Temporary paranasal sinus opening instrument

Abstract

The invention provides a temporary paranasal sinus opening instrument, and belongs to the technical field of medical instruments. Comprising a conveying catheter and a supporting stent, the supporting stent comprises a tubular supporting part and a recycling part located at one end of the supporting part, the supporting part comprises a tubular framework and a hemostasis component arranged on the outer side of the tubular framework in a covering mode, and the tubular framework is an alloy stent with a shape memory function; the recovery part comprises a channel opening formed in one end of the tubular framework and a connecting rod, the channel opening is a beveled opening with the opening face forming an acute angle with the axis of the supporting part, the connecting rod is connected with the end, farthest from the other end of the tubular framework, of the channel opening, and the supporting part has the contraction state that the supporting part is folded and stored in the conveying catheter. The stretching state extends out of the conveying catheter and is released to be opened. The technical problem that in an existing paranasal sinus operation, the operation efficiency is low due to instrument defects can be solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a temporary sinus opening device. Background Technology

[0002] Sinus surgery is a medical procedure designed to remove diseased tissue from the sinuses and restore normal ventilation and drainage. Current sinus surgeries primarily include functional endoscopic sinus surgery (FESS) and sinus balloon dilation (BSS).

[0003] Functional endoscopic sinus surgery utilizes a variety of cutting, clamping, and milling instruments, tailored to the patient's anatomy and pathological response. In the most challenging cases, surgeons operating within the sinus structures can employ neuro-navigation systems, displaying the instrument's position in real-time on a monitor to clearly identify the lesion while avoiding damage to vital structures such as the skull base and orbit. Sinus balloon dilation involves using a small balloon to enlarge the sinus ostia and clear any obstructions. Once positioned correctly, the balloon is inflated to open and drain the blocked sinus passages. After the passages are open, the balloon is deflated and removed.

[0004] Current sinus surgeries rely on a variety of instruments for complex procedures, often requiring balloon dilation of the narrowed area or the use of endoscopes and septal dissectors to separate tissues. The confined space and complex structure of the sinus ostia and other narrow areas make the entry and manipulation of surgical instruments (such as dilation balloons and dissectors) particularly difficult, increasing the complexity and risk of the initial surgical phase. When addressing stenosis or bleeding, the surgery must be paused for hemostasis (such as gauze packing), and the removal of diseased tissue can only continue after the bleeding is completely controlled. Key obstruction points (such as opening the narrowed area) must be addressed first and hemostasis achieved before subsequent lesion removal can proceed. This step-by-step surgical approach significantly prolongs the operation time, interrupting continuous treatment of the target lesion during hemostasis and impacting surgical efficiency. Summary of the Invention

[0005] This invention provides a temporary sinus opening device that solves the technical problem of low surgical efficiency caused by instrument defects in existing sinus surgeries. The technical solution is as follows: This invention provides a temporary sinus opening device, comprising: Delivery conduits and support structures, The support frame includes a tubular support portion and a retrieval portion located at one end of the support portion. The support portion includes a tubular skeleton and a hemostatic component covering the outside of the tubular skeleton. The tubular skeleton is an alloy support with shape memory function. The retrieval portion includes a channel opening located at one end of the tubular skeleton and a connecting rod. The channel opening is a beveled opening. The connecting rod is connected to the proximal end of the channel opening. The support portion has a contracted state where it is folded and housed within the delivery catheter, and an extended state where it extends out of the delivery catheter and is released and opened.

[0006] Optionally, the tubular skeleton is a filament-woven structure or a tubular laser-cut and shaped structure.

[0007] Optionally, the hemostatic component includes a coating, a hemostatic drug coating, or a hemostatic gel.

[0008] Optionally, when the hemostatic component is the covering, the covering is fixed to the outside of the tubular skeleton by suture stitching or heat fusion.

[0009] Optionally, when the hemostatic component is the hemostatic drug coating, the hemostatic drug coating is attached to the outer surface of the tubular skeleton by spraying or dipping.

[0010] Optionally, the other end of the tubular skeleton is provided with a flared structure, the diameter of which gradually decreases from the distal end to the proximal end.

[0011] Optionally, the flared structure is annular or consists of protruding teeth spaced apart around the other end of the tubular skeleton.

[0012] Optionally, it also includes a mucosal removal device, which includes a connecting rod and a spoon-shaped end disposed at one end of the connecting rod, wherein the angle between the spoon-shaped end and the connecting rod is adjustable in an environment of less than or equal to 40°C.

[0013] Optionally, the tubular framework is a nickel-titanium alloy scaffold.

[0014] Optionally, a gripping protrusion is provided on the outer wall of one end of the delivery conduit.

[0015] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following: Breaking away from the traditional step-by-step "dilation-hemostasis-lesion removal" operation mode of sinus surgery, this procedure achieves simultaneous opening of the sinus cavity and hemostasis. With the aid of the delivery catheter, the support stent completes both sinus ostium dilation and wound compression hemostasis in a single release action. The surgery does not require interruption to wait for hemostasis to complete, significantly shortening the operation time and reducing the time and associated risks for the patient under anesthesia.

[0016] It provides a stable support channel and a clear surgical field for the operation. The continuous radial support force generated by the shape memory alloy skeleton can keep the sinus ostium open and prevent collapse, while the hemostatic components continuously control wound bleeding, avoiding blood accumulation that obscures the field of vision. This allows the surgeon to operate precisely under good visualization conditions, reducing accidental damage to surrounding normal tissues and improving surgical safety and the thoroughness of lesion removal.

[0017] The device employs a temporary instrument design, allowing for immediate retrieval and withdrawal post-procedure, thus avoiding the risks of complications such as foreign body reaction, secondary infection, and mucosal irritation that can occur with indwelling devices. The obliquely shaped opening ensures a smooth retrieval process, preventing jamming or the need for secondary procedures, reducing patient discomfort and the burden on healthcare providers.

[0018] It solves the problem of difficult instrument passage in narrow sinus openings. In the constricted state, the instrument diameter is small and easy to deliver; in the extended state, it provides ample operating space. The reversible conversion between the two states perfectly balances the contradiction between delivery performance and support performance. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the structure of the temporary sinus opening device provided in this embodiment of the invention, in which the support part is folded and stored inside the delivery catheter; Figure 2 This is a schematic diagram of the structure of the temporary sinus opening device provided in the embodiment of the present invention with the support part in an extended state; Figure 3 This is a schematic diagram of the tubular skeleton provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of a tubular skeleton structure provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of another tubular skeleton form provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of the tubular skeleton with a flared structure provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of the mucosal removal device and the support bracket provided in the embodiment of the present invention; Figure 8 This is a schematic diagram of the patient's nasal cavity state during a sinus surgery according to an embodiment of the present invention; Figure 9This is a schematic diagram of the temporary sinus opening device of this invention being inserted into the opening of the maxillary sinus. Figure 10 This is a schematic diagram of the state during sinus surgery to remove diseased tissue according to an embodiment of the present invention; Figure 11 This is a schematic diagram of the postoperative nasal cavity state of a patient during a sinus surgery according to an embodiment of the present invention; Figure 12 This is a schematic diagram of the patient's nasal cavity state during a sinus surgery according to an embodiment of the present invention; Figure 13 This is a schematic diagram of the temporary sinus opening device inserted into the nasal cavity in an embodiment of the present invention; Figure 14 This is a schematic diagram of the state during the removal of diseased tissue in another sinus surgery according to an embodiment of the present invention; Figure 15 This is a schematic diagram of the postoperative nasal cavity state of a patient during another sinus surgery according to an embodiment of the present invention.

[0021] In the diagram: 1-Delivery catheter; 2-Supporting stent; 3-Mucosal removal device; 11-Holding protrusion; 21-Supporting part; 22-Retrieval part; 31-Connecting rod; 32-Spoon-shaped end; 211-Tubular skeleton; 212-Hemostatic component; 213-Expanding structure; 221-Channel opening; 222-Connecting rod; 2131-Extending tooth; m-Maxillary sinus; n-Maxillary sinus opening; o-Disease tissue; p-Nasal passage. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

[0023] Figure 1 This is a schematic diagram of the structure of the temporary sinus opening device provided in this embodiment of the invention, in which the support part is folded and stored inside the delivery catheter; Figure 2 This is a schematic diagram of the structure of the temporary sinus opening device provided in the embodiment of the present invention with the support part in an extended state; Figure 3 This is a schematic diagram of the tubular skeleton provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of a tubular skeleton structure provided in an embodiment of the present invention; Figure 5 This is a schematic diagram of another tubular skeleton form provided in an embodiment of the present invention; Figure 6 This is a schematic diagram of the tubular skeleton with a flared structure provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of the mucosal removal device and the support bracket provided in the embodiment of the present invention; Figure 8 This is a schematic diagram of the patient's nasal cavity state during a sinus surgery according to an embodiment of the present invention; Figure 9This is a schematic diagram of the temporary sinus opening device of this invention being inserted into the opening of the maxillary sinus. Figure 10 This is a schematic diagram of the state during sinus surgery to remove diseased tissue according to an embodiment of the present invention; Figure 11 This is a schematic diagram of the postoperative nasal cavity state of a patient during a sinus surgery according to an embodiment of the present invention; Figure 12 This is a schematic diagram of the patient's nasal cavity state during a sinus surgery according to an embodiment of the present invention; Figure 13 This is a schematic diagram of the temporary sinus opening device inserted into the nasal cavity in an embodiment of the present invention; Figure 14 This is a schematic diagram of the state during the removal of diseased tissue in another sinus surgery according to an embodiment of the present invention; Figure 15 This is a schematic diagram illustrating the postoperative nasal cavity state of a patient during another sinus surgery according to an embodiment of the present invention. Figures 1 to 15 As shown, an embodiment of the present invention provides a temporary sinus opening device, including: a delivery catheter 1 and a support bracket 2.

[0024] The support bracket 2 includes a tubular support portion 21 and a retrieval portion 22 located at one end of the support portion 21. The support portion 21 includes a tubular skeleton 211 and a hemostatic component 212 covering the outside of the tubular skeleton 211. The tubular skeleton 211 is an alloy bracket with shape memory function. The retrieval portion 22 includes a channel opening 221 located at one end of the tubular skeleton 211 and a connecting rod 222. The channel opening 221 is a beveled opening. The connecting rod 222 is connected to the proximal end of the channel opening 221. The support portion 21 has a contracted state that is folded and stored inside the delivery catheter 1, and an extended state that extends out of the delivery catheter 1 and is released and opened.

[0025] In this embodiment of the invention, the temporary sinus opening device consists of a delivery catheter 1 and a support frame 2 that cooperate with each other. The tubular skeleton 211, which forms the main body of the support part 21, is made of a nickel-titanium alloy material with shape memory function. This material has superelastic properties and can undergo large deformation under external force without permanent plastic deformation. When the external force is removed, it can automatically return to the preset shape. The retrieval part 22 at one end of the tubular skeleton 211 includes a channel opening 221 and a connecting rod 222. The channel opening 221 is designed with a beveled opening. This beveled structure allows the tubular skeleton 211 to smoothly enter the delivery catheter 1 during surgical retrieval without obstruction, avoiding edge snagging problems that may be caused by vertical incisions. The connecting rod 222 is connected to the end of the channel opening 221 that is farthest from the other end of the tubular skeleton 211. By pushing the connecting rod 222, the support frame 2, which is folded and stored in the delivery catheter 1, can be pushed out. By pulling the connecting rod 222, the entire support frame 2 can be retrieved into the delivery catheter 1. It should be noted that the proximal end mentioned in the embodiments of the present invention refers to the end of the temporary sinus opening device that is closest to the operator during operation.

[0026] The support 21 has a retracted state where it is folded and stored inside the delivery catheter 1, and an extended state where it extends out of the delivery catheter 1 and is released and opened. In the retracted state, the tubular skeleton 211 is radially compressed and bound within the inner cavity of the delivery catheter 1. At this time, the overall diameter of the support 2 is smaller than the inner diameter of the delivery catheter 1, which facilitates delivery to the target location through the narrow nasal passage.

[0027] refer to Figures 8 to 11During the preoperative preparation phase, the nasal cavity and maxillary sinus structure are observed under endoscopic guidance to determine the location of the narrowed maxillary sinus opening. Since the maxillary sinus opening is typically only 2-8 mm in diameter and surrounded by complex anatomical structures, including the orbital wall and skull base, precise positioning is crucial. During instrument insertion, the retracted support stent 2 is loaded into the delivery catheter 1, with an overall outer diameter controlled to 4-6 mm, allowing for smooth passage through the narrow nasal passages. Under direct endoscopic visualization, the distal end of the delivery catheter 1 is pushed to the narrowed maxillary sinus opening, avoiding blind manipulation that could cause mucosal damage or accidental entry into other cavities. During stent release and cavity opening, once the delivery catheter 1 is in place, the surgeon either retracts the delivery catheter 1 backwards or pushes the connecting rod 222 forwards to release the support stent 2 from the constraint of the delivery catheter 1. At this time, the tubular skeleton 211 with shape memory function immediately changes from a contracted state to an extended state, radially expanding to a preset diameter (usually 10-15 mm), applying a uniform radial support force to the narrow maxillary sinus opening n, opening the originally narrow and blocked cavity to a sufficient surgical operating space. As the support scaffold 2 expands, the hemostatic component 212 covering the outside of the tubular skeleton 211 unfolds and closely adheres to the mucosal surface around the maxillary sinus opening n. The hemostatic component 212 achieves hemostasis through the following mechanisms: (1) Mechanical compression hemostasis: Under the radial support force generated by the expansion of the scaffold, the hemostatic component 212 applies a continuous and uniform pressure force to the mucosal wound, causing the small blood vessels in the wound to be compressed and closed, reducing bleeding; (2) Hemostatic material effect: If the hemostatic component 212 uses a film or hemostatic gel containing hemostatic drugs, the drug components can promote platelet aggregation and accelerate the activation of coagulation factors, further enhancing the hemostatic effect. The key advantage of this simultaneous hemostasis mechanism is that the opening of the cavity and the removal and hemostasis of lesions such as nasal mucosa or polyps are completed simultaneously, without interrupting the surgical procedure for dedicated hemostasis, thus avoiding the time delays of traditional procedures that require hemostasis before continuing the surgery. With the support stent 2 maintaining cavity patency and continuous hemostasis, the surgeon can insert other surgical instruments into the dilated maxillary sinus cavity through the channel opening 221 inside the support stent 2. Because the cavity is stably supported and the field of vision is clear (without active bleeding interference), the surgeon can accurately locate the lesion mucosa and thoroughly remove polypoid changes, proliferative inflammatory mucosa, and other lesions using curettes, forceps, and other instruments. Throughout the lesion removal process, the support stent 2 maintains cavity patency, and wound bleeding is continuously controlled, ensuring the continuity and safety of the surgical procedure. After the lesion tissue is removed, the surgeon moves the delivery catheter 1 back to a position near the maxillary sinus opening n in the patient's nasal cavity, grasps the connecting rod 222, and applies external pulling force. Since the connecting rod 222 is fixedly connected to the farthest end of the channel opening 221, the pulling force is first transmitted to this position, causing the recovery part 22 to move towards the delivery conduit 1.The oblique design of the channel opening 221 allows it to smoothly enter the opening of the delivery catheter 1 without being obstructed. With continuous pulling, the entire support 21 radially contracts under the pulling force, gradually folding back into the delivery catheter 1. Finally, the support bracket 2 is completely retracted into the delivery catheter 1 and withdrawn from the body along with the delivery catheter 1. The entire retrieval process is smooth and rapid, usually completed within 5-10 seconds, avoiding complications such as foreign body reaction and infection risk that may arise from indwelling devices.

[0028] The temporary sinus opening device provided in this invention breaks through the traditional sinus surgery operation mode of "dilation-hemostasis-lesion removal" in steps, achieving simultaneous completion of cavity opening and hemostasis. In conjunction with the delivery catheter 1, the support stent 2 completes both sinus ostium dilation and wound compression hemostasis in a single release action. The surgery does not need to be interrupted to wait for hemostasis to complete, significantly shortening the operation time by approximately 20-30%, reducing the time and related risks for the patient under anesthesia, and providing a stable support channel and clear surgical field. The continuous radial support force generated by the shape memory alloy skeleton maintains the sinus ostium in an open state without collapse, while the hemostatic components continuously control wound bleeding, preventing blood accumulation from obscuring the field of vision. This allows the surgeon to operate precisely under good visualization conditions, reducing accidental damage to surrounding normal tissues and improving surgical safety and the thoroughness of lesion removal. The temporary device design allows for immediate retrieval and withdrawal after surgery, avoiding the risks of complications such as foreign body reaction, secondary infection, and mucosal irritation that may arise from indwelling devices. The oblique-cut opening design of the 221 channel ensures a smooth retrieval process, preventing jamming or the need for secondary operations, thus reducing patient discomfort and medical burden. It solves the problem of difficult instrument passage at narrow sinus openings; in the constricted state, the instrument diameter is small, making delivery easy; in the extended state, it provides ample operating space. This reversible transition between the two states perfectly balances the conflict between delivery and support performance.

[0029] Exemplarily, in an embodiment of the present invention, reference is made to... Figures 12 to 15 In another surgical procedure, where the wall of the maxillary sinus opening n in the patient's nasal cavity is unobstructed and there is no damage or bleeding, after the surgical instruments are delivered into the patient's maxillary sinus m cavity, the support stent 2 is delivered along with the delivery catheter 1 into the nasal passage p located above the maxillary sinus opening n in the patient's nasal cavity for opening and stretching. This allows for the removal of lesions in the maxillary sinus m while simultaneously stopping any bleeding wounds that may exist in the nasal passage p (caused by the removal of lesions such as mucosa or polyps in the nasal passage p), thus achieving another "expansion-hemostasis-lesion removal" operation mode.

[0030] Optionally, the tubular skeleton 211 is a filament-woven structure or a tubular laser-cut and shaped structure. Exemplarily, in an embodiment of the present invention, reference is made to... Figure 4The tubular skeleton 211 employs a filament-woven structure. The specific manufacturing process involves selecting several nickel-titanium alloy filaments with a diameter of 0.05-0.15 mm and cross-weaving them at a predetermined angle on a specialized braiding machine to form a mesh-like tube. After weaving, the tube is placed on a shaping mold and heat-treated at 450-550℃ for 1-2 hours to achieve a pre-defined shape memory in its extended state. The advantages of the filament-woven structure include good flexibility; it can be compressed to a very small diameter (typically 20-30% of the original diameter) in a contracted state, facilitating passage through narrower channels; the cross-woven structure provides good radial support uniformity during extension, ensuring balanced force distribution in all directions and minimizing localized stress concentration; and the mesh structure offers good openness, facilitating full contact between hemostatic components and the mucosal surface, and also allowing for observation of the internal condition and the passage of other instruments.

[0031] Alternatively, a tubular laser-cut structure can be used for shaping. (Reference) Figure 5 The specific manufacturing process is as follows: a thin-walled nickel-titanium alloy tube with a wall thickness of 0.1-0.3mm is selected, and a laser cutting device is used to precisely cut it according to a pre-designed grid pattern (such as a diamond grid, a hexagonal grid, etc.) to form a tubular support with a specific mesh structure. After cutting, heat treatment is also required to fix its shape memory in its extended state.

[0032] The advantages of tubular laser-cut shaped structures are high processing precision, enabling complex grid pattern designs and precise control of mesh size, shape, and distribution to meet different surgical needs; good consistency in scaffold wall thickness and strong predictability of mechanical properties; superior surface smoothness compared to woven structures, reducing mechanical irritation to the mucosa; and better quality stability and high product consistency during mass production.

[0033] Regardless of the manufacturing process used, the tubular skeleton 211 can be guaranteed to have good shape memory function and super elasticity, meeting the needs of reversible conversion between contraction and extension states in clinical use, and providing reliable cavity support for surgery.

[0034] Optionally, the hemostatic component 212 includes a coating, a hemostatic drug coating, or a hemostatic gel. Exemplarily, in embodiments of the present invention, the hemostatic component 212 can take many specific forms.

[0035] Option 1: The hemostatic component 212 is a membrane. This membrane is made of a biocompatible polymer material, such as medical polyurethane film, silicone rubber film, or biodegradable polylactic-glycolic acid copolymer (PLGA) film, with a thickness typically of 0.01-0.05 mm. The membrane has a certain degree of elasticity and flexibility, and can unfold with the radial expansion of the tubular skeleton 211, forming a continuous covering surface in the extended state, closely adhering to the mucosal wound surface.

[0036] The draping method primarily achieves hemostasis through mechanical compression. When the stent expands, the drape applies uniform and continuous pressure (typically 5-15 mmHg) to the mucosal wound under radial support, causing the capillaries and venules in the wound to close under pressure, reducing blood flow velocity, and promoting platelet adhesion and aggregation, as well as the activation of coagulation factors, leading to the formation of a stable thrombus to seal the bleeding point. The advantages of this purely physical compression hemostasis method are: it does not rely on drug action, avoiding potential allergic reactions or side effects caused by drugs; the hemostatic effect is highly predictable, as reliable hemostasis is achieved as long as the pressure is appropriate; the drape also acts as a physical barrier to prevent blood leakage into the cavity, maintaining a clear field of vision.

[0037] Furthermore, when the hemostatic component 212 is a covered membrane, the membrane is fixed to the outside of the tubular skeleton 211 by suture or heat fusion. In clinical applications, the appropriate fixation method can be selected based on manufacturing process conditions and cost considerations. For small-batch customized production or situations requiring special covered membrane materials, suture fixation is more flexible and convenient; for large-batch standardized production, heat fusion fixation is more efficient and less costly. Regardless of the fixation method used, the key is to ensure that the membrane can fully expand with the stent and adhere tightly to the mucosal surface during stent expansion to achieve effective hemostasis, and that it can be smoothly folded back into the delivery catheter along with the stent during stent retrieval without membrane detachment or residue.

[0038] Form Two: Hemostatic component 212 is coated with a hemostatic drug. A coating containing a hemostatic drug is applied to the outer surface of the tubular skeleton 211 using an impregnation or spraying process. The hemostatic drug can be a procoagulant or vasoconstrictor such as thrombin, tranexamic acid, or adrenaline, or a biomaterial with hemostatic properties such as chitosan or collagen. The coating thickness is typically 5-50 micrometers, and the drug content is controlled at 0.1-5 mg / cm³. 2 .

[0039] The hemostatic drug coating combines the dual effects of mechanical compression and pharmacological hemostasis. The pressure provided by stent expansion is the basic hemostatic mechanism, while the hemostatic drugs in the coating, once dissolved, act rapidly on the wound: thrombin directly catalyzes the conversion of fibrinogen to fibrin, accelerating the coagulation reaction; tranexamic acid stabilizes existing blood clots by inhibiting plasminogen activation; and adrenaline constricts small blood vessels in the wound, reducing blood flow. This combined hemostatic mechanism is rapid in onset (typically significantly reducing bleeding within 1-3 minutes) and provides thorough hemostasis, making it particularly suitable for large wounds or cases with diffuse oozing.

[0040] Furthermore, when the hemostatic component 212 is coated with a hemostatic drug, the hemostatic drug coating is attached to the outer surface of the tubular skeleton 211 by spraying or dipping. The advantages of the spraying process are that the coating thickness can be precisely controlled. By adjusting the concentration of the spraying solution, the number of sprays, and the spraying speed, precise control within the range of 5-50 micrometers can be achieved to meet the needs of different drug dosages; the drug utilization rate is high, as the drug solution is directly deposited on the stent surface during the spraying process, with less waste, and it has a cost advantage for expensive drugs (such as thrombin, growth factors, etc.); it is suitable for localized point coating, and different drugs or different thicknesses can be coated in different areas of the stent to achieve functional zoning design; the drying speed is fast, and the solvent consumption is small, which is conducive to the preservation of drug activity, and it is particularly suitable for coating protein drugs (such as thrombin). The advantages of the impregnation process are: good coating coverage, allowing the drug solution to fully penetrate all surfaces and the inner side of the mesh of the stent, forming a fully covered drug coating with no dead corners; simple operation, low equipment investment, suitable for small-batch production or laboratory research; the coating adheres tightly to the stent surface, especially when supplemented with ultrasonic vibration, drug molecules can penetrate into the tiny pores of the stent surface, enhancing adhesion and making it less likely to fall off during device use; multiple impregnations can achieve layered design of the coating, such as loading the inner layer with procoagulant drugs and the outer layer with antibacterial drugs, constructing a multifunctional composite coating.

[0041] Whether prepared by spraying or impregnation, the drug coating can make full contact with the mucosal wound during stent expansion, achieving effective drug release and hemostasis.

[0042] Form 3: The hemostatic component 212 is a hemostatic gel. A layer of hemostatic gel material, such as gelatin sponge gel, fibrin gel, or chitosan gel, is pre-coated on the outer surface of the tubular skeleton 211. The gel material has water-absorbing and swelling properties; upon contact with blood, it rapidly absorbs water and swells, filling the wound gaps and physically sealing the bleeding points. At the same time, the gel matrix provides a procoagulant microenvironment, accelerating the coagulation process.

[0043] The unique advantages of hemostatic gels lie in their physical sealing effect and the creation of a procoagulant microenvironment. After absorbing water and swelling, the gel forms a semi-solid covering layer that can fill depressions in irregular wound surfaces, achieving a more comprehensive sealing effect, especially suitable for uneven mucosal surfaces. Simultaneously, the gel matrix can adsorb and concentrate clotting factors and platelets in the blood, creating a high-concentration procoagulant environment locally, significantly accelerating the coagulation process. Furthermore, gel materials such as gelatin and collagen themselves promote tissue healing and have a positive impact on postoperative wound repair.

[0044] In clinical use, the appropriate form of hemostatic component can be selected based on the patient's specific condition: for patients with normal coagulation function and regular wound surfaces, a film covering is sufficient; for patients with poor coagulation function or significant wound bleeding, it is recommended to use a hemostatic drug coating or hemostatic gel to achieve a faster and more reliable hemostatic effect. The variety of designs provides flexibility for clinical application, meeting the personalized needs of different patients and surgical procedures.

[0045] Optionally, the other end of the tubular skeleton 211 is provided with a flared structure 213, such as... Figure 6 As shown, the diameter of the flared structure 213 gradually decreases from the distal end to the proximal end. Exemplarily, in this embodiment of the invention, the flared structure 213 is designed with the following features: its diameter gradually decreases from the distal end to the proximal end, forming a funnel or flared shape. The proximal end of the flared structure 213 is closer to the operator, i.e., the end connected to the tubular skeleton 211, while the distal end is the other end of the flared structure 213 in the axial direction. The flared structure 213 and the main tubular portion of the tubular skeleton 211 are integrally formed, both made of nickel-titanium alloy with shape memory function. This structure better adapts to the physiological morphology of the sinuses. The anatomical characteristics of human sinuses (especially the maxillary and frontal sinuses) are that the sinus cavity is much larger than the sinus opening, presenting a "small opening, large cavity" structure. The sinus opening is usually only 5-8 mm in diameter, while the sinus cavity diameter can reach 20-30 mm or even larger. The flared shape of the flared structure 213 perfectly matches this anatomical feature: the flared portion at the front end of the stent can extend into a wider area of ​​the sinus cavity and fully expand, while the larger diameter of the flared portion applies gentle support to the inner wall of the sinus cavity, stabilizing the stent's position and preventing displacement or dislodgement; simultaneously, the flared structure gradually narrows proximally, smoothly transitioning to a tubular main body portion that matches the diameter of the sinus ostium, which effectively expands the narrow sinus ostium area. This morphological matching design allows the stent to achieve good fit and support in both the sinus cavity and the sinus ostium, two anatomically different sized areas. The flared structure 213 is also covered with a hemostatic component 212 (such as a membrane or coating), whose larger surface area can cover a wider mucosal area at the sinus cavity entrance. Since bleeding during sinus surgery originates not only from incision or dilation at the narrow sinus ostium but also from damage to the superficial mucosa of the sinus cavity (such as abrasions during exploration or cleaning), the additional hemostatic area provided by the flared structure effectively controls bleeding in these areas, further improving the surgical field and reducing intraoperative blood loss.

[0046] Optionally, refer to Figure 10The flaring structure 213 is annular or consists of protruding teeth 2131 spaced around the other end of the tubular skeleton 211. Exemplarily, in this embodiment of the invention, the annular flaring structure 213 has the advantage of continuous and uniform distribution of support force. The radial support force exerted by the annular structure on the inner wall of the sinus cavity is evenly distributed throughout the circumference, without local stress concentration, avoiding point-like pressure damage to the mucosa and providing good comfort. The protruding teeth 2131 structure has the advantage of better radial compressibility. The open gaps between the protruding teeth 2131 allow for greater inward folding in the contracted state, further reducing the contracted diameter of the support stent 2, which is beneficial for passing through extremely narrow nasal passages. Furthermore, the open gaps between the protruding teeth 2131 provide multiple observation windows for the endoscope, allowing the surgeon to observe the deep sinus cavity from different angles, compensating for any visual obstruction that may occur at the opening of the support stent 2.

[0047] Optionally, the device further includes a mucosal removal device 3, which includes a connecting rod 31 and a spoon-shaped end 32 disposed at one end of the connecting rod 31. The angle between the spoon-shaped end 32 and the connecting rod 31 is adjustable in an environment of less than or equal to 40°C. Exemplarily, in this embodiment of the invention, the mucosal removal device 3 is made of medical-grade stainless steel or nickel-titanium alloy, possessing a certain degree of flexibility but not easily deformed permanently. The spoon-shaped end 32 is shaped like a miniature spoon or shovel, with a blade width of 3-8 mm and a depth of 2-5 mm. The edge is sharp but not overly sharp (to avoid cutting normal tissue), and is used to extend into the sinus cavity under the drive of the connecting rod 31 to scrape or remove diseased mucosa.

[0048] The spoon-shaped end 32 and the connecting rod 31 are angle-adjustable in environments with temperatures less than or equal to 40°C. This feature is achieved based on a special material design. The connecting rod 31 and the spoon-shaped end 32 are made of a nickel-titanium alloy material that has undergone a special heat treatment process. The austenite transformation completion temperature (Af point) of this material is set to be higher than human body temperature (37°C) but not exceeding 45°C, and is typically controlled within the range of 40-43°C. This material design allows it to remain in the martensitic phase at room temperature (typically 20-25℃) or body temperature (37℃), i.e., less than or equal to 40℃. It exhibits excellent superelasticity and plasticity, allowing the surgeon to easily adjust the angle between the spoon-shaped end 32 and the connecting rod 31 by hand or with simple tools to adapt to the needs of different lesion locations. When it is necessary to restore the initial angle (e.g., when the lesion location changes during surgery and the angle needs to be readjusted), the instrument can be placed in an environment exceeding 40℃ (e.g., warm water, oven, etc.) for heating. The material phase transforms into the austenitic phase, and it automatically returns to the pre-set initial angle (usually a straight line or slightly bent state with a 0-30 degree angle between the spoon-shaped end and the connecting rod) due to the shape memory effect.

[0049] Optionally, a gripping protrusion 11 is provided on the outer wall of one end of the delivery catheter 1. Exemplarily, in this embodiment of the invention, the operating space for sinus surgery is confined, and the surgeon needs to precisely control the pushing and retracting movements of the instrument, requiring control precision at the millimeter or even sub-millimeter level. The smooth surface of the delivery catheter 1 can easily become slippery in the surgical environment (which may be contaminated with blood, mucus, or saline), causing the surgeon to slip and affecting operational precision, potentially leading to accidental instrument dislodgement. The gripping protrusion 11 provides clear gripping markings and increased friction, allowing the surgeon to firmly press their fingers on the protrusion, maintaining a stable grip even in a wet environment and preventing slippage. This stable grip enables the surgeon to more precisely control the pushing depth and retraction speed of the delivery catheter 1, reducing operational errors caused by unstable grip.

[0050] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by one of ordinary skill in the art described herein. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Similarly, the terms “an” or “a” and similar terms do not indicate a quantity limitation, but rather indicate the presence of at least one. The terms “comprising” or “including” and similar terms mean that the elements or objects preceding “comprising” or “including” encompass the elements or objects listed following “comprising” or “including” and their equivalents, and do not exclude other elements or objects. The terms “connected” or “linked” and similar terms are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. The terms “upper,” “lower,” “left,” “right,” etc., are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0051] The above description is merely an optional embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A temporary sinus opening device, characterized in that, include: Delivery conduit (1) and support bracket (2). The support bracket (2) includes a tubular support portion (21) and a retrieval portion (22) located at one end of the support portion (21). The support portion (21) includes a tubular skeleton (211) and a hemostatic component (212) covering the outside of the tubular skeleton (211). The tubular skeleton (211) is an alloy bracket with shape memory function. The retrieval portion (22) includes a channel opening (221) located at one end of the tubular skeleton (211) and a connecting rod (222). The channel opening (221) is a slanted opening. The connecting rod (222) is connected to the proximal end of the channel opening (221). The support portion (21) has a contracted state that is folded and stored in the delivery catheter (1) and an extended state that extends out of the delivery catheter (1) and is released and opened.

2. The temporary sinus opening device according to claim 1, characterized in that, The tubular skeleton (211) is a filament woven structure or a tubular laser-cut and shaped structure.

3. The temporary sinus opening device according to claim 1, characterized in that, The hemostatic component (212) includes a coating, a hemostatic drug coating, or a hemostatic gel.

4. The temporary sinus opening device according to claim 3, characterized in that, When the hemostatic component (212) is the covering, the covering is fixed to the outside of the tubular skeleton (211) by suture stitching or heat fusion.

5. The temporary sinus opening device according to claim 3, characterized in that, When the hemostatic component (212) is the hemostatic drug coating, the hemostatic drug coating is attached to the outer surface of the tubular skeleton (211) by spraying or impregnation process.

6. The temporary sinus opening device according to any one of claims 1 to 5, characterized in that, The other end of the tubular skeleton (211) is provided with a flared structure (213), the diameter of which gradually decreases from the distal end to the proximal end.

7. The temporary sinus opening device according to claim 6, characterized in that, The flared structure (213) is annular or is an outwardly protruding tooth (2131) arranged at intervals around the other end of the tubular skeleton (211).

8. The temporary sinus opening device according to any one of claims 1 to 5, characterized in that, It also includes a mucosal removal device (3), which includes a connecting rod (31) and a spoon-shaped end (32) disposed at one end of the connecting rod (31). The angle between the spoon-shaped end (32) and the connecting rod (31) is adjustable in an environment of less than or equal to 40°C.

9. The temporary sinus opening device according to any one of claims 1 to 5, characterized in that, The tubular skeleton (211) is a nickel-titanium alloy support.

10. The temporary sinus opening device according to any one of claims 1 to 5, characterized in that, A gripping protrusion (11) is provided on the outer wall of one end of the delivery conduit (1).

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