttles through the degradable implant.

[0033] In some embodiments, the first shaping element comprises a shaping rod, one end of the shaping rod is fixed to the distal end of the degradable implant, and the other end of the shaping rod is connected to the first traction member;

[0034] The forming rod is provided with a channel suitable for accommodating the developing element, and the developing element is connected with a third traction member, and the third traction member is suitable for driving the developing element to separate from the degradable implant from the channel.

[0035] The technical effects of this application are:

[0036] 1. In the present application, by providing a first molding element and a first traction member capable of pulling the first molding element, the distal end of the degradable implant is driven to move toward the proximal end when the degradable implant is released, which is beneficial to accelerate the rebound of the degradable implant and advance the surgical progress. At the same time, it can also help the degradable implant to form a more ideal shape and improve the implantation effect, thereby reducing the risk of complications caused by insufficient rebound performance of the degradable implant and accelerating the patient's recovery process.

[0037] 2. The present application also provides a second molding element that can cooperate with the first molding element to enable the various parts of the degradable implant to be molded more synchronously, so as to achieve a better molding effect and make the shape of the degradable implant closer to the ideal state; at the same time, the molding efficiency is also higher, which speeds up the surgical process.

[0038] 3. In the present application, by providing a synchronizing member and opening a slot on the fixing member for the synchronizing member to be engaged, the synchronizing member and the fixing member can move toward the proximal end respectively before engagement, and can move toward the proximal end synchronously after engagement, thereby eliminating the difference in movement efficiency between the first molding element and the second molding element. In this way, during the release process of the degradable implant, the surgeon can first pull the second traction member to preliminarily shape the degradable implant, and then pull the first traction member to complete the final shaping of the degradable implant, which is more conducive to the surgeon adjusting the shape of the degradable implant during the release process so that it can be better shaped into an ideal shape.

[0039] 4. In the present application, by setting a molding plane at the distal end of the degradable implant, the contact area between the second molding element and the degradable implant can be increased, making the connection between the second molding element and the degradable implant more stable. At the same time, it is also more conducive to the second molding element to drive the distal end of the degradable implant to move, so as to achieve a better molding effect.

[0040] 5. The present application sets a limiter and sets a guide slope at one end of the limiter away from the first forming element, so that when the degradable implant is formed, the limiter can be gradually inserted into the degradable implant under the traction of the first traction member and the guidance of the guide slope. In this way, when the degradable implant is completely formed, the surgeon releases the first traction member, and the end of the limiter facing the first forming element can be pressed against the proximal end face of the degradable implant, so that the degradable implant can be stably maintained in the ideal shape, the implantation effect is better, the risk of complications caused by insufficient resilience of the degradable implant is effectively reduced, and the patient's recovery process is accelerated. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The present application is further described in detail below with reference to the accompanying drawings and specific implementation methods:

[0042] Figure 1is a schematic diagram of the three-dimensional structure of an implant provided in one embodiment of the present application in the early stage of post-release molding;

[0043] Figure 2 is a schematic diagram of the three-dimensional structure of an implant after molding provided in one embodiment of the present application;

[0044] Figure 3 is a cross-sectional view of an implant provided in one embodiment of the present application after molding;

[0045] Figure 4 is a plan view of an implant provided in another embodiment of the present application after molding;

[0046] Figure 5 is a plan view of an implant provided in yet another embodiment of the present application after molding;

[0047] Figure 6 is a distal end view of an implant provided in one embodiment of the present application;

[0048] Figure 7 is a plan view of an auxiliary molding component provided in one embodiment of the present application;

[0049] Figure 8 is a plan view of an auxiliary molding component provided in another embodiment of the present application;

[0050] Fig. 9 This is a plan view of an implant after molding provided in yet another embodiment of the present application.

[0051] Description of Figure Numbers:

[0052] 100, auxiliary forming assembly; 110, first forming element; 111, first forming line; 112, forming rod; 120, stopper; 121, elastic abutment; 122, guide slope; 130, first traction member; 140, fixing member; 150, second forming element; 160, second traction member; 170, synchronizing member; 171, slotting; 180, forming plane; 181, perforation; 190, middle section;

[0053] 210, developing element; 220, third traction member;

[0054] 300. Degradable implant; 310. First supporting mesh portion; 320. Second supporting mesh portion; 330. Waist portion; 340. First integrated element; 350. Second integrated element; 360. Connecting element. DETAILED DESCRIPTION

[0055] 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.

[0056] 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.

[0057] 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.

[0058] "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 installed directly or through other components; "connection" can be directly connected or connected 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.

[0059] 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.

[0060] In the embodiments of the present application, "proximal end" refers to the end of the associated object that is close to the operator;

[0061] "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.

[0062] Interventional therapy can introduce specific implantable devices into the diseased parts of the human body through natural orifices or tiny incisions for minimally invasive treatment. It can reach the lesion directly and accurately without major trauma. It has the advantages of accuracy, safety, high efficiency, wide indications and few complications. It has now become an important treatment for many cardiovascular diseases.

[0063] For example, among several common cardiovascular diseases, the incidence of patent foramen ovale (PFO) in the population is about 20-34%; more and more clinical reports suggest that PFO may be related to diseases such as unexplained ischemic stroke and migraine with aura. In recent years, domestic and foreign guidelines / expert consensus have gradually reached a consensus: for patients with ischemic stroke who have not found other causes after a 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 made of nickel-titanium alloy wire as raw materials. Once implanted, they will remain in the heart permanently after endothelialization. If biodegradable materials are used for implants, the implants will only serve as a "scaffold" for tissue growth at the implant site. During the tissue repair process, the implants will gradually be naturally absorbed by the human body, and only the repaired human tissue will be retained.

[0064] Due to the limitations of their own material properties, degradable materials have weak resilience, and during the implantation process, most implants enter the human body through the inner cavity of the delivery catheter in a slender compressed configuration. This makes it difficult for the degradable implant to fully present the ideal shape (preset shape) required to repair the implantation position by relying on its own elasticity after release, which in turn affects the implantation effect. In particular, degradable occluders are prone to incomplete occlusion, which can cause a series of complications. Therefore, it is particularly important to continuously improve the release molding technology of biodegradable implants.

[0065] The following is a description with reference to the accompanying drawings:

[0066] See also Figures 1 to 3 , which is a structural schematic diagram of an implant device provided in an embodiment of the present application, the implant device includes a degradable implant 300 and an auxiliary molding component 100, and the auxiliary molding component 100 includes a first molding element 110 and a first traction member 130. Among them, the first molding element 110 shuttles through the degradable implant 300, and the first molding element 110 has a distal end and a proximal end, the proximal end of the first molding element 110 is connected to the first traction member 130, and the end of the first traction member 130 away from the first molding element 110 passes through the degradable implant 300.

[0067] When the operator releases the degradable implant 300, the degradable implant 300 is separated from the delivery catheter from the distal end to the proximal end in sequence, and the part of the degradable implant 300 that is not constrained by external force has a tendency to expand due to rebound. Because the degradable implant 300 itself is not elastic enough and cannot fully present the ideal shape (preset shape) required for repairing the implant position, the operator can drive the first molding element 110 to move toward the proximal end by pulling the first traction member 130 during the release process, and the first molding element 110 thereby drives the distal end of the degradable implant 300 to move toward the proximal end, providing external force support for the rebound of the degradable implant 300, thereby helping the degradable implant 300 to form a more ideal shape and improve the implantation effect. Moreover, the traction effect of the first molding element 110 on the degradable implant 300 can also accelerate the rebound of the degradable implant 300, which helps to quickly advance the surgical process and shorten the surgical time.

[0068] To ensure that the degradable implant 300 can maintain the desired ideal shape for a long time, the auxiliary molding assembly 100 may further include a stopper 120, which is located at the proximal end of the first molding element 110. After the degradable implant 300 presents the preset shape, the stopper 120 is used to limit the first molding element 110 from moving toward the distal end to fix the shape of the degradable implant 300, so that it can continue to function at the implantation position, which is conducive to enhancing the effectiveness of the implantation and avoiding complications.

[0069] In one example embodiment, see Figures 1 to 3 The auxiliary molding assembly 100 further includes a fixing member 140, which is used to connect the first molding element 110 and the first traction member 130. Specifically, the fixing member 140 is arranged at the proximal end of the first molding element 110, and a through hole is provided on the fixing member 140 for the first traction member 130 to pass through, and the first molding element 110 and the first traction member 130 are indirectly connected through the fixing member 140. The first traction member 130 has two ends, one end passes through the through hole and merges with the other end, and the operator can simultaneously pull the two ends of the first traction member 130 to drive the fixing member 140 and the first molding element 110 to move toward the proximal end through the first traction member 130. After the degradable implant 300 is implanted, the operator can pull one end of the first traction member 130 to drive the first traction member 130 to separate from the fixing member 140, and then withdraw from the human body, which is convenient for intraoperative operation.

[0070] During the delivery process of the degradable implant 300, the fixing member 140 is initially located in the degradable implant 300, and the first traction member 130 extends toward the proximal end until it passes through the delivery catheter for delivering the degradable implant 300 and passes out at the proximal end of the delivery catheter. At this time, the delivery device stretches the degradable implant 300 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. When the degradable implant 300 is delivered to the part of the human body to be implanted, the delivery device pushes the degradable implant 300 to leave the distal end of the delivery catheter, and the degradable implant 300 is successively freed from the restraint of the delivery catheter from the distal end to the proximal end, and has an expansion tendency. At this time, the first traction member 130 is pulled toward the proximal end, driving the fixing member 140 to move toward the proximal end inside the degradable implant 300, and then the first molding element 110 drives the distal structure of the degradable implant 300 to move toward the proximal end, helping the degradable implant 300 to become a more ideal shape. During this process, the fixing member 140 gradually moves to the proximal end of the degradable implant 300. At this time, the limiting member 120 at the proximal end of the first molding element 110 can limit the fixing member 140, so that the fixing member 140 remains at the proximal end of the degradable implant 300 to fix the shape of the occluder. In this way, when the operator withdraws the first traction member 130 and no longer applies tension to the first molding element 110, the degradable implant 300 can still maintain a relatively ideal shape, and the implantation effect is better.

[0071] In this embodiment, see Figures 1 to 3 The limiting member 120 can be set on the fixing member 140 as a separate structure. For example, a ring edge or a limiting boss is set on the side wall of the fixing member 140. The ring edge and the limiting boss are stuck on the proximal end surface of the degradable implant 300 after the fixing member 140 passes through the degradable implant 300 to limit the retrograde movement of the first molding element 110.

[0072] Of course, see Figure 4 , Figure 5 , Figure 7 and Figure 8 In actual production, the stopper 120 and the fixing member 140 can also be integrated into one structure, for example, integrated into an inverted cone structure with a small end at the proximal end and a large end at the distal end. When the fixing member 140 (stopper 120) gradually moves to the proximal end of the degradable implant 300, its proximal end structure and outer cone surface can guide the fixing member 140 (stopper 120) to pass through the proximal end of the degradable implant 300 more quickly. After passing through, its distal end structure can well press against the proximal end surface of the degradable implant 300, thereby limiting the first molding element 110 from moving backward.

[0073] See also Figures 1 to 5Based on the above-mentioned embodiments, the present application discloses an auxiliary molding component 100, which is applicable to the degradable implant 300, and is intended to help the degradable implant 300 to form and stably maintain a more ideal shape after release.

[0074] The current degradable implant 300 mainly includes a support mesh body woven from a plurality of braided wires. By setting a guide slope 122 at one end of the stopper 120 away from the first molding element 110, it is more conducive to the stopper 120 to pass out of the support mesh body. After passing out, the end of the stopper 120 facing the first molding element 110 can abut against the proximal end surface of the degradable implant 300 to prevent the first molding element 110 from going backwards, thereby stably maintaining the degradable implant 300 in the desired ideal shape, achieving a better implantation effect, effectively reducing the risk of complications caused by insufficient resilience of the degradable implant 300, and accelerating the patient's recovery process.

[0075] In a preferred embodiment, see Figure 2 and Figure 3 The stopper 120 is fixed to the fixing member 140 and includes an elastic abutment 121, which extends toward the distal end of the first molding element 110 and away from the first molding element 110 (or the fixing member 140). At this time, the elastic abutment 121 is gradually inclined outward from the proximal end to the distal end, and the side of the elastic abutment 121 away from the first molding element 110 (or the fixing member 140) forms the above-mentioned guide slope 122.

[0076] In this embodiment, the elastic abutment 121 is provided to increase the deformation capacity of the limiting member 120 , so that the limiting member 120 can pass through the self-supporting mesh more easily.

[0077] Specifically, see Figures 1 to 5 The degradable implant 300 further includes a first assembly element 340, a second assembly element 350 and a connecting element 360. The distal end of the supporting mesh is gathered in the first assembly element 340, and the proximal end of the supporting mesh is gathered in the second assembly element 350. The connecting element 360 is provided at the proximal end of the second assembly element 350 and is used to connect a delivery device, which is used for the operator to deliver the degradable implant 300 to the lesion site of the human body.

[0078] In actual production, the first assembly element 340 and the second assembly element 350 can be formed by melting and molding the ends of the woven support mesh, or by molding rods, tubes, etc. and then welding them to the support mesh, which is not limited here and is within the scope of protection of this application. Relatively speaking, the connecting element 360 and the second assembly element 350 can be directly integrally molded or separately molded, which is within the scope of protection of this application.

[0079] In this embodiment, the second assembly element 350 and the connecting element 360 are both provided with openings, through which the first traction member 130, the fixing member 140 and the limiting member 120 can pass. During the delivery process, the fixing member 140 and its upper limiting member 120 are both located in the supporting mesh, the connecting element 360 is connected to the distal end of the delivery device, and the first traction member 130 extends toward the proximal end until it passes through the delivery catheter and passes out at the proximal end of the delivery catheter. At this time, the delivery device stretches the degradable implant 300 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.

[0080] When the degradable implant 300 is delivered to the implantation site of the human body, the delivery device pushes the degradable implant 300 to leave the far end of the delivery catheter, and the degradable implant 300 is separated from the restraint of the delivery catheter from the far end to the near end, and the supporting mesh body has an expansion trend. At this time, the connection between the delivery device and the connecting element 360 is maintained, and the first traction member 130 is pulled toward the proximal end, driving the fixing member 140 to move toward the proximal end inside the second supporting mesh part 320, so that the first forming element 110 drives the first assembly element 340 to move toward the proximal end, helping the supporting mesh body to become a more ideal shape. At the same time, in this process, the elastic side 121 is squeezed by the inner wall of the opening on the second assembly element 350, and will be gathered in the direction of the first forming element 110 (or fixing member 140), until the limiter 120 completely passes through the degradable implant 300, and the elastic side 121 is no longer subject to the restraint of the second assembly element 350 and thus rebounds to a preset shape. After rebounding, the elastic abutment 121, whose end facing the distal end of the first molding element 110, can be pressed against the proximal end surface of the second assembly element 350, thereby preventing the fixing element from going backwards, so that the degradable implant 300 can be stably maintained in a more ideal shape after being released, and the implantation effect is better. Finally, the first traction member 130 is withdrawn from the human body, and the delivery device is separated from the connecting element 360, and the implantation is completed.

[0081] In this embodiment, the number of the elastic abutting edges 121 is at least two, and they are arranged at intervals on the proximal circumference of the first forming element 110 , so as to achieve a better limiting effect.

[0082] In a specific embodiment, see Figure 7 and Figure 8 The first molding element 110 includes a first molding line 111, and the two ends of the first molding line 111 are respectively fixed to the distal end of the degradable implant 300 (i.e., the first assembly element 340) and the fixing member 140. Of course, in actual production, in addition to this connection method, the first molding line 111 can also be connected to the degradable implant 300 and the fixing element in other connection methods.

[0083] For example, the first molding line 111 has two ends and a middle section 190 located between the two ends. Both ends of the first molding line 111 are fixed to the fixing member 140 to form the proximal end of the first molding element 110; the middle section 190 shuttles through the degradable implant 300, for example, crossing or winding around a part of the grid at the distal end of the supporting mesh body, so that the first molding line 111 drives the degradable implant 300 to be molded, wherein the middle section 190 shuttles through the distal end of the degradable implant 300 to form the distal end of the first molding element 110.

[0084] In addition, see Fig. 9 The first molding element 110 may also be in a tube or rod shape. For example, the first molding element 110 includes a molding rod 112, one end of which is fixed to the distal end of the degradable implant 300 (i.e., the first assembly element 340) to form the distal end of the first molding element 110, and the other end of which is fixed to the fixing member 140 to form the proximal end of the first molding element 110.

[0085] Considering that the first molding element 110 , the limiting element 120 and the fixing element 140 will eventually remain in the patient's body, in order to avoid leaving hidden dangers in the patient's body, the first molding element 110 , the limiting element 120 and the fixing element 140 are preferably made of degradable materials.

[0086] In a preferred embodiment, see Figure 4 and Figure 5 The auxiliary molding component 100 further includes at least two second molding elements 150, and the second molding elements 150 are spaced and distributed around the first molding element 110. In contrast, the second molding element 150 shuttles through the degradable implant 300 and has a distal end and a proximal end.

[0087] Among them, the proximal end of the second molding element 150 can be directly fixed on the fixing member 140, so that when the user pulls the first traction member 130, the first molding element 110 and the second molding element 150 can be directly driven to move synchronously, so that the various parts of the degradable implant 300 can be more synchronously molded. Especially when the supporting mesh body has a waist 330 with a larger radial dimension, or it itself is a shape with a larger axial dimension, such as an atrial septal defect occluder and a left atrial appendage occluder, the role of the second molding element 150 is more obvious, and the various parts of the supporting mesh body can be more synchronously molded into the disc shape required by the implantation position, and the molding efficiency is also higher, which greatly speeds up the operation process.

[0088] Alternatively, the second molding element 150 may also adopt a molding line structure, that is, the second molding element 150 includes a second molding line, and the second molding line has two ends and a middle section 190 located between the two ends. In this case, the middle section 190 of the second molding line passes through the degradable implant 300, and the two ends of the second molding line directly pass out of the degradable implant 300, or pass through the fixing member 140 first and then pass out of the degradable implant 300, so that the operator can grasp and pull the second molding element 150.

[0089] In addition, in actual production, the proximal end of the second molding element 150 may be directly or indirectly connected to the second traction member 160 in addition to being directly fixed to the fixing member 140 or passing through the degradable implant 300 for the operator to grasp, and the second traction member 160 may pass through the degradable implant 300 at one end away from the second molding element 150. In this way, the operator can pull the first traction member 130 and the second traction member 160 respectively to achieve the step-by-step molding of the degradable implant 300, which is more conducive to the operator adjusting the shape of the degradable implant 300 during the release process so that it can be better molded into an ideal shape. In this embodiment, the second traction member 160 may pass through the proximal end of the degradable implant 300 directly, or may pass through the fixing member 140 first and then pass through the proximal end of the degradable implant 300, which is not limited here and is within the protection scope of the present application.

[0090] In one example embodiment, see Figure 7 and Figure 8 The auxiliary molding assembly 100 may further include a synchronizing member 170 , which is disposed at the proximal end of the second molding element 150 . A groove 171 is formed at one end of the fixing member 140 facing the first molding element 110 , and the synchronizing member 170 is suitable for being clamped in the groove 171 .

[0091] In this embodiment, by providing a synchronizer 170 and providing a slot 171 on the fixing member 140 for the synchronizer 170 to be clamped, the synchronizer 170 and the fixing member 140 can move toward the proximal end respectively before being clamped, and can move toward the proximal end synchronously after being clamped, thereby eliminating the difference in movement efficiency between the first molding element 110 and the second molding element 150. In this way, when releasing the degradable implant 300, the operator can first pull the second traction member 160, and drive the synchronizer 170 and the second molding element 150 to move toward the proximal end through the second traction member 160, so that the degradable implant 300 is initially formed. After the synchronizer 170 is clamped in the slot 171, the first traction member 130 is pulled to complete the final molding of the degradable implant 300. This molding method is more conducive to the operator to adjust the shape of the degradable implant 300 during the release process, so that it can be better molded into an ideal shape.

[0092] Of course, in actual use, the operator may first pull the first traction member 130 and the second traction member 160 respectively, thereby driving the first molding element 110 and the second molding element 150 to move toward the proximal end, and then clamp the synchronization member 170 in the slot 171 after the degradable implant 300 is formed, so as to complete the entire molding process. Alternatively, the first traction member 130 and the second traction member 160 may be first pulled respectively, and before the degradable implant 300 is completely formed, the synchronization member 170 is clamped in the slot 171, and by pulling the first traction member 130, the first molding element 110 and the second molding element 150 are driven to move synchronously until the degradable implant 300 is completely formed.

[0093] Specifically, a through hole is provided in the slot 171, suitable for the second traction member 160 to pass through, and an opening is provided on the synchronizer 170 for the second traction member 160 to pass through. The second traction member 160 and the second forming element 150 are indirectly connected through the synchronizer 170, and one end of the second traction member 160 passes through the opening and merges with the other end of the second traction member 160.

[0094] The shape and external dimensions of the synchronization element should match the shape and outline of the slot 171, or be slightly larger than the shape and outline of the slot 171, so that there is a certain friction between the two. When the operator pulls the first traction member 130, the synchronization member 170 can move with the fixing member 140, that is, the second molding element 150 can move synchronously with the first molding element 110, and the molding effect is better.

[0095] In this embodiment, the synchronizing member 170 and the fixing member 140 are made of the same material and can both be elastic or slightly elastic. For example, an internal porous structure is adopted so that the limiting member 120 can pass through a narrow space without changing its own preset structure, thereby ensuring that the limiting member 120 still has a good limiting effect after passing through.

[0096] Specifically, see Figure 5 , Figure 7 and Figure 8 In the above-mentioned embodiments, the second forming element 150 can adopt a forming wire structure, that is, the second forming element 150 includes a second forming wire. Among them, both ends of the second forming wire can be fixed to the fixing member 140 or the synchronizing member 170 or directly connected to the second traction member 160 to form the proximal end of the second forming element 150; at the same time, the middle section 190 of the second forming wire shuttles through the degradable implant 300, specifically, it crosses or wraps around the part of the grid at the distal end of the supporting mesh body, and the middle section 190 shuttles through the distal end of the degradable implant 300 to form the distal end of the second forming element 150. Such a configuration can make the force transmission efficiency of the second forming element 150 higher, thereby making the structure of the degradable implant 300 after molding more stable and the implantation effect better.

[0097] Of course, see Figure 4 In actual production, the second molding line can also be fixed to the fixing member 140 at only one end, or fixed to the synchronizing member 170 at only one end, or directly connected to the second traction member 160 at only one end, thereby forming the proximal end of the second molding element 150, and the other end is directly fixed to the proximal end of the degradable implant 300.

[0098] On this basis, the second molding line can also be formed by extending part of the braided wire of the supporting mesh body, and one end of the extension is fixed to the fixing member 140 or fixed to the synchronizing member 170 or directly connected to the second traction member 160 to form the proximal end of the second molding element 150. No further details are given here, as they are all within the protection scope of this application.

[0099] Specifically, see Figure 3 and Figure 4 Taking the degradable implant 300 as a degradable occluder as an example, the degradable occluder can be used for congenital heart disease, left atrial appendage occlusion, etc., and the supporting mesh body thereon usually includes a first supporting mesh portion 310, a second supporting mesh portion 320, and a waist portion 330 located between the first supporting mesh portion 310 and the second supporting mesh portion 320. The first supporting mesh portion 310 and the second supporting mesh portion 320 are both woven from a plurality of braided wires, and one end of the first supporting mesh portion 310 away from the second supporting mesh portion 320 is gathered in the first collective element 340 to form the distal end of the degradable implant 300, and one end of the second supporting mesh portion 320 away from the first supporting mesh portion 310 is gathered in the second collective element 350 to form the proximal end of the degradable implant 300.

[0100] When one end of the second molding line is fixed to the degradable implant 300, one end of the second molding line can be fixed to the second supporting mesh part 320, and the structure is more concise. In contrast, when the second molding line is formed by extending part of the braided wire of the supporting mesh body, the second molding line can be formed by extending part of the braided wire on the second supporting mesh part 320, and the second molding line first passes through the first supporting mesh part 310 and then extends toward the proximal end.

[0101] In the above embodiments, the second molding element 150 is preferably made of a degradable material.

[0102] Among them, if both ends of the second molding line are directly connected to the second traction members 160, and both second traction members 160 can pass through the fixing member 140. Then, when the operator needs to pull the second molding element 150 to assist in molding the degradable implant 300, pulling the two second traction members 160 at the same time can drive the second molding element 150 connected thereto to move toward the proximal end. After the implantation is completed, the operator only needs to pull one of the second traction members 160 to achieve the withdrawal of the second traction line and the second molding element 150, which is easy to operate and has a simple structure. At this time, in addition to being made of degradable materials, the second molding line can also be made of non-biodegradable materials.

[0103] In a preferred embodiment, see Figure 6 The auxiliary molding component 100 may further include a molding plane 180, which is disposed at the distal end of the degradable implant 300 and has at least one through hole 181, suitable for the second molding element 150 to pass through. In this way, the molding plane 180 can provide support for the second molding element 150, so that the contact surface between the second molding element 150 and the supporting mesh is larger, and the connection is more stable. At the same time, it is also more conducive to the second molding element 150 to drive the distal end of the degradable implant 300 to move stably, so as to achieve a better molding effect.

[0104] Specifically, the width of the molding plane 180 is approximately 2-6 times the width of the grid frame on the supporting mesh, and the molding plane 180 can be formed by locally shaping the grid on the supporting mesh, or by welding the plane structure to the grid structure. No further restrictions are made here, and all are within the scope of protection of this application.

[0105] See also Figures 1 to 5 Based on the auxiliary molding component 100 provided in all the above embodiments, the present application further provides an implant device, which includes a degradable implant 300 and an auxiliary molding component 100 that shuttles through the degradable implant 300. The auxiliary molding component 100 is the auxiliary molding component 100 provided in any of the above embodiments, which helps the degradable implant 300 to form and stably maintain a more ideal shape after release, and the implantation effect is better, reducing the risk of complications caused by insufficient resilience of the degradable implant 300.

[0106] In a preferred embodiment, see Fig. 9 The implant device may also include a developing element 210, which shuttles through the degradable implant 300 and can follow the degradable implant 300 into the human body to help the degradable implant 300 to develop under medical images such as X-rays and TEE, so that the surgeon can accurately judge the position, status, etc. of the degradable implant 300 during the operation to ensure the implantation effect.

[0107] Considering that the developing element 210 is usually made of metal material, in order to leave only the degradable implant in the human body after the implantation is completed, the third traction member 220 connected to the developing element 210 is provided in this embodiment. After the implantation is completed, the developing element 210 can be driven to separate from the degradable implant 300 by pulling the third traction member 220.

[0108] Furthermore, the first molding element 110 includes a molding rod 112, one end of which is fixed to the distal end of the degradable implant 300 to form the distal end of the first molding element 110, and the other end is fixed to the fixing member 140 to form the proximal end of the first molding element 110. At this time, a channel may be provided in the molding rod 112 to form a tubular structure suitable for accommodating the above-mentioned imaging element 210. In this way, after the implantation is completed, the surgeon can pull the third traction member 220 to drive the imaging element 210 to separate from the degradable implant 300 from the channel, and the structure is more concise and convenient for production.

[0109] In the above embodiments, the description of each embodiment has its own emphasis. 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.

[0110] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. An auxiliary molding component suitable for a degradable implant, characterized in that: include: a first shaping element, shuttling through the degradable implant; A first traction member connected to the first shaping element, wherein one end of the first traction member away from the first shaping element passes through the degradable implant; When the degradable implant is formed, the first traction member drives the first forming element to move toward the proximal end, and the first forming element further drives the distal end of the degradable implant to move toward the proximal end until the degradable implant presents a preset shape.

2. The auxiliary molding assembly according to claim 1, characterized in that: Also includes: At least two second forming elements are spaced apart and distributed around the first forming element; The second molding element shuttles through the degradable implant. When the degradable implant is molded, the second molding element drives the distal end of the degradable implant to move toward the proximal end until the degradable implant presents a preset shape.

3. The auxiliary molding assembly according to claim 1 or 2, characterized in that: Also includes: A fixing member, connecting the first forming element and the first pulling member; In an initial state, the fixing element is located inside the degradable implant; When the degradable implant is formed, the fixing member moves toward the proximal end under the drive of the first traction member, thereby driving the first forming element and / or the second forming element to move toward the proximal end.

4. The auxiliary molding assembly according to claim 3, characterized in that: The second shaping element comprises a second shaping line, the second shaping line has two ends and a middle section between the two ends, and the middle section shuttles through the distal end of the degradable implant; Wherein, one end of the second molding line is connected to the degradable implant, and the other end of the second molding line is fixed to or passes through the fixing piece; or, both ends of the second molding line are fixed to or pass through the fixing piece.

5. The auxiliary molding assembly according to claim 3, characterized in that: Also includes: A synchronization member is fixed to the proximal end of the second forming element; a groove is formed at one end of the fixing member facing the first forming element, and the synchronization member is suitable for being clamped in the groove; When the degradable implant is being formed, the fixing member and the synchronizing member respectively drive the corresponding first forming element and the second forming element to move toward the proximal end, and when the synchronizing member is locked in the slot, the first traction member drives the fixing member and the synchronizing member to move toward the proximal end synchronously until the degradable implant is completely formed; or, when the degradable implant is being formed, the fixing member and the synchronizing member respectively drive the corresponding first forming element and the second forming element to move toward the proximal end, and after the degradable implant is formed, the synchronizing member is locked in the slot.

6. The auxiliary molding assembly according to claim 3, characterized in that: Also includes: A limiting member, fixed to the fixing member, and a guide slope is provided at one end of the limiting member away from the first forming element; After the degradable implant is formed, the guide slope guides the fixing member to pass through the degradable implant, and one end of the limiting member facing the first forming element is pressed against the proximal end surface of the degradable implant.

7. The auxiliary molding assembly according to claim 6, characterized in that: The limiting member includes an elastic abutment, the elastic abutment extends toward the distal end of the first forming element and a side away from the first forming element; and the side of the elastic abutment away from the first forming element forms the guide slope.

8. The auxiliary molding assembly according to claim 2, characterized in that: Also includes: A molding plane, disposed at the distal end of the degradable implant; The molding plane is provided with at least one through hole suitable for the second molding element to pass through, and the molding plane is used to provide support for the second molding element.

9. An implant device, characterized in that: include: A degradable implant and an auxiliary molding component that shuttles through the degradable implant, wherein the auxiliary molding component is the auxiliary molding component according to any one of claims 1-8.

10. The implant device according to claim 9, characterized in that Also includes: The developing element shuttles through the degradable implant.

11. The implant device according to claim 10, characterized in that The first shaping element comprises a shaping rod, one end of which is fixed to the distal end of the degradable implant, and the other end of which is connected to the first traction member; The forming rod is provided with a channel suitable for accommodating the developing element, and the developing element is connected with a third traction member, and the third traction member is suitable for driving the developing element to separate from the degradable implant from the channel.

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