Multifunctional foreign matter capturing device and operation method thereof

Abstract

The invention provides a multifunctional foreign matter capturing device and an operation method thereof. The foreign matter capturing device comprises a capturing assembly and a claw-shaped structure, the claw-shaped structure is arranged at the far end of the capturing device and composed of capturing arms, the same position of the far end of each capturing arm is provided with a barb structure, barb tips of the barb structures face the central axis of the capturing assembly, and roots of the barb structures are connected with the capturing arms. The outward protruding structure is bent from the far end to the near end; the furling assembly is arranged to be of a sleeve structure, and the furling assembly starts to extrude the capturing arm from the near end through the inner wall so that the capturing assembly can be gradually furled into the furling assembly; the far end of the conveying assembly is connected with the grabbing assembly and the folding assembly, and the near end of the conveying assembly is connected with an operation assembly used for operating the grabbing assembly and the folding assembly. Some embodiments of the present disclosure aim to achieve a more friendly interventional operation and a higher error-tolerant rate of foreign matter capture operation by providing a capture assembly having a special structure.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to a multifunctional foreign body capturing device and an operating method thereof. Background Art

[0002] Valvular heart disease is a common heart disease, with rheumatic fever causing valvular damage being the most common. The human body has four valves: the mitral, tricuspid, aortic, and pulmonary valves. Valvular heart disease refers to single-valve or multi-valve disease caused by conditions such as rheumatic fever, myxomatous degeneration, degenerative changes, congenital malformations, ischemic necrosis, infection, or trauma. This affects normal blood flow, leading to abnormal heart function and ultimately heart failure.

[0003] Currently, the most common treatment for mitral valve disease is transcatheter edge-to-edge mitral valve repair (TMR). This procedure is being performed worldwide, with a large patient base and rapid product adoption. Consequently, a growing number of related interventional products are available. Currently, the most common treatment options for tricuspid valve disease are transcatheter edge-to-edge tricuspid valve repair (TMR) and transcatheter tricuspid annuloplasty (TAN). These procedures can be categorized by their operating principle: edge-to-edge clips and annuloplasty clips.

[0004] However, the different designs of existing products and the large number of patients present a significant risk of adverse events during surgery. For example, SLDA (Single Leaflet Device Attachment) often occurs during TEER surgery. This refers to the detachment of the single leaflet from the valve leaflet after clamping during TEER surgery, resulting in loss of connection. It is the most common structural device failure after TEER and is more common in complex lesions. If an adverse event occurs during surgery, the implant must be immediately removed for annular replacement or other procedures. Currently, the more traditional method is open-chest surgery, which is still a major trauma to the patient.

[0005] Therefore, the existing technology needs to be improved and enhanced.

[0006] It should be noted that the above introduction to the technical background is merely intended to provide a clear and complete description of the technical solutions of this application and facilitate understanding by those skilled in the art. Simply because these solutions are described in the background technology section of this application, it should not be assumed that the above technical solutions are well known to those skilled in the art. Summary of the Invention

[0007] In order to solve at least one of the above problems and one or more of the other potential problems, the present disclosure proposes a multifunctional foreign body capture device and an operation method thereof, which are used to treat or provide minimally invasive intervention / implantation surgery (such as mitral valve, tricuspid valve clips, filters, etc.). During the operator's operation, due to improper operation, poor treatment effect or remedial measures after an unexpected situation occurs, the device can capture and remove the implant in an interventional manner.

[0008] In a first aspect of the present disclosure, a multifunctional foreign body capturing device is provided, which includes: a grasping assembly, which is arranged at the distal end of the above-mentioned grasping device and is a claw-shaped structure composed of three or more grasping arms, and a barb structure is provided at the same position at the distal end of each grasping arm, and the barb structure is constructed so that the barb tip faces the central axis of the above-mentioned grasping assembly, and the barb structure is arranged as an outward protruding structure with the root connected to the grasping arm and bent from the distal end to the proximal end; a folding assembly, which is arranged as a sleeve structure and can be displaced relative to the above-mentioned grasping assembly, and when the above-mentioned folding assembly moves from the proximal end to the distal end, the above-mentioned folding assembly squeezes the above-mentioned grasping arm from the proximal end through the inner wall so that the above-mentioned grasping assembly is gradually folded into the above-mentioned folding assembly; a conveying assembly, which is arranged to connect the above-mentioned grasping assembly and the above-mentioned folding assembly at the distal end and to connect the above-mentioned grasping assembly and the above-mentioned folding assembly at the proximal end to operate the above-mentioned grasping assembly and the above-mentioned folding assembly at the proximal end.

[0009] Furthermore, in some embodiments, the grabbing assembly is configured to be made of memory metal, and the claw-shaped structure composed of the grabbing arm is configured to gradually open from the proximal end to the distal end of the grabbing arm when not retracted.

[0010] Furthermore, in some embodiments, the grabbing assembly is configured to consist of a claw base and the grabbing arm directly extending from the proximal end to the distal end of the claw base.

[0011] Furthermore, in some embodiments, the capture arm is configured to include: a curved section connected to the distal end of the claw base; and an extension section connected to the distal end of the curved section.

[0012] Furthermore, in some embodiments, a barb window is provided near the distal end of the capture arm, which passes through the inner and outer surfaces of the capture arm, and the root of the barb structure extends from the side wall on the distal side of the barb window, and the barb structure faces the central axis of the capture assembly.

[0013] Furthermore, in some embodiments, when the grabbing assembly is folded or opened, the plurality of barb tips are located on the same circular surface, and the central axis of the grabbing assembly is configured to pass vertically through the center of the circular surface.

[0014] Furthermore, in some embodiments, the claw base of the grabbing assembly is configured as a tubular structure, and the tubular structure of the claw base can be sleeved on an inner tube assembly, and the inner tube assembly is configured to be equipped with a release member and a snare cutting member.

[0015] In the second aspect of the present disclosure, a method for operating a foreign object capturing device as described above is also provided, and the operating method includes the following steps: operating the foreign object capturing device so that the distal end of the grasping component retracted in the retracting component approaches the target clamp; operating the foreign object capturing device so that the retracting component moves from the distal end to the proximal end so that the grasping arm of the retracted grasping component gradually opens; operating the foreign object capturing device so that the proximal end of the retracting component with the grasping arm opened approaches the target part of the target clamp and operating the foreign object capturing device so that the retracting component moves from the proximal end to the distal end so that the grasping arm of the grasping component with the grasping arm opened gradually closes.

[0016] Furthermore, in some embodiments, the operating method also includes: after determining that the distal inner surface of the capture arm of the above-mentioned folding assembly is in contact with the target part of the target clamp, the capture arm of the above-mentioned folding assembly is further folded by operating the above-mentioned foreign matter capture device and the barb structure is embedded in the target part of the target clamp, and at the same time, the above-mentioned foreign matter capture device is operated to move the above-mentioned capture assembly as a whole toward the proximal end so that the barb tip is further embedded in the target part of the target clamp.

[0017] Furthermore, in some embodiments, the operating method includes: determining that the distal inner surface of the grabbing arm of the above-mentioned folding assembly is in contact with the base of the forming ring clamp; the above-mentioned operating method further includes: operating the above-mentioned foreign matter capturing device to further fold the grabbing arm of the above-mentioned folding assembly and embed the barb structure into the gap facing the distal end surface of the base of the forming ring clamp, and at the same time operating the above-mentioned foreign matter capturing device to move the above-mentioned grabbing assembly as a whole toward the proximal end so that the barb tip is further embedded in the gap facing the distal end surface of the base of the forming ring clamp and the central axis of the above-mentioned grabbing assembly coincides with the central axis of the base of the above-mentioned forming ring clamp.

[0018] Furthermore, in some embodiments, the operating method includes: determining that the distal inner surface of the capture arm of the above-mentioned folding assembly is in contact with the clamping arm of the edge-to-edge clamp; the above-mentioned operating method further includes: operating the above-mentioned foreign matter capture device to further fold the capture arm of the above-mentioned folding assembly and embed the barb structure into the gap on the outer surface of the clamping arm of the edge-to-edge clamp, and at the same time operating the above-mentioned foreign matter capture device to move the above-mentioned capture assembly as a whole toward the proximal end so that the barb tip is further embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp.

[0019] Compared with the prior art, the present disclosure has at least the following beneficial effects: In some embodiments, a gripping assembly is provided at the distal end of the gripping device, which forms a claw-shaped structure to more easily grip the target object; further, a barb structure is provided at the same position at the distal end of each gripping arm, and the barb structure is constructed so that the barb tip faces the central axis of the gripping assembly, and the barb structure is provided so that the root is connected to the gripping arm, and the outward protrusion structure bent from the distal end of the barb structure to the proximal end of the barb structure enables the gripping device to more easily (with a higher tolerance) accurately align and grip the target object, and then more conveniently perform the release operation of the release member or the cutting and disengagement operation of the loop cutter. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above and other features and advantages of the embodiments of the present disclosure will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings, in which: Figure 1 A schematic diagram showing a valve clipper at a corresponding position in the heart is shown; Figure 2 A schematic diagram showing another valve clipper at a corresponding position in the heart is shown; Figure 3 A schematic diagram showing another valve clipper at a corresponding position in the heart is shown; Figure 4 A schematic diagram of a multifunctional foreign body capturing device according to an embodiment of the present disclosure is shown; Figure 5 shows a schematic diagram of a gripping assembly according to an embodiment of the present disclosure when it is opened; Figure 6 shows a schematic diagram of a gripping assembly according to an embodiment of the present disclosure when being folded; Figure 7 A schematic diagram showing an angle of a gripping assembly according to an embodiment of the present disclosure is shown; Figure 8 A schematic diagram showing another angle of a gripping assembly according to an embodiment of the present disclosure is shown; Figure 9 A schematic diagram showing another angle of a gripping assembly according to an embodiment of the present disclosure; Figure 10 A schematic diagram showing another angle of the grab assembly according to an embodiment of the present disclosure Figure 11 shows a schematic diagram of an approach forming ring clamp according to an embodiment of the present disclosure; Figure 12 A schematic diagram illustrating a release forming ring clamp according to an embodiment of the present disclosure is shown; Figure 13 A method for operating a foreign body capturing device according to an embodiment of the present disclosure is shown. Figure 14shows a schematic diagram of an edge-to-edge clamp approaching according to an embodiment of the present disclosure; Figure 15 A schematic diagram showing a snare cutter cutting according to an embodiment of the present disclosure; Figure 16 Another method of operating a foreign matter capturing device according to an embodiment of the present disclosure is shown; Figure 17 A manufacturing aid diagram showing a gripping assembly according to an embodiment of the present disclosure; and In the various drawings, the same or corresponding reference numerals denote the same or corresponding parts. DETAILED DESCRIPTION

[0021] Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although certain embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be construed as being limited to the embodiments described herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present disclosure. It should be understood that the drawings and embodiments of the present disclosure are for illustrative purposes only and are not intended to limit the scope of protection of the present disclosure.

[0022] In the description of the embodiments of the present disclosure, the term "including" and similar terms should be understood as open inclusion, that is, "including but not limited to." The term "based on" should be understood as "based at least in part on." The term "one embodiment" or "the embodiment" should be understood as "at least one embodiment." The terms "first," "second," etc. may refer to different or the same objects. Other explicit and implicit definitions may also be included below.

[0023] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0024] It should be understood that although the terms first, second, third, etc. may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "at the time of" or "when" or "in response to determining".

[0025] In addition, it should be noted that, in the description of the embodiments of this application, unless otherwise explicitly defined, "in vivo" means inside the patient's tissues and organs, and "in vitro" means outside the patient's tissues and organs. At the same time, in the embodiments of this application, "distal" refers to the direction away from the physician, and "proximal" refers to the direction toward the physician. It should also be understood that the "outward" in the "outwardly protruding structure" in this disclosure refers to the direction away from the central axis of the grasping assembly, while the corresponding "inward" refers to the direction toward the central axis of the grasping assembly.

[0026] Generally, some technical solutions that have been queried have proposed a recyclable valve clamp and a valve clamp recovery system. In particular, the valve clamp (edge-to-edge clamp) removal design mentioned in the patent requires the clamp itself to have features (hooks, barbs, rings, blind holes, through holes, magnetic parts, screw threads and other connection features). However, in the design of more clamps (for example, forming ring clamps, etc.), for the protection and treatment of the patient's heart, the product features will be designed to be as smooth as possible to avoid the existence of special-shaped features; the product will be coated with a polymer film to accelerate the process of cardiac endothelialization and reduce the possibility of damage to the heart itself; and the connection features require the control of the delivery system to achieve precise alignment operation. The interventional approach control itself is difficult, and achieving precise alignment is even more difficult to achieve. It should be understood that valve clippers (generally classified as A61F) and valve clip retrieval systems (generally classified as A61B) are generally two separate devices, wherein the valve clipper can be implanted in the human body as a prosthesis, while the independent valve clip retrieval system is a specialized device for removing foreign objects from the human body (similar to surgical forceps, surgical clamps, etc.). It should also be noted that simply because a valve clipper is involved, the corresponding device (e.g., a valve clip retrieval system) does not necessarily fall under the valve clipper classification; this is similar to how denture extraction forceps (retrieval devices) do not necessarily fall directly under the denture classification, nor does a vehicle engine retrieval device necessarily fall under the engine classification, unless the denture extraction forceps (retrieval device) are a component of the specialized denture, and the retrieval device is a component of the specialized engine. Of course, both the valve clipper (generally classified into A61F) and the valve clipper recovery system (generally classified into A61B) belong to the "biomedical engineering industry" among the strategic emerging industries.

[0027] In other applications, such as for atrial septal defects (a type of congenital heart disease), which are abnormal openings in the septum between the heart's two atria, blood flow can be disrupted, increasing cardiac stress or causing other symptoms. Where anatomical structures permit, an atrial septal occluder is typically implanted to fill the defect and close the abnormal blood flow pathway within the heart, preventing blood from shunting from the left atrium to the right atrium (ASD) or preventing venous thrombi and other substances from entering the arterial system through the patent foramen ovale (PFO-related stroke / embolism), thereby alleviating cardiac stress. This is currently a commonly used minimally invasive treatment option, but it carries the risk of poor treatment efficacy, poor placement, and device malfunction due to product and device issues and operator errors. In the event of an adverse event, removal is currently only possible through surgical thoracotomy, which is extremely traumatic for the patient.

[0028] In other application scenarios, filters (usually inferior vena cava filters) are primarily used to prevent deep vein thrombosis in the lower extremities from dislodging and entering the pulmonary arteries with the bloodstream, potentially leading to fatal pulmonary embolism (PE). When effective anticoagulation is unavailable, these filters provide a physical barrier for high-risk patients, intercepting large blood clots from the lower extremities / pelvis and preventing fatal PE. Filters can be categorized as retrievable or permanent, and must be removed on schedule within the implantation period. Furthermore, improper filter implantation or, in exceptional circumstances, inability / difficulty in removal can pose significant risks to the patient, necessitating surgical intervention.

[0029] It should be understood that implant failures due to instrumentation and operator reasons, which require removal, are described as foreign bodies in the various embodiments of this disclosure. In particular, the multifunctional foreign body capture device in the various embodiments herein is a relatively universal (adaptable to at least Figure 1-3 A device for removing foreign bodies from the human body (for removing implanted devices) can at least solve the following problems: Figure 1-3 When the clip or corresponding prosthesis involved in the procedure fails (when implanted incorrectly or with other problems), it can be used as a specialized removal device with good versatility to remove the failed or problematic clip (the failed prosthesis can be considered as an inappropriate foreign body left in the human body).

[0030] To address at least one of the aforementioned issues, as well as one or more of other potential issues, exemplary embodiments of the present disclosure provide a multifunctional foreign body capture device and a corresponding operating method thereof, which are described below with reference to the accompanying drawings.

[0031] Figure 1 、 2 3 shows a schematic diagram of the valve clip in the corresponding position of the heart. Figures 1 to 3In order to meet the demand for clamps in the clinic, the present invention proposes a multifunctional foreign body capturing device, which can remove the corresponding clamps through interventional surgery.

[0032] Figure 4 A schematic diagram of a multifunctional foreign body capture device according to an embodiment of the present disclosure is shown. In this exemplary embodiment, the multifunctional foreign body capture device 100 includes: a grasping assembly 10, which is disposed at the distal end of the grasping assembly 100; a retraction assembly 20, which is configured as a sleeve structure and is used to gradually retract the grasping assembly 10 into the retraction assembly 20; and a conveying assembly 30, the distal end of which is connected to the grasping assembly 10 and the retraction assembly 20, and the proximal end of which is connected to an operating assembly 40 for operating the grasping assembly 10 and the retraction assembly 20. It should also be understood that in this illustrated embodiment, the specific operating assembly 40 further includes: an emptying valve 41, a bending control knob 42, a telescoping knob 43, and a push-pull knob 44; in addition, a Y-valve 51 and a lockable hemostasis valve 52 are also included.

[0033] It should be understood that the grabbing assembly 10 is a key component of the grabbing device 100 , which will be further described below.

[0034] Figure 5 A schematic diagram of an expanded gripping assembly according to an embodiment of the present disclosure is shown. In this exemplary embodiment, the gripping assembly 10 is disposed at the distal end of the gripping device 100 and comprises a claw-shaped structure consisting of three or more (preferably six in the illustration) gripping arms 11. Each gripping arm 11 is provided with a barb structure 15 at the same distal end. The barb structure 15 is configured with its tip facing the central axis of the gripping assembly 10. The barb structure 15 is connected to the gripping arm 15 at its base (illustrated near the distal end of the gripping arm 11) and is configured as an outwardly protruding structure that curves from the distal end to the proximal end (i.e., the curve is directed away from the central axis of the gripping assembly 10). It should also be understood that the central axis of the gripping assembly 10 refers to the tubular structure (or cylindrical structure when viewed from the outside) of the retraction assembly 20 and the conveying assembly 30, as shown in the illustration. Accordingly, the central axis (similar to the central axis of a cylinder) can be a fictitious straight line passing through the center of the bottom circular surface.

[0035] Figure 6 A schematic diagram of a gripping assembly according to an embodiment of the present disclosure is shown when being retracted. In this exemplary embodiment, the gripping assembly 10 is retracted within the retraction assembly 20. It should be understood that the retraction assembly 20 is configured as a sleeve structure and is capable of displacement relative to the gripping assembly 10. As the retraction assembly 20 moves from the proximal end to the distal end (from right to left in the illustration), the gripping assembly 10 is gradually retracted and placed within the retraction assembly 20.

[0036] Figure 7A schematic diagram of an angle of a gripping assembly according to an embodiment of the present disclosure is shown. In this exemplary embodiment, the gripping assembly 10 is configured to consist of a claw base 12 and a gripping arm 11 extending directly from the proximal end to the distal end of the claw base 12. Furthermore, in some embodiments, the gripping arm 11 is configured to include: a curved section 11-2 connected to the distal end of the claw base 12; and an extension section 11-1 connected to the distal end of the curved section 11-2. Furthermore, in some embodiments, a barb window 16 is provided near the distal end of the gripping arm 11, which passes through the inner and outer surfaces of the gripping arm, and the root of the barb structure 15 extends from the side wall on the distal side of the barb window 16, and the barb structure 15 faces the central axis of the gripping assembly 10.

[0037] Figure 8 A schematic diagram of another angle of the gripping assembly according to an embodiment of the present disclosure is shown. In this exemplary embodiment, when the gripping assembly 10 is naturally closed or opened (not performing a gripping operation or being pushed or stretched by an external force), the multiple barbed tips are located on the same circular surface, such as Figure 9 As shown, the center axis of the grabbing assembly 10 is arranged to pass vertically through the center of the circular surface. Figure 9 The middle is the vertical paper. In addition, Figure 10 A schematic diagram showing a gripping assembly according to an embodiment of the present disclosure from another angle is shown, which is a perspective view of the gripping assembly 10 .

[0038] Furthermore, in some embodiments, the above-mentioned grasping component 10 is configured to be composed of memory metal (for example, made of superelastic nickel-titanium alloy, which retains the characteristics of elastic deformation after heat setting treatment), and when the claw-shaped structure composed of the grasping arm 11 is not folded, it is configured to gradually open from the proximal end to the distal end of the above-mentioned grasping arm.

[0039] It should also be understood that in some embodiments, the capture device 100 can be matched with some operable accessories (such as release pieces, snare cutters), and the above-mentioned operable accessories can be delivered to the target position through the inner cavity of the capture device 100 to perform auxiliary capture operations, and the target objects that can be captured include not only clamps, but also occluders, filters, etc.

[0040] Furthermore, the operation method of the above-mentioned capture device in some specific application scenarios is introduced.

[0041] against Figure 1 The application scenarios of the forming ring clamp in the embodiment can be operated in the following ways.

[0042] In some embodiments, a method for operating a foreign body capture device is provided, the method 1000 comprising the following steps: Step 1100, operating the foreign body capture device 100 so that the distal end of the capture assembly retracted within the retracting assembly approaches the target clamp, i.e., Figure 11The forming ring clamp 110 shown in FIG. 1 is a diagram of a forming ring clamp 110; step 1200, by operating the foreign body catching device 100, the folding assembly is moved from the distal end to the proximal end so that the catching arm of the folded catching assembly is gradually opened; step 1300, by operating the foreign body catching device 100, the proximal end of the folding assembly with the catching arm opened is brought close to the base portion of the forming ring clamp 110, and by operating the foreign body catching device 100, the folding assembly is moved from the proximal end to the distal end so that the catching arm of the catching assembly with the catching arm opened is gradually folded; step 1400, determining the distal end of the catching arm of the folding assembly. The surface contacts the distal end of the base of the forming ring clamp 110; step 1500, by operating the above-mentioned foreign body capturing device 100, the capturing arm of the above-mentioned retraction assembly is further retracted and the barb structure is embedded in the gap facing the distal end face of the base of the forming ring clamp 110, and at the same time, by operating the above-mentioned foreign body capturing device 100, the above-mentioned capturing assembly is moved toward the proximal end as a whole (the technical effect of this is that the barb tip is further embedded in the gap facing the distal end face of the base of the forming ring clamp 110 and the central axis of the above-mentioned capturing assembly coincides with the central axis of the base of the above-mentioned forming ring clamp). It should be understood that, generally, it is easy to grasp the outer surface of the forming ring clamp 110 with the claw structure of the grasping assembly of the foreign body capturing device 100. However, it is not easy to send the releasing member to the capturing position through the inner tube and just release the forming ring clamp 110. The core difficulty is that the extended releasing member needs to be "facing" the proximal end of the base of the forming ring clamp 110 (the so-called facing means that the central axis of the releasing member coincides with the central axis of the distal end surface of the base of the captured forming ring clamp 110).It should be understood that it is challenging to fine-tune the distal end of the foreign body capture device 100 to face the base of the forming ring clamp 110 only by means of ultrasound assistance or other methods. The operating method 1000 is combined with the unique barb structure of the foreign body capture device 100. The foreign body capture device 100 can be operated so that the grasping component initially grasps the forming ring clamp 110 (including its base portion in the claw) and the barb structure penetrates the outer membrane of the forming ring clamp 110. At this time, the foreign body capture device 100 may have a certain inclination angle relative to the base of the forming ring clamp 110 (the central axis of the foreign body capture device 100 and the forming ring clamp 110 do not coincide). Then, by operating the foreign body capture device 100, the grasping component can be grasped. As the entire assembly moves proximally (i.e., the grasping assembly of the rear-pull foreign body capture device 100), since some of the deflected barb structures only initially penetrate the outer membrane of the forming ring clamp 110 (particularly the gap at the distal end of its base), the grasping assembly of the rear-pull foreign body capture device 100 can cause the barb structures to move proximally relative to the forming ring clamp 110. Some of the barb structures closer to the distal end will first encounter the obstruction of the distal end surface of the base of the forming ring clamp 110 and stop, until all the remaining barb structures are obstructed by the distal end surface of the base of the forming ring clamp 110, thereby causing the central axis of the grasping assembly to coincide with the central axis of the base of the forming ring clamp 110. It should be further understood that it is precisely because of the following. Figure 7 The barb structure is particularly provided with a barb window 16 penetrating the inner and outer surfaces of the capture arm near the distal end of the capture arm 11, the root of the barb structure 15 extends from the side wall of the distal end of the barb window 16, and the barb structure 15 faces the central axis of the capture component 10; and the barb structure 15 is constructed so that the barb tip 15-1 faces the central axis of the capture component, so that the capture component of the foreign body capture device 100 is not intended to penetrate the base of the forming ring clamp 110 (damage the end face of the base), but is pulled back as the capture component of the foreign body capture device 100 is operated. The front end portion of the barb structure 15 near the barb tip 15-1 is made to be a surface larger than the point (barb tip) to resist (stationary, not piercing and moving together toward the proximal end) the base end face of the forming ring clamp 110 as a whole, and the other capturing arms of the grasping assembly of the foreign body capturing device 100 are fully given the opportunity to adjust their posture (move toward the proximal end), and finally the barbs on all the capturing arms of the grasping assembly of the foreign body capturing device 100 are made to stay on the base end face of the forming ring clamp 110, thereby achieving the coincidence of the central axis of the grasping assembly and the central axis of the base of the forming ring clamp. Subsequently, the distal end face of the subsequent release member can be aligned with the proximal end face of the base of the forming ring clamp 110, that is, the release member can be inserted into the forming ring clamp 110 to perform the release operation on the forming ring clamp 110, as shown in FIG. Figure 12 As shown. Figure 12In the figure above, the shaping ring clamp 110 is opened by using the release member to release the clamped human tissue, while the figure below is the shaping ring clamp 110 being folded together and taken out of the human body through the foreign body capture device 100. In addition, Figure 13 A method of operating a foreign matter capturing device according to an embodiment of the present disclosure is shown.

[0043] against Figure 2 The application scenarios of the edge-to-edge clamp in the embodiment of the present invention can be achieved through the following operation methods.

[0044] In some embodiments, a method for operating a foreign body capture device is provided, the method 2000 comprising the following steps: Step 2100, operating the foreign body capture device 100 so that the distal end of the capture assembly retracted within the retracting assembly approaches the target clamp, i.e., Figure 14 The edge-to-edge clamp 120 shown; step 2200, by operating the above-mentioned foreign body capturing device 100, the above-mentioned folding component is moved from the distal end to the proximal end so that the catching arm of the folded catching component is gradually opened; step 2300, by operating the above-mentioned foreign body capturing device 100, the proximal end of the folding component with the catching arm opened is close to the supporting arm part of the edge-to-edge clamp 120, and by operating the above-mentioned foreign body capturing device 100, the above-mentioned folding component is moved from the proximal end to the distal end so that the catching arm of the catching component with the catching arm opened is gradually folded; step 2400, it is determined that the distal inner surface of the catching arm of the above-mentioned folding component is in contact with the clamping arm of the edge-to-edge clamp 120; step 2500, by operating the above-mentioned foreign body capturing device 100, the catching arm of the above-mentioned folding component is further folded and the barb is embedded in the clamping arm of the edge-to-edge clamp 120 and at the same time, by operating the foreign body capturing device 100, the capturing assembly is moved proximally as a whole so that the barb tip is further embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp (the technical effect of this is that the capturing arm that has embedded the barb in the gap on the outer surface of the clamping arm of the edge-to-edge clamp 120 is stationary relative to the edge-to-edge clamp 120 when pulled back, while the capturing arm that has not been embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp 120 can be embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp 120 after adjustment (after the pulling back operation), so that the foreign body capturing device 100 can firmly grasp the edge-to-edge clamp 120, and thereafter, a snare cutter is delivered from the inner tube (which can be cut by an electric knife, which can be a radiofrequency electric knife, a high-frequency electric knife, etc.), the snare cutter is as follows Figure 15 As shown, the human tissue is cut along the capture arm (inside the capture arm) to achieve the detachment of the edge-to-edge clamp 120. Then, the edge-to-edge clamp 120 can be further compressed by adjusting the foreign body capture device 100 and removed together with the foreign body capture device 100. Figure 16Another method of operating a foreign matter capturing device according to an embodiment of the present disclosure is shown.

[0045] In addition, for Figure 3 The application scenario of the edge-to-edge clamp in the method 2000 can also include an operation method similar to method 2000.

[0046] In addition, the present disclosure also provides a method for manufacturing the grabbing assembly of the foreign body grabbing device in the above embodiment, wherein Figure 17 The middle is an expanded view of a tubular structure such as the claw base of a gripping assembly (but the length includes the entire length of the claw base and the gripping arm), that is, the tubular structure is cut from one side wall along the central axis of the claw base and laid out flat. Laser cutting is performed on the tubular structure as shown in the figure, leaving Figure 17 The remaining material, including the claw base portion on the right end of the paper, the capture arm on the left end of the paper and the barb window and barb structure (including the barb tip) at the distal end of the capture arm can be cut out by laser. Furthermore, the guide wire can be moved from the barb tip portion of the barb window from the outside of the capture assembly to the inside of the capture assembly; the so-called inside refers to the side facing the central axis of the capture assembly, while the outside refers to the side facing away from the central axis of the capture assembly relative to the inside; thus, after high-temperature solidification, the barb structure of the present disclosure and the structure with the barb tip facing the central axis of the capture assembly are formed. It should also be understood that the barb window, in addition to being a byproduct of the manufacture of the barb structure, can also serve as a space for accommodating the bulging covering film when the barb pierces the covering film of the clamp, etc., guiding the excess covering film or extruded covering film to be extruded from the barb window and extend to the outer surface of the distal end of the capture arm of the capture assembly, thereby covering and protecting the outer surface of the distal end of the capture arm, thereby facilitating a more friendly removal operation to the organ wall.

[0047] While various embodiments of the present disclosure have been described above, the foregoing description is intended to be illustrative, non-exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or technological improvements in the marketplace, or to enable others skilled in the art to understand the embodiments disclosed herein.

[0048] The foregoing description is merely an optional embodiment of the present disclosure and is not intended to limit the present disclosure. Those skilled in the art will readily appreciate that the present disclosure is susceptible to various modifications and variations. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present disclosure shall be included within the scope of protection of the present disclosure.

Claims

1. A multifunctional foreign body capturing device, characterized in that: include: A gripping assembly is provided at the distal end of the gripping device and is a claw-shaped structure composed of three or more gripping arms. A barb structure is provided at the same position at the distal end of each gripping arm. The barb structure is configured so that the barb tip faces the central axis of the gripping assembly. The barb structure is provided as an outwardly protruding structure with the root connected to the gripping arm and curved from the distal end to the proximal end. The retracting assembly is configured as a sleeve structure and is displaceable relative to the grasping assembly. When the retracting assembly moves from the proximal end to the distal end, the retracting assembly squeezes the grasping arm from the proximal end through the inner wall so that the grasping assembly is gradually retracted and enters the retracting assembly. The conveying assembly is configured to be connected to the grasping assembly and the folding assembly at a distal end and to be connected to an operating assembly for operating the grasping assembly and the folding assembly at a proximal end.

2. The foreign body capturing device according to claim 1, characterized in that: The grabbing assembly is configured to be made of memory metal, and the claw-shaped structure composed of the grabbing arms is configured to gradually open from the proximal end to the distal end of the grabbing arms when not folded.

3. The foreign body capturing device according to claim 2, characterized in that: The grabbing assembly is configured to consist of a claw base and the grabbing arm directly extending from the proximal end to the distal end of the claw base.

4. The foreign body capturing device according to claim 3, characterized in that: The capture arm is configured to include: a curved section connected to a distal end of the claw base; and an extension section connected to a distal end of the curved section.

5. The foreign body capturing device according to claim 2, characterized in that: A barb window is provided near the distal end of the capture arm, which passes through the inner and outer surfaces of the capture arm. The root of the barb structure extends from the side wall of the distal end of the barb window, and the barb structure faces the central axis of the capture assembly.

6. The foreign body capturing device according to claim 2, characterized in that: When the grabbing assembly is folded or opened, the plurality of barb tips are located on the same circular surface, and the central axis of the grabbing assembly is arranged to pass vertically through the center of the circular surface.

7. The foreign body capturing device according to claim 1, characterized in that: The claw base of the grabbing assembly is configured as a tubular structure, and the tubular structure of the claw base can be sleeved on an inner tube assembly. The inner tube assembly is configured to be equipped with a releasing member and a snare cutting member.

8. A method for operating the foreign body capturing device according to any one of claims 1 to 7, characterized in that: include: By operating the foreign body capturing device, the distal end of the capturing assembly retracted within the retracting assembly is brought close to the target clamp; By operating the foreign body capturing device, the retracting assembly is moved from the distal end to the proximal end so that the capturing arm of the retracted capturing assembly is gradually opened; By operating the foreign body capturing device, the proximal end of the folding assembly with the capturing arm opened is brought close to the target part of the target clamp, and by operating the foreign body capturing device, the folding assembly is moved from the proximal end to the distal end, so that the capturing arm of the capturing assembly with the capturing arm opened is gradually folded.

9. The operating method according to claim 8, characterized in that: Also includes: After determining that the distal inner surface of the capture arm of the folding assembly is in contact with the target part of the target clamp, the capture arm of the folding assembly is further folded by operating the foreign body capture device and the barb structure is embedded in the target part of the target clamp. At the same time, the capture assembly is moved proximally as a whole by operating the foreign body capture device so that the barb tip is further embedded in the target part of the target clamp.

10. The operating method according to claim 8, characterized in that: The step of determining that the distal inner surface of the capture arm of the retraction assembly contacts the target portion of the target clamp comprises: ensuring that the distal inner surface of the catch arm of the retraction assembly contacts the base of the forming ring clamp; The operating method further comprises: By operating the foreign body catching device, the catching arm of the folding assembly is further folded and the barb is embedded in the gap facing the distal end surface of the base of the forming ring clamp, and at the same time, by operating the foreign body catching device, the catching assembly is moved proximally as a whole so that the barb tip is further embedded in the gap facing the distal end surface of the base of the forming ring clamp and the central axis of the catching assembly coincides with the central axis of the base of the forming ring clamp.

11. The operating method according to claim 8, characterized in that: The step of determining that the distal inner surface of the capture arm of the retraction assembly contacts the target portion of the target clamp comprises: ensuring that the distal inner surface of the capture arm of the stowing assembly contacts the clamping arm of the edge-to-edge clamp; The operating method further comprises: By operating the foreign body catching device, the catching arm of the folding assembly is further folded and the barb structure is embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp, and at the same time, by operating the foreign body catching device, the catching assembly is moved proximally as a whole so that the barb tip is further embedded in the gap on the outer surface of the clamping arm of the edge-to-edge clamp.

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