Closure device and closure system

Abstract

The application discloses a plugging device for plugging an intracranial sphenoid sinus, the plugging device having a contracted configuration for delivery and a predetermined expanded configuration, the plugging device comprising: a distal anchoring structure comprising a resilient anchor for anchoring to a distal side of a floor of the sphenoid sinus; a proximal plugging disc arranged on a proximal side of the floor of the sphenoid sinus for plugging an opening in the floor of the sphenoid sinus; and a connecting portion having a distal end connected to the distal anchoring structure and a proximal end connected to the proximal plugging disc, the connecting portion having an outer diameter suitable for the size of the opening in the floor of the sphenoid sinus; wherein in the contracted configuration, the outer side of the resilient anchor is further away from the proximal plugging disc than the central region; the resilient anchor can be spread outwards and anchored to the floor of the sphenoid sinus, and during the spreading process, the resilient anchor has a certain distance from intracranial nerves and does not cause damage to the intracranial nerves.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an occluder and an occlusion system. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] In the past decade, with the development of neurosurgical techniques and related equipment, as well as the rapid rise and popularization of minimally invasive techniques, transsphenoidal approach surgery in minimally invasive neurosurgery has been gradually and widely used in tumor surgery in many areas of the skull base. Due to its advantages such as being minimally invasive, safe, and having good efficacy, transsphenoidal approach surgery has been widely recognized.

[0004] Transsphenoidal surgery involves using a neuroendoscopy to access the sphenoid sinus through a single nostril and nasal passage. This allows for extensive bone removal of the anterior wall of the sphenoid sinus, as well as bone removal or resection of the posterior wall where a tumor may be located. It is a minimally invasive surgical method, allowing for comprehensive endoscopic visualization of the tumor, facilitating accurate diagnosis and effective resection. The transsphenoidal approach is minimally invasive, simple to perform, and short in duration, resulting in rapid recovery. It also preserves the sense of smell and eliminates the need for nasal septum dissection.

[0005] With the increasing number of patients with pituitary tumors and other intracranial diseases, people have gained a deeper understanding of the anatomical structure of the skull base. Since the projection outside the cranial cavity is exactly the sphenoid sinus, and the nasal cavity and sinuses are spaces that the human body naturally possesses, the transsphenoidal approach makes good use of these spaces as a surgical approach. The impact of surgery performed through this approach on the human body is far less than that of transcranial surgery. During the operation, it is necessary to grind or remove the bone of the posterior wall of the sphenoid sinus. After performing transsphenoidal surgery for pituitary tumors and other intracranial diseases, the sphenoid sinus needs to be sealed.

[0006] Current methods of occlusion involve placing an inflatable rubber pad or filling the sphenoid sinus with gelatin sponge and iodoform gauze. However, since these materials lack any external protective mechanisms, they are prone to causing neurovascular damage, bleeding, cerebrospinal fluid leakage, and sphenoid sinus infection, which are detrimental to the patient's recovery. Summary of the Invention

[0007] The objective of this invention is to at least solve the technical problem of easy intracranial nerve damage during the occlusion process. This objective is achieved through the following technical solution:

[0008] In a first aspect, the present invention provides an occluder for occluding the intracranial sphenoid sinus, the occluder having a contractile configuration for delivery and a predetermined expansion configuration, the occluder comprising:

[0009] The distal anchoring structure includes an elastic anchor for anchoring to the distal side of the floor wall of the sphenoid sinus.

[0010] A proximal occlusion disc is disposed on the proximal side of the floor wall of the sphenoid sinus and is used to seal the opening on the floor wall of the sphenoid sinus.

[0011] The connecting part has a distal end connected to the distal anchoring structure and a proximal end connected to the proximal occlusion disc. The connecting part has an outer diameter suitable for the size of an opening on the bottom wall of the sphenoid sinus.

[0012] In the contraction configuration, the outer side of the elastic anchor is further away from the proximal sealing disc than the central region.

[0013] In the occluder provided by this invention, a distal anchoring structure and a proximal occlusion disc are disposed on both sides of the floor wall of the sphenoid sinus. The distal anchoring structure is anchored to the distal side of the floor wall of the sphenoid sinus, and the proximal occlusion disc is disposed to the proximal side of the floor wall of the sphenoid sinus, thereby sealing the opening of the sphenoid sinus. The distal anchoring structure and the proximal occlusion disc are connected by the connecting part, so that the occluder is firmly fixed to the floor wall of the sphenoid sinus. The elastic anchor can open outward and is anchored to the floor wall of the sphenoid sinus. During the opening process, the elastic anchor maintains a certain distance from the intracranial nerves, so as not to cause damage to the intracranial nerves.

[0014] In some embodiments of the occluder of the present invention, the distal anchoring structure, the proximal occlusion disc, and the connecting portion are woven into an integral structure by braided wires, wherein the braided ends of the braided wires are gathered at the proximal end of the proximal occlusion disc.

[0015] In some embodiments of the occluder of the present invention, the distal anchoring structure, the proximal occlusion disc, and the connecting portion are all double-layered woven mesh structures made of the braided wires.

[0016] The elastic anchor is a ring-shaped structure, and the cross-section of the ring-shaped structure is a double-layer woven mesh.

[0017] The connection portion is formed by the double-layer woven mesh structure between the distal anchoring structure and the proximal sealing disc.

[0018] In some embodiments of the occluder of the present invention, the connecting portion has a first cavity, the distal end of the first cavity being connected to the inner ring of the elastic anchor, and the proximal end of the first cavity being connected to the interior of the proximal occlusion disc.

[0019] In some embodiments of the occluder of the present invention, the distal anchoring structure includes a plurality of elastic anchors arranged circumferentially at intervals, the proximal ends of the plurality of elastic anchors being fixedly connected to the connecting portion, and the distal ends of the plurality of elastic anchors being anchored to the distal side of the floor wall of the sphenoid sinus.

[0020] In some embodiments of the occluder of the present invention, a delivery ring is provided at the proximal end of the proximal occlusion disc.

[0021] The braided filaments at the convergence point of the braided mesh constituting the proximal sealing disc are folded back to form the conveying ring.

[0022] In some embodiments of the occluder of the present invention, the proximal occlusion disc is provided with the first occlusion membrane, the first occlusion membrane having an outer diameter consistent with the surface of the proximal occlusion disc, and a portion of the proximal occlusion disc is attached to the proximal side of the bottom wall of the sphenoid sinus.

[0023] In some embodiments of the occluder of the present invention, a second occlusion membrane is provided in the connecting part, the second occlusion membrane being used to block the opening of the sphenoid sinus.

[0024] In some embodiments of the occluder of the present invention, the proximal occlusion disc is woven from metal braided wire, the proximal occlusion disc is connected to the first occlusion membrane by a suture, and the connecting part is connected to the second occlusion membrane by a suture.

[0025] In some embodiments of the occluder of the present invention, the proximal occlusion disc is provided with an implantable adhesive, the adhesive being used to seal the gap between the proximal occlusion disc and the floor wall of the sphenoid sinus, as well as the gap between the first occlusion membrane and the floor wall of the sphenoid sinus;

[0026] And / or, the connecting portion is provided with an implantable adhesive, the adhesive being used to seal the gap between the connecting portion and the opening of the sphenoid sinus and the gap between the second occlusion membrane and the opening of the sphenoid sinus.

[0027] In some embodiments of the plugging device of the present invention, the conveying ring is also used to grab the plugging device and retrieve the plugging device.

[0028] A second aspect of the present invention provides a plugging system, the plugging system comprising:

[0029] The occluder as described in any of the preceding items;

[0030] The sheath, wherein the occluder is disposed within the sheath, wherein the distal anchoring structure and the proximal occluder disc are converging within the sheath;

[0031] A delivery wire, which is detachably connected to the proximal end of the proximal end sealing disc;

[0032] A conveyor rod, to which the conveyor wire is connected, is used to convey the plugging device. Attached Figure Description

[0033] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0034] Figure 1 The diagram schematically illustrates the occluder fixed to the floor wall of the sphenoid sinus according to an embodiment of the present invention;

[0035] Figure 2 A perspective view of a occluder according to one embodiment of the present invention is shown schematically;

[0036] Figure 3 A schematic front view of a occluder according to one embodiment of the present invention is shown;

[0037] Figure 4 A schematic cross-sectional view of a occluder according to another embodiment of the present invention is shown;

[0038] Figure 5 A perspective view of a clogging device according to another embodiment of the present invention is shown schematically;

[0039] Figure 6 A schematic diagram of the main body of a plugging device according to another embodiment of the present invention is shown;

[0040] Figure 7 The diagram schematically illustrates the occlusion system according to an embodiment of the invention releasing the occluder at the sphenoid sinus location;

[0041] Figure 8 A schematic diagram illustrating the state of the occluder fixed to the sphenoid sinus according to an embodiment of the present invention is shown.

[0042] Figure 9 The diagram schematically illustrates a closure device disposed within a sheath according to an embodiment of the present invention.

[0043] Figure 10 The diagram schematically illustrates a blocker disposed within a sheath according to an embodiment of the present invention, wherein the natural bending state of the elastic anchor extending out of the sheath is shown.

[0044] Figure 11The diagram schematically illustrates the state of an occluder disposed within a sheath according to an embodiment of the present invention, showing the state in which the elastic anchor extends out of the sheath and adheres to the floor wall of the sphenoid sinus.

[0045] Figure 12 A schematic diagram illustrating the state of a occluder disposed within a sheath according to another embodiment of the present invention is shown.

[0046] Figure 13 The diagram schematically illustrates a occluder disposed within a sheath according to an embodiment of the present invention, wherein an elastic anchor extends out of the sheath.

[0047] Figure 14 The diagram schematically illustrates the plugging device extending from the sheath in a plugging system according to an embodiment of the present invention;

[0048] Figure 15 The diagram schematically illustrates an occluder extending from its sheath in an occlusion system according to an embodiment of the present invention, wherein, after the delivery wire is withdrawn, the delivery ring adheres to the proximal occlusion disc.

[0049] Figures 16 to 20 The fabrication process of the occluder according to an embodiment of the present invention is illustrated schematically.

[0050] The attached figures are labeled as follows:

[0051] 100. Plugging device

[0052] 200. Sphenoid sinus; 210. Floor of the sphenoid sinus; 220. Opening.

[0053] 110. Remote anchoring structure; 111. Elastic anchor; 112. Circular structure; 113. Inner ring.

[0054] 120. Proximal occlusion disc; 121. First occlusion membrane; 122. Disc-shaped structure;

[0055] 130. Connecting part; 131. First cavity;

[0056] 140. Braided yarn; 141. Braided tube;

[0057] 150. Elastic anchor; 151. First anchoring end;

[0058] 160. Conveyor ring; 170. Steel sleeve;

[0059] 300, sealing system; 310, sheath; 320, delivery wire; 340, first sleeve;

[0060] 400, mold; 410, upper mold; 420, lower mold; 430, waist mold. Detailed Implementation

[0061] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0062] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0063] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0064] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0065] This invention provides an occluder for occluding the intracranial sphenoid sinus, and the occluder is fixed to the floor wall of the sphenoid sinus. The occluder includes a distal anchoring structure anchored to the distal side of the floor wall of the sphenoid sinus. One innovation of this invention is that the distal anchoring structure has an elastic anchor, which, in a contracted configuration (located within the sheath), is further proximally than in the central region, and at least a portion of the elastic occluder is anchored to the distal side of the floor wall of the sphenoid sinus.

[0066] The technical effect achieved by the above-mentioned innovation of the present invention is that when the occluder extends into the sphenoid sinus through the sheath, the distal end of the elastic anchor of the distal anchor can change from a contracted configuration to an expanded configuration after it extends out of the sheath. It does not need to extend a certain distance out of the sheath to unfold. Therefore, it will not damage the intracranial nervous system or blood vessels and other tissues, thus reducing harm to the patient.

[0067] The sealing device of the present invention will now be described in detail with reference to the accompanying drawings.

[0068] Example 1

[0069] Please see Figure 1 , Figure 7 and Figure 8 The occluder 100 of the present invention is disposed on the bottom wall 210 of the sphenoid sinus 200.

[0070] It can block the opening 220 of the sphenoid sinus 200, and the occluder 100 is delivered into the sphenoid sinus 200 through the nasal cavity within the sheath 310. The distal anchoring structure 110 of the occluder 100 can pass through the sphenoid sinus.

[0071] An opening 220 is located on the floor wall 210 of the sphenoid sinus 200 and anchored to the distal side of the floor wall 210 of the sphenoid sinus 200. Specifically, the distal anchor includes an elastic anchor 111. In the contraction configuration, the outer side of the elastic anchor 111 is further from the proximal end than the central region. The elastic anchor can be withdrawn from the contraction configuration immediately after protruding from the sheath.

[0072] The shape is restored to the extended configuration. Since the elastic anchor does not need to extend a certain distance from the sheath 310 to unfold after it extends from the sheath, it will not damage the intracranial nervous system or blood vessels and other tissues, thus reducing harm to the patient.

[0073] The occluder 100 of the present invention further includes a proximal occlusion disc 120 and a connecting portion 130. The proximal occlusion disc 120 is disposed on the proximal side of the bottom wall 210 of the sphenoid sinus 200 and is used to block the opening 220 of the sphenoid sinus 200;

[0074] The distal end of the connector 130 is connected to the distal anchoring structure 110, and the proximal end of the connector 130 is connected between the proximal occlusion discs 120. The connector 130 has an outer diameter suitable for the size of the opening 220 of the sphenoid sinus 200.

[0075] In Embodiment 1, the occluder 100, with its proximal occlusion disc 120, can seal the opening 220 on the floor wall 210 of the sphenoid sinus 200. The distal anchoring structure 110 is connected to the proximal occlusion disc 120 via a connecting part 130, further ensuring the occluder 100 is firmly fixed to the floor wall 210 of the sphenoid sinus 200.

[0076] In addition, the proximal occlusion disc 120 can also be attached to the proximal side of the bottom wall 210 of the sphenoid sinus 200 to block the opening 220 on the bottom wall 210 of the sphenoid sinus 2000, making the overall structure of the occluder 100 more robust.

[0077] The connecting part 130 also has an outer diameter suitable for the size of the opening 220 on the bottom wall 210 of the sphenoid sinus 200, which further reduces the possibility of relative positional changes between the occluder 100 and the sphenoid sinus 200.

[0078] Combination Figures 2 to 4 , Figures 9 to 11 As can be seen, in this embodiment, the occluder 100

[0079] It includes a distal anchoring structure 110, a proximal sealing plate 120, and a connecting part 130, wherein the distal anchoring structure 110, the proximal sealing plate 120, and the connecting part 130 are woven into a single structure by braided wires 140.

[0080] The constriction port of the integrated structure is located at the proximal end of the proximal occlusion disc 120; the distal anchoring structure 110, the proximal occlusion disc 120, and the connecting part 130, which are woven into an integrated structure by braided wires 140, have only one constriction port, and this constriction port is located at the proximal end of the proximal occlusion disc 120; the integrated structure occluder 100 has better stability. Since the constriction port is located at the proximal end of the proximal occlusion disc 120, and the distal anchoring structure 110 is woven into an integral structure by braided wires 140, damage to the floor wall 210 of the sphenoid sinus 200 can be avoided during or after the release of the distal anchoring structure 110.

[0081] The braided wire 140 can be made of shape memory material or elastic material metal. The metal wire material includes nickel-titanium alloy, nickel-titanium-cobalt alloy, cobalt-chromium alloy and other metal materials. Its wire diameter is between 0.0015 and 0.0035 inches, and the number of braided wires is between 32 and 72. The metal braided wire 140 has good support performance and can provide good support for the opening position to prevent the collapse of the bottom wall 210 of the sphenoid sinus 200.

[0082] The distal anchoring structure 110, the proximal occlusion disc 120, and the connecting portion 130 can all be configured as a double-layered braided mesh structure woven from braided wires 140. The elastic anchor 111 is a circular ring structure 112, the cross-section of which is a double-layered braided mesh. The double-layered braided mesh structure between the distal anchoring structure 110 and the proximal occlusion disc 120 converges to form the connecting portion 130. When the occluder 100 is placed inside the sheath 310, the disc surface of the circular ring structure 112 elastically deforms along the axial direction within the sheath 310, with the outer ring of the circular ring structure 112 extending distally. When the distal end of the occluder 100 just extends out of the sheath 310, the disc surface of the circular ring structure 112 can recover from a contracted configuration to an expanded configuration, requiring less space for release and avoiding damage to the nerves in the intracranial cavity. Figure 10 The diagram illustrates the natural bending state of the elastic anchor 111 after it extends out of the sheath. At this point, the elastic anchor 111 is not in contact with the floor wall 210 of the sphenoid sinus. Figure 10 It can be seen that after the elastic anchor 111 extends out of the sheath tube 210, it can return from the contracted configuration to the extended configuration; Figure 11 The illustration shows the state in which the elastic anchor 111 is fully extended from the sheath 210 and fits against the floor wall 210 of the sphenoid sinus. The elastic anchor 111 can be anchored at the distal end of the floor wall 210 of the sphenoid sinus.

[0083] The aforementioned occluder 100 has a two-disc, one-waist structure. It has a metal skeleton formed by a mesh structure woven from elastic metal wires and is pre-shaped through heat treatment. The two discs include an upper disc surface and a lower disc surface. When implanted, the upper disc surface is placed at the pituitary gland, and when implanted, the lower disc surface is placed at the bottom wall 210 of the sphenoid sinus 200. The upper disc surface is an elastic anchor 111, and the lower disc surface is a proximal occlusion disc 120.

[0084] The braided filament 140 is made of metal material with shape memory material or elastic material. Because the elastic material can maintain its original shape after heat treatment and shaping, it can fit fully with the bone around the opening after being unsheathed, reducing the risk of cerebrospinal fluid or blood leakage.

[0085] The woven mesh of the waist structure of the two-plate-one-waist structure can be pre-shaped according to the size of the opening 220 on the bottom wall 210 of the sphenoid sinus 200. If the opening 220 is small, the woven mesh of the waist structure is tightly axially arranged to form a bundled strip. If the opening is large, the woven mesh of the waist structure will be pre-shaped into a wider waist. The middle of the waist structure can also be sealed by suturing a second sealing membrane. In addition, the spiral structure of the waist can adapt to the size of the opening.

[0086] In this embodiment, the connecting portion 130 of the occluder 100 has a first cavity 131. The distal end of the first cavity 131 is connected to the inner ring 113 of the elastic anchor 111, and the proximal end of the first cavity 131 is connected to the interior of the proximal occlusion disc 120. The second occlusion membrane can be sutured in the connecting portion 130 through the inner ring 113 of the elastic anchor 111. The first occlusion membrane 121 can be placed into the proximal occlusion disc 120 through the inner ring 113 of the elastic anchor 111 and the first cavity 131 of the connecting portion 130, and connected to the proximal occlusion disc 120 through the suture.

[0087] A first occlusion membrane 121 is provided within the proximal occlusion disc 120. The first occlusion membrane 121 has an outer diameter consistent with the disc surface of the proximal occlusion disc 120. A portion of the proximal occlusion disc 120 is fitted against the proximal side of the bottom wall 210 of the sphenoid sinus 200. A second occlusion membrane is provided within the connecting portion 130, which is used to seal the opening 220 of the sphenoid sinus 200. The proximal occlusion disc 120 and the first occlusion membrane 121, and the connecting portion 130 and the second occlusion membrane are both connected by sutures.

[0088] The outer diameter of the first occlusion membrane 121 is consistent with the diameter of the proximal occlusion disc 120. The thickness of the first occlusion membrane 121 or the second occlusion membrane is between 10-150 μm, preferably 20-80 μm. The material of the first occlusion membrane 121 or the second occlusion membrane is a polymer material that can be tightly bonded to the implantable adhesive. The material includes polymer materials such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and polyamide (PA).

[0089] The suture material can be non-absorbable polymer materials such as nylon and polyester, and the diameter of the suture is between 0.03 and 0.5 mm.

[0090] The proximal occlusion disc 120 may be fitted with an implantable adhesive, which is used to seal the gaps between the proximal occlusion disc 120 and the bottom wall 210 of the sphenoid sinus 200, as well as between the first occlusion membrane 121 and the bottom wall 210 of the sphenoid sinus 200.

[0091] An implantable adhesive can also be provided on the connecting part 130. The adhesive is used to seal the gap between the connecting part 130 and the opening 220 of the sphenoid sinus 200, as well as between the second occlusion membrane and the opening 220 of the sphenoid sinus 200.

[0092] A mesh structure woven from elastic metal wires forms a metal skeleton with two discs and a waist. The metal skeleton provides a framework for the occlusion, ensuring that the device can be firmly installed at the opening. During the operation, after the distal anchoring structure 110 of the occluder 100 extends out of the sheath 310, it is necessary to start filling with implantable adhesive and then release the proximal occlusion disc 120 to ensure the occlusion effect of the connection 130. After releasing the proximal occlusion disc 120, glue is then filled around the proximal occlusion disc 120 and its edge to ensure the occlusion effect of the proximal occlusion disc 120.

[0093] Among them, implantable adhesives include: phosphate ester surgical adhesives, methacrylate surgical adhesives, cyanopropionate adhesives, and double-network medical surgical adhesives.

[0094] The proximal end of the proximal occlusion disc 120 is provided with a delivery ring 160. In one embodiment, the delivery ring 160 is formed by folding back the braided yarns at the gathering end of the braided mesh constituting the proximal occlusion disc 120. Please refer to [link to previous document]. Figure 18 The braided wires at the converging end of the proximal occlusion disc 120 first pass through the steel sleeve 170, then fold back once, and then pass through the steel sleeve 170 again to form a conveying ring 160, which secures the braided wires. The conveying ring 160 is also used to grip the occluder 100 and retrieve it.

[0095] The sphenoid sinus occluder 100 is primarily delivered via a delivery ring 160 at the proximal end of the proximal occlusion disc 120. The delivery ring 160 is pre-shaped into a ring structure through heat treatment. During delivery, a delivery wire 320 passes through the delivery ring 160 and, together with a delivery rod, pushes the occluder 100 out of the sheath 310. For release, one end of the delivery wire 320 is first untied, and then the device is pulled out from the other end. After release, the delivery ring 160, due to its shape, springs back and adheres to the proximal occlusion disc 120, effectively reducing the overall length and lowering the risk of intracranial injury to other tissues.

[0096] The 320 conveyor wire is a multi-strand wire, which is made of multiple outer monofilaments twisted around the central wire in a spiral shape. Its external shape is twisted. For the same external diameter, multi-strand wire is more flexible than monofilament wire. In addition, it has good bending strength and fatigue resistance. Multi-strand wire can be made of three or seven strands twisted together. Its external diameter is between 0.3mm and 0.5mm. The material is nickel-titanium alloy, cobalt-chromium alloy, stainless steel and other materials.

[0097] In this embodiment, the delivery ring 160 in the occluder 100 can also be used as a retrieval ring. By using the grabbing device to grab the ring opening and remove the adhesive around the occluder, it can be retrieved into the sheath 310. When the patient undergoes skull base surgery one year or more after the implantation of the sphenoid sinus 200 occluder, the sphenoid sinus 200 occluder can be retrieved by using the grabbing device in conjunction with the sheath 310, without the need for a second opening, reducing surgical time and facilitating skull base surgery.

[0098] The metal braided mesh tube is folded outward and shaped into a double-layer mesh structure. Firstly, it can reduce the number of nodes in the distal anchoring structure 110. Reducing the number of protruding nodes can prevent nerve tissue from being punctured when the sheath is unsheathed. Secondly, the upper plate can be folded outward through heat treatment and pre-shaping, so that the distal anchoring structure 110 can be unfolded in a narrow space when it is unsheathed.

[0099] The present invention also provides a method for manufacturing the above-mentioned plugging device 100, the method comprising:

[0100] The braided wires 140 are woven into a braided mesh tube, which is then fitted onto the outer wall of the first sleeve 340.

[0101] A portion of the braided mesh tube is placed inside the first sleeve 340, and the braided mesh tube is folded along the outer wall of the first sleeve 340 and fitted onto the outer wall of the first sleeve 340.

[0102] The braided mesh tube fitted onto the first sleeve 340 is designed as a double-layer braided mesh tube;

[0103] After the braided wire at one end of the opening 220 of the double-layer braided mesh tube is passed through the steel sleeve 170, it is folded back once and then inserted into the steel sleeve 170 to form a conveying ring 160.

[0104] The double-layer braided mesh tube connected to the conveying ring 160 is placed in the mold 400 and shaped into a sealing device 100.

[0105] The proximal occlusion disc 120 of the occluder 100 is embedded in the first occlusion membrane 121, and / or the connecting portion 130 is embedded in the second occlusion membrane;

[0106] like Figure 20 As shown, the mold 400 for making the plug 100 includes: an upper mold 410, a lower mold 420, and a waist mold 430.

[0107] Example 2

[0108] Example 2 provides an occluder. The similarities between the occluder in Example 2 and Example 1 will not be repeated. The main difference of the occluder in Example 2 is that the distal anchoring structure 110 includes a plurality of elastic anchors 150 arranged at intervals along the circumference. The proximal ends of the plurality of elastic anchors 150 are fixedly connected to the connecting part 130, and the distal ends of the plurality of elastic anchors 150 are anchored to the distal side of the bottom wall 210 of the sphenoid sinus 200.

[0109] The distal end of the elastic anchor 150 is also provided with a first anchoring end 151; the first anchoring end 151 contacts the bottom wall 210 of the sphenoid sinus 200. Since multiple first anchoring ends 151 are fixedly connected to the bottom wall 210 of the sphenoid sinus 200 in the circumferential direction, the connection between the elastic anchor 150 and the bottom wall 210 of the sphenoid sinus 200 is more secure.

[0110] The metal skeleton of the occluder 100 consists of two parts: a mesh structure woven from elastic metal wires and a laser-cut and shaped metal skeleton. It is pre-shaped into a two-disc, one-waist structure through heat treatment. The two discs include an upper disc surface and a lower disc surface. When implanted, the upper disc surface is placed at the pituitary gland, and when implanted, the lower disc surface is placed on the bottom wall 210 of the sphenoid sinus 200. The upper disc surface is laser-cut and shaped from metal, and the lower disc surface is shaped from metal woven mesh. The upper disc surface is the distal anchoring structure 110, and the lower disc surface is the proximal occlusion disc 120.

[0111] The distal anchoring structure 110 is formed by laser cutting of metal. For example, tubular metal materials such as nickel-titanium alloy, nickel-titanium-cobalt alloy, and cobalt-chromium alloy are cut off with a laser cutting machine to remove excess material. The remaining skeleton is then heat-treated to form an everted, inverted shape. The metal-cut skeleton has good stability, and after being everted, it can be effectively anchored at the opening position without moving. The everted structure can be safely deployed in narrow spaces, avoiding damage to the optic nerve or optic chiasm. In addition, it will not cause damage to the internal carotid artery and cavernous sinus due to compression of intracranial tissue during release, greatly reducing interference and impact on important intracranial neurovascular structures during surgery.

[0112] The connecting parts 130 are joined together by laser welding. The upper part of the metal mesh tube of the proximal sealing disc 120 is finished with a stainless steel sleeve, and the metal wires are bonded together using an argon arc welding machine. Then, the stainless steel sleeve is welded to the cut metal skeleton. For the delivery ring shaping, the tail end of the metal mesh tube is inserted into the stainless steel sleeve 170, and the braided wires are shaped into a loop. Then, the wire at the tail end is inserted into the stainless steel sleeve 170 and welded in place using a laser welding machine. The lower disc surface is also sewn with a coagulating sealing membrane, and the other end of the metal mesh tube is pre-shaped into a loop structure through heat treatment.

[0113] The present invention also provides an occlusion system 300, which includes an occluder 100 as described above, and further includes a sheath 310, a delivery wire 320, and a delivery rod. The occluder 100 is disposed within the sheath 310. The distal anchoring structure 110 and the proximal occlusion disc 120 are constricted within the sheath 310 after axial elastic deformation from the proximal end to the distal end. The delivery wire 320 is detachably connected to the proximal end of the proximal occlusion disc 120 and is connected to the delivery rod. The delivery rod is used to deliver the occluder 100 from the proximal end to the distal end.

[0114] During the surgery, the bone of the sphenoid sinus 200 floor wall 210 is ground away or removed. After the surgery via the sphenoid sinus 200 approach, an irregular opening will remain in the sphenoid sinus 200 floor wall 210. At this point, the device is used in this embodiment to reach the opening through the nasal cavity and sphenoid sinus 200 approach. First, the upper plate is pushed out. After the sheath 310 is pushed out, the upper plate will first unfold towards the periphery of the sheath 310 and then fold back to stably lock onto the bone around the opening. Because the pituitary gland and other nerve tissues are behind the sphenoid sinus 200 floor wall 210, the space behind the wall is relatively small. After the device is released from the sheath... The flipped structure can be safely deployed in narrow spaces, avoiding damage to the optic nerve or optic chiasm. In addition, it will not cause damage to the internal carotid artery and cavernous sinus due to compression of brain tissue during release, greatly reducing interference and impact on important intracranial neurovascular structures during surgery. After the occluder 100 extends out of the sheath 310, it can quickly return to its original shape when it was fixed, which can effectively seal the opening of the sphenoid sinus 200, providing a guarantee for postoperative recovery of the sphenoid sinus 200 approach surgery. The device has a simple structure, low cost, and is easy to promote in clinical practice.

[0115] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A sealing device, characterized in that, The occluder is used to occlude the intracranial sphenoid sinus. The occluder has a constriction configuration for delivery and a predetermined expansion configuration. The occluder includes: The distal anchoring structure includes an elastic anchor for anchoring to the distal side of the floor wall of the sphenoid sinus. A proximal occlusion disc is disposed on the proximal side of the floor wall of the sphenoid sinus and is used to seal the opening on the floor wall of the sphenoid sinus. The connecting part has a distal end connected to the distal anchoring structure and a proximal end connected to the proximal occlusion disc. The connecting part has an outer diameter suitable for the size of an opening on the bottom wall of the sphenoid sinus. In the contraction configuration, the outer side of the elastic anchor is further away from the proximal sealing disc than the central region. The distal anchoring structure, the proximal sealing disc, and the connecting part are woven into a single structure by braided wires, wherein the braided ends of the braided wires are gathered at the proximal end of the proximal sealing disc. The distal anchoring structure, the proximal sealing plate, and the connecting part are all double-layer woven mesh structures made of the braided wires. The elastic anchor is a ring-shaped structure, and the cross-section of the ring-shaped structure is a double-layer woven mesh. The connection portion is formed by the double-layer woven mesh structure between the distal anchoring structure and the proximal sealing plate. The connecting part has a first cavity, the distal end of the first cavity is connected to the inner ring of the elastic anchor, the proximal end of the first cavity is connected to the interior of the proximal sealing disk, the proximal sealing disk is provided with a first sealing membrane, and the first sealing membrane is connected to the proximal sealing disk through a suture. The proximal end of the proximal sealing disc is provided with a conveying ring. The braided filaments at the gathering opening of the braided mesh constituting the proximal sealing disc are folded back to form the conveying ring; The occluder is conveyed by the conveying ring, which is pre-shaped into a ring structure through heat treatment. During conveying, a conveying wire passes through the conveying ring and works with the conveying rod to push the occluder out of the sheath. To release, first untie one end of the conveying wire and then pull it out from the other end to complete the release. After the release is completed, the conveying ring springs back and adheres to the proximal occluder disc due to the shaping effect.

2. A sealing device, characterized in that, The occluder is used to occlude the intracranial sphenoid sinus. The occluder has a constriction configuration for delivery and a predetermined expansion configuration. The occluder includes: The distal anchoring structure includes an elastic anchor for anchoring to the distal side of the floor wall of the sphenoid sinus. A proximal occlusion disc is disposed on the proximal side of the floor wall of the sphenoid sinus and is used to seal the opening on the floor wall of the sphenoid sinus. The connecting part has a distal end connected to the distal anchoring structure and a proximal end connected to the proximal occlusion disc. The connecting part has an outer diameter suitable for the size of an opening on the bottom wall of the sphenoid sinus. In the contraction configuration, the outer side of the elastic anchor is further away from the proximal sealing disc than the central region. The distal anchoring structure includes a plurality of elastic anchors arranged at intervals along the circumference. The proximal ends of the plurality of elastic anchors are fixedly connected to the connecting portion, and the distal ends of the plurality of elastic anchors are anchored to one side of the distal end of the floor wall of the sphenoid sinus. The distal end of the elastic anchor is also provided with a first anchoring end, which contacts the floor wall of the sphenoid sinus. The metal skeleton of the occluder consists of two parts: a mesh structure woven from elastic metal wires and a laser-cut and shaped metal skeleton. It is pre-shaped into a two-disc, one-waist structure through heat treatment. The two discs include an upper disc surface and a lower disc surface. The upper disc surface is formed by laser cutting of metal, and the lower disc surface is formed by woven metal mesh. The upper disc surface is the distal anchoring structure, and the lower disc surface is the proximal occlusion disc. The distal anchoring structure is formed by laser cutting of metal and shaped into an outward-folding, inverted shape; The proximal end of the proximal sealing disc is provided with a conveying ring. The braided filaments at the gathering opening of the braided mesh constituting the proximal sealing disc are folded back to form the conveying ring; The occluder is conveyed by the conveying ring, which is pre-shaped into a ring structure through heat treatment. During conveying, a conveying wire passes through the conveying ring and works with the conveying rod to push the occluder out of the sheath. To release, first untie one end of the conveying wire and then pull it out from the other end to complete the release. After the release is completed, the conveying ring springs back and adheres to the proximal occluder disc due to the shaping effect.

3. The occluder according to claim 1 or 2, characterized in that, The first occlusion membrane has an outer diameter that matches the surface of the proximal occlusion disc, and a portion of the proximal occlusion disc is attached to the proximal side of the floor wall of the sphenoid sinus.

4. The occluder according to claim 3, characterized in that, The connecting part is provided with a second sealing membrane, which is used to seal the opening of the sphenoid sinus.

5. The plugging device according to claim 3, characterized in that, The proximal occlusion disc is woven from metal braided wires. The proximal occlusion disc is connected to the first occlusion membrane by sutures, and the connecting part is connected to the second occlusion membrane by sutures.

6. The occluder according to claim 5, characterized in that, The proximal occlusion disc is provided with an implantable adhesive, which is used to seal the gap between the proximal occlusion disc and the floor wall of the sphenoid sinus, as well as the gap between the first occlusion membrane and the floor wall of the sphenoid sinus; And / or, the connecting portion is provided with an implantable adhesive, the adhesive being used to seal the gap between the connecting portion and the opening of the sphenoid sinus and the gap between the second occlusion membrane and the opening of the sphenoid sinus.

7. The plugging device according to claim 1, characterized in that, The conveying ring is also used to grab the plug and retrieve the plug.

8. A sealing system, characterized in that, The blocking system includes: The plugging device as described in any one of claims 1-7; The sheath, wherein the occluder is disposed within the sheath, wherein the distal anchoring structure and the proximal occluder disc are converging within the sheath; A delivery wire, which is detachably connected to the proximal end of the proximal end sealing disc; A conveyor rod, to which the conveyor wire is connected, is used to convey the plugging device.

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