Nasal septum mucous membrane magnetic suture device and use method thereof

Abstract

The invention belongs to the technical field of suturing devices, and provides a nasal septum mucosa magnetic suturing device and a using method thereof.The nasal septum mucosa magnetic suturing device comprises a first attaching piece and a second attaching piece; magnetic rings are embedded in the inner sides of the first attaching piece and the second attaching piece, and the first attaching piece and the second attaching piece attract each other; convex points are arranged on the inner side surfaces of the first attaching piece and the second attaching piece in an array mode. A drainage hole penetrates through the centers of the first attaching piece and the second attaching piece. Gaps among the convex points are communicated with the drainage holes to form biological seepage channels; the first attaching piece, the second attaching piece, the magnetic ring and the protruding points are arranged, a graft is locked through the micro-anchoring effect of the protruding points, displacement and wrinkles are avoided, suturing-free instant fixing is achieved through automatic adsorption of the magnetic ring, dead space effusion is continuously removed in cooperation with the drainage holes, healing monitoring is allowed, the operation time of a nasal septum repairing operation is greatly shortened, and the operation efficiency is improved. Postoperative newborn tissue effectively seals and perforates, and the respiratory function of a patient is effectively recovered.

Description

Technical Field

[0001] The present invention belongs to the technical field of suturing devices, and in particular to a nasal septum mucosa magnetic suturing device and a method of using the same. Background Art

[0002] In otolaryngology clinical treatment, nasal septum mucosal repair is a core step in surgeries such as nasal septum perforation repair and nasal septum deviation correction. Currently, traditional septum mucosal suturing relies primarily on needle and thread suturing with surgical instruments. Surgeons utilize specialized suturing forceps to navigate the narrow and complex nasal cavity, stitch by stitch, suturing damaged or reattached mucosal tissue.

[0003] According to clinical feedback, even experienced specialists take an average of half an hour to complete a nasal septum suture procedure, while a standard septum suture procedure by an average doctor can take at least an hour. The procedure is extremely tedious and laborious. This suturing method not only greatly tests the surgeon's surgical skills and patience, but also increases the risk of intraoperative and postoperative complications for the patient over a prolonged period.

[0004] Due to the narrow space inside the nasal cavity and limited vision, suturing operations are extremely difficult and can easily cause secondary damage to the mucosa, increasing the risk of infection. On the other hand, traditional suturing methods make it difficult to accurately control the suturing force. If it is too loose, the mucosa will not fit tightly, affecting the repair effect. If it is too tight, it may hinder the blood circulation of the mucosa and cause mucosal necrosis. Problems such as suture residue and thread irritation will also prolong the patient's recovery period.

[0005] As can be seen from the above, the existing method of septum mucosal suturing is cumbersome, time-consuming, requires high technical skills from doctors, and is prone to cause secondary damage to the mucosa and increase the risk of infection.

[0006] To this end, those skilled in the art have proposed a nasal septum mucosa magnetic suturing device and a method of using the same to solve the problems raised in the background art. Summary of the Invention

[0007] In order to solve the above technical problems, the present invention provides a nasal septum mucosa magnetic suturing device and a method of use thereof, so as to solve the problems of the existing nasal septum mucosa suturing method being cumbersome, time-consuming, requiring high technical skills of doctors, and easily causing secondary damage to the mucosa and increasing the risk of infection.

[0008] A nasal septum mucosa magnetic suturing device comprises: a first bonding sheet and a second bonding sheet;

[0009] Magnetic rings are embedded in the inner sides of the first bonding sheet and the second bonding sheet, and the first bonding sheet and the second bonding sheet attract each other; the inner surfaces of the first bonding sheet and the second bonding sheet are arrayed with convex points;

[0010] A drainage hole is provided through the center of the first bonding sheet and the second bonding sheet; the gaps between the protrusions are connected to the drainage hole to form a biological seepage channel.

[0011] Preferably, the first bonding sheet and the second bonding sheet are both provided with guide parts on their circumferential sides.

[0012] Preferably, the height of the bumps is 50-150 μm, the diameter is 100-200 μm, and the distance between adjacent bumps is 200-300 μm.

[0013] Preferably, the first bonding sheet and the second bonding sheet are circular.

[0014] Preferably, the first bonding sheet and the second bonding sheet are oval in shape.

[0015] Preferably, the tissue contact surface pressure generated by the magnetic ring is 15kPa-25kPa.

[0016] A method for using a nasal septum mucosa magnetic suturing device comprises the following steps:

[0017] S1. Cover the nasal septum wound with the graft;

[0018] S2, pressing the convex surface of the first bonding sheet onto the surface of the graft;

[0019] S3. Place a second adhesive patch on the opposite side of the nasal septum, and use suction to fix the graft between the two patches.

[0020] S4, rotating the laminating sheets to adjust the laminating positions of the two sets of laminating sheets;

[0021] S5. Remove the device from each side 7 days after placement.

[0022] Preferably, in S2, a circular bonding sheet is selected to repair a quasi-circular perforation, and an elliptical bonding sheet is selected to repair a narrow and long perforation.

[0023] Preferably, in S4, the drainage holes are observed through an endoscope to confirm that the exudate is discharged through the gaps between the convex points, the guide parts and the drainage holes.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] The present invention provides a first bonding sheet, a second bonding sheet, a magnetic ring and protrusions. The micro-anchoring effect of the protrusions locks the graft to avoid displacement and wrinkling. The automatic adsorption of the magnetic ring achieves instant fixation without suture. The drainage holes continuously clear dead space effusion and allow healing monitoring. This greatly reduces the operation time of nasal septum repair surgery. The new tissue after surgery effectively seals the perforation, and the patient's respiratory function is effectively restored. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1It is a schematic diagram of the overall structure of the present invention;

[0027] Figure 2 This is a plan view of the device placed at the nasal septum;

[0028] Figure 3 This is a cross-sectional schematic diagram of the device placed at the nasal septum;

[0029] Figure 4 for Figure 3 A partial enlarged view of part A;

[0030] Figure 5 Schematic diagram of the structure of the elliptical bonding sheet.

[0031] In the picture:

[0032] 1. First bonding sheet; 2. Second bonding sheet; 3. Magnetic ring; 4. Bump; 5. Drainage hole; 6. Drainage part. DETAILED DESCRIPTION

[0033] The following embodiments of the present invention are described in further detail with reference to the accompanying drawings and examples. The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0034] As attached Figure 1 To the attached Figure 5 As shown: The present invention provides a nasal septum mucosa magnetic suturing device, comprising a first bonding sheet 1 and a second bonding sheet 2;

[0035] A magnetic ring 3 is embedded in the inner side of the first bonding sheet 1 and the second bonding sheet 2. The first bonding sheet 1 and the second bonding sheet 2 attract each other, and the tissue contact surface pressure generated by the magnetic ring 3 is 15kPa-25kPa;

[0036] Magnetic ring 3 uses an N52-grade neodymium iron boron core with a titanium-plated surface. When the two rings are 2mm apart, they generate a pressure of 20±2kPa. This pressure was measured using a rabbit nasal septum mucosal pressure sensor. The pressure range is 15-25kPa, which is lower than the mucosal ischemia threshold of 40kPa but higher than the respiratory airflow impact force of 5kPa. This pressure can maintain normal blood supply to the tissue and is 5kPa higher than the respiratory airflow impact force, effectively preventing displacement caused by airflow disturbances.

[0037] The inner surfaces of the first and second bonding sheets 1 and 2 are arrayed with bumps 4. The bumps 4 are 50-150 μm high, 100-200 μm in diameter, and 200-300 μm apart. The bumps 4 are located on the surface of the first bonding sheet 1 that contacts the mucosa / graft, which may be fascia. The bumps 4 increase friction to prevent the graft (e.g., fascia) from slipping or wrinkling during compression. They also disperse pressure, avoiding excessive local pressure and reducing the overall compression requirement.

[0038] A drainage hole 5 is provided through the center of the first bonding sheet 1 and the second bonding sheet 2. The gaps between the protrusions 4 are connected to the drainage hole 5 to form a biological exudate channel. The drainage hole protrusions 4 are connected in a network, which can collect and discharge the exudate, allowing the exudate to flow to the drainage hole 5 for discharge; eliminating the risk of dead space, while allowing postoperative endoscopic observation of the healing condition; and reducing the total compression area to further ensure blood supply.

[0039] The first bonding sheet 1 and the second bonding sheet 2 are both provided with flow guides 6 on their circumferential sides.

[0040] The first bonding sheet 1 and the second bonding sheet 2 are circular or oval.

[0041] A method for using a nasal septum mucosa magnetic suturing device comprises the following steps:

[0042] S1. Cover the nasal septum wound with the graft;

[0043] S2. Press the convex surface of the first bonding sheet 1 onto the surface of the graft; select a circular bonding sheet to repair a circular perforation, and select an elliptical bonding sheet to repair a narrow perforation;

[0044] S3. Place the second adhesive patch 2 on the opposite side of the nasal septum, and the two sets of adhesive patches are attracted to each other to fix the graft;

[0045] S4, rotating the bonding sheet, adjusting the bonding position of the two sets of bonding sheets, and confirming that the exudate is discharged through the gaps between the protrusions 4, the guide portion 6, and the drainage holes 5;

[0046] S5. Remove the device from each side 7 days after placement.

[0047] From the above, we can see that when doctors perform nasal septum perforation repair surgery, they choose instruments according to the shape of the perforation: a round patch is used for a quasi-circular wound, and an oval patch is used for a narrow and long wound;

[0048] First, the graft fascia is evenly covered on the perforated wound surface. Then, the first bonding sheet 1 is taken and its inner side covered with bumps 4 is accurately pressed onto the graft surface. The bumps 4 will position the graft tissue in a distributed manner, forming a locking structure for the graft tissue and effectively preventing displacement.

[0049] Next, a second adhesive patch 2 is placed on the opposite side of the nasal septum. The two patches are automatically attracted to each other by the built-in magnetic ring 3. The magnetic force generated by the magnetic ring 3 instantly clamps the graft to the mucosa. The guide 6 is used to reduce the impact of respiratory airflow on the adhesive patch.

[0050] During the operation, it can be seen through the endoscope that the wound exudate is captured by the capillary siphon effect generated by the gaps between the protrusions 4, forming a dense liquid network that flows to the guide part 6. The liquid converges along the groove to the central drainage hole 5 for discharge; throughout the whole process, the graft is always firmly locked by the protrusions 4.

[0051] During the device's indwelling period, the magnetic ring 3 maintains compression, and the network of gaps between the protrusions 4 maintains drainage. For removal after seven days, the doctor gently lifts the edge of the adhesive patch, releasing the magnetic ring 3, and the new tissue has completely sealed the perforation.

[0052] Here are the steps:

[0053] 1. Preoperative Preparation

[0054] Instrument selection: select the fitting sheet based on the perforation size measured by nasal endoscopy:

[0055] Quasi-circular perforation: Diameter of bonding sheet = perforation diameter × 1.5 (e.g., for a 6mm perforation, choose a 9mm bonding sheet);

[0056] Narrow perforation: the long axis of the laminating piece = the perforation length + 3mm, the short axis = the widest part of the perforation + 2mm;

[0057] Check the magnetic ring's adsorption force: Place the two bonding sheets 5 cm apart and release them, they should be able to be adsorbed quickly;

[0058] Confirm that the drainage hole is unobstructed: flush the drainage hole with 3ml of normal saline, and the liquid should flow out within 5 seconds.

[0059] Graft preparation:

[0060] Autologous material: Temporalis fascia or middle turbinate mucosal flap is obtained and trimmed to extend 2-3 mm beyond the edge of the perforation;

[0061] Allogeneic material: Porcine pericardial patch needs to be pre-wetted (soaked in gentamicin saline for 5 minutes);

[0062] Special case: "Sandwich" grafts need to be prepared in layers (bottom layer patch + middle layer fat + surface layer fascia).

[0063] 2. Intraoperative Operation

[0064] For wound treatment, the left nasal septum was selected as the transplant bed, and a fresh wound was scraped out along the periphery of the perforation. The scar tissue at the edge of the perforation was then circularly removed to the perichondrial layer using a sickle-shaped knife. The wound was rinsed with 3% hydrogen peroxide solution, and finally, saline cotton pads were used to apply pressure to stop bleeding.

[0065] For graft placement, apply the fascia lata to the fresh wound surface and spread it flat over the perforation to ensure complete coverage. If the graft is curled, use the elbow suction tip dipped in a small amount of normal saline to gently press and flatten it.

[0066] Place the first bonding sheet 1 and clamp it with duckbill pliers, aligning the four protrusions vertically with the center of the graft. Gently press the bonding sheet to see if the protrusions 4 squeeze the graft. If the graft slips, adjust the position of the bonding sheet and apply pressure again.

[0067] The second patch 2 is adsorbed and placed in the corresponding position of the opposite nasal cavity; when it is close to the first patch 1, the magnetic ring 3 is automatically adsorbed, and the edge of the patch is gently pushed with the suction head to ensure complete alignment;

[0068] Inject 2 ml of normal saline to test the drainage function. The liquid should be discharged from the drainage hole 5 within 10 seconds. If the drainage is not smooth, adjust the angle of the patch or gently press the edge of the patch to promote liquid flow.

[0069] 3. Postoperative Management

[0070] On the same day, nasal endoscopy was performed every 30 minutes within 2 hours after surgery to check for bleeding from drainage hole 5 (normally, it should be light red bloody fluid); for pale mucosa at the edge of the patch; and for displacement of the patch after the patient sneezed.

[0071] Daily care: Moisten the nasal cavity with normal saline spray daily and avoid blowing the nose forcefully; take oral antibiotics for 3 days to prevent infection (cephalosporins + metronidazole); during nasal endoscopy, observe the healing of the graft through the drainage hole 5:

[0072] Day 3: The grafts are growing well and have normal color;

[0073] Day 5: The graft is tightly connected to the transplant bed and basically integrated;

[0074] For removal, on the 7th day, insert an ear dissector into the upper edge of patch 1 and gently pry it about 3 mm. After the magnetic force is released, use crocodile forceps to remove the patch in batches.

[0075] Observe the wound surface: In patients with good healing, continuous new mucosa can be seen and the perforation is completely closed.

[0076] Special situation handling:

[0077] Graft slippage: If the graft shifts after placing the first bonding sheet 1, immediately reset it with the suction head and increase the squeezing depth of the convex point 4 (extend the pressure time);

[0078] If there is a lot of bleeding, spray thrombin freeze-dried powder (1000U / 1ml) on the graft surface and temporarily press the patch for 3 minutes to promote coagulation.

[0079] If the bonding sheet is offset, use the angled suction head to press against the edge of the bonding sheet and slowly rotate it to the correct position; if the adsorption is not tight, remove the second bonding sheet 2 and replace it.

[0080] The extrusion depth of the protrusion 4 should be just enough to penetrate the surface of the graft (about 50-100 μm); the spacing between the small indentations formed should be uniform (about 200-300 μm).

[0081] During the adsorption process, keep the adhesive patch perpendicular to the nasal septum plane to avoid shear force. If the pressure after adsorption is too high (the patient complains of swelling and pain), replace the low-intensity magnetic ring (pressure 15kPa).

[0082] After surgery, flush drainage hole 5 with 1 ml of normal saline daily to prevent blockage; if the exudate is turbid, immediately take a sample for bacterial culture.

[0083] Example 1: Repairing a circular perforation with a circular bonding sheet

[0084] Three months after septoplasty, the patient was found to have an anterior perforation (6.5 mm in diameter), accompanied by dry nasal crusts and whistling sounds.

[0085] The surgical procedure is as follows:

[0086] Anesthesia and exposure: 1% tetracaine cotton pad for nasal anesthesia, 0.1% epinephrine cotton ball for vasoconstriction.

[0087] Nasal endoscope was passed into the right nasal cavity, and pale fibrosis was seen at the edge of the perforation.

[0088] Wound treatment: Use a sickle-shaped knife to excise the scar at the edge of the perforation to the bleeding wound to form a fresh ring.

[0089] The left temporalis fascia (8×8 mm) was taken and soaked in normal saline for later use.

[0090] Place the graft and the fitting sheet, hold the suction device in the left hand to absorb the bleeding, and use the micro forceps in the right hand to gently spread the fascia over the perforation (the edge exceeds 1.5mm). At this time, the fascia is slightly curled due to moisture.

[0091] Select a circular bonding sheet (9 mm in diameter), clamp the first bonding sheet 1 with duckbill pliers, and press the convex points 4 vertically toward the center of the fascia. Under the microscope, the fascia is instantly flattened by the convex points 4, and the curling of the edge disappears.

[0092] When the second patch 2 is placed in the left nasal cavity, the patient coughs and the patch slides to the bottom of the nose; the suction head is used to gently push the patch to the corresponding perforation position, and the magnetic ring 3 is automatically adsorbed, and the fascia is seen to be evenly stretched under the microscope.

[0093] Postoperative treatment: Follow-up visit on the 7th day showed no displacement of the patch under nasal endoscopy.

[0094] Removal operation: Insert an ear peeler into the upper edge of the fitting sheet 1 and gently pry it up 3mm. The magnetic force is released and the piece is separated instantly. The pink new mucosa is seen on the wound surface, completely sealing the perforation.

[0095] This process eliminates the complicated operation of traditional suturing through the automatic adsorption of the magnetic ring 3; the protrusion 4 squeezes the fascia to form a mechanical lock, and the graft remains zero displacement even when the patient coughs during the operation; the guide part 6 is oriented to form a three-level drainage channel with the drainage hole 5. The intraoperative water injection test showed that the exudate was completely discharged within 40 seconds, completely eliminating the risk of dead space infection; 7 days after the operation, the new mucosa was observed through the drainage hole 5 to have completely closed the perforation.

[0096] Example 2: Repairing a narrow perforation with an elliptical bonding patch

[0097] The patient had a posterior nasal septum perforation (3.2×11.5mm) with persistent nasal obstruction. The perforation was located at the posterior part of the perpendicular plate of the ethmoid bone, adjacent to the anterior wall of the sphenoid sinus, and the respiratory airflow velocity reached 3.1m / s (preoperative nasal acoustic reflex test).

[0098] Surgical steps: An elliptical fitting piece (long axis 14 mm / short axis 6 mm) was selected, and the long axis was deliberately placed horizontally (parallel to the nasal floor) during the operation.

[0099] Anti-airflow interference operation: After placing the first patch 1, the patch can be seen to vibrate slightly under the microscope when the patient takes a deep breath.

[0100] Special treatment of the graft: Due to the large perforation, a "sandwich" repair was used;

[0101] Bottom layer: porcine pericardial patch (15×12 mm);

[0102] Middle layer: autologous fat particle injection (to increase thickness);

[0103] Surface: temporalis fascia;

[0104] When the convex point 4 squeezes the fascia, fat particles overflow from the mesh and are promptly removed with a suction device.

[0105] Exudate observation: 2 hours after the operation, the patient sneezed and a small amount of bloody fluid flowed out from the drainage hole 5 without accumulation.

[0106] Nasal resistance monitoring: 0.92 Pa·s / ml before surgery → 0.35 Pa·s / ml after surgery (the diversion part reduced turbulence by 62%).

[0107] Follow-up after recovery: Nasal endoscopy was performed on the 5th day after surgery. A small amount of yellow scab was attached to the center of the graft, drainage hole 5 was unobstructed, and there was no sign of infection. When the patch was removed on the 7th day, epithelial metaplasia was seen (a sign of accelerated healing).

[0108] In this procedure, an elliptical fitting sheet with its long axis placed horizontally, combined with the groove design of the guide part 6, divides the respiratory airflow into laminar flow, reducing nasal resistance from 0.92 Pa·s / ml to 0.35 Pa·s / ml. The protrusion 4 successfully anchors the "sandwich" graft (pericardial patch + fat + fascia). During the operation, bleeding caused by sneezing is promptly discharged through the gap between the protrusion 4 and the drainage hole 5. The stable pressure maintained by the magnetic ring 3 enables epithelial metaplasia to be observed 5 days after surgery, accelerating healing.

[0109] This device locks the graft through the micro-anchoring effect of the protrusion 4 to avoid displacement and wrinkling, the automatic adsorption of the magnetic ring 3 realizes instant fixation without suture, the guide part 6 relieves the impact of airflow and guides the flow of exudate, and the drainage hole 5 continuously clears dead space effusion and allows healing monitoring, which greatly shortens the operation time of nasal septum repair surgery. The new tissue after surgery effectively seals the perforation, and the patient's respiratory function is effectively restored.

[0110] In the drawings of the embodiments disclosed in the present invention, only the structures involved in the embodiments disclosed in the present invention are involved. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of the present invention can be combined with each other.

[0111] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A nasal septum mucosa magnetic suturing device, characterized in that: include: A first bonding sheet (1) and a second bonding sheet (2); A magnetic ring (3) is embedded in the inner sides of the first bonding sheet (1) and the second bonding sheet (2), and the first bonding sheet (1) and the second bonding sheet (2) attract each other; convex points (4) are arranged in an array on the inner surfaces of the first bonding sheet (1) and the second bonding sheet (2); A drainage hole (5) is provided through the center of the first bonding sheet (1) and the second bonding sheet (2); the gaps between the protrusions (4) are connected to the drainage hole (5) to form a biological exudate channel.

2. A nasal septum mucosa magnetic suturing device according to claim 1, characterized in that: The first bonding sheet (1) and the second bonding sheet (2) are both provided with flow guides (6) on their circumferential sides.

3. A nasal septum mucosa magnetic suturing device according to claim 1, characterized in that: The height of the convex point (4) is 50-150 μm, the diameter is 100-200 μm, and the distance between adjacent convex points is 200-300 μm.

4. A nasal septum mucosa magnetic suturing device according to claim 1 or 3, characterized in that: The first bonding sheet (1) and the second bonding sheet (2) are circular.

5. A nasal septum mucosa magnetic suturing device according to claim 1 or 3, characterized in that: The first bonding sheet (1) and the second bonding sheet (2) are elliptical.

6. The nasal septum mucosa magnetic suturing device according to claim 1, characterized in that: The tissue contact surface pressure generated by the magnetic ring (3) is 15 kPa-25 kPa.

7. A method for using a nasal septum mucosa magnetic suturing device, used in conjunction with any one of claims 1-6, characterized in that: The following steps are involved: S1. Cover the nasal septum wound with the graft; S2, pressing the convex surface of the first bonding sheet (1) onto the surface of the graft; S3, placing a second patch (2) on the opposite side of the nasal septum, and the two patches are attracted to each other to fix the graft; S4, rotating the laminating sheets to adjust the laminating positions of the two sets of laminating sheets; S5. Remove the device from each side 7 days after placement.

8. A method for using the nasal septum mucosa magnetic suturing device according to claim 7, characterized in that: In the step S2, a circular bonding sheet is selected to repair a quasi-circular perforation, and an elliptical bonding sheet is selected to repair a narrow and long perforation.

9. A method for using the nasal septum mucosa magnetic suturing device according to claim 7, characterized in that: In the above-mentioned S4, the drainage hole (5) is observed through an endoscope to confirm that the exudate is discharged through the gap between the protrusion (4), the guide part (6), and the drainage hole (5).

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