A suture anchor occlusion system for large bore vessel puncture site closure

Abstract

The application relates to the technical field of medical devices, in particular to a suture anchoring and plugging system for large-diameter blood vessel puncture points, which comprises a guide wire, a conveying catheter is sleeved outside the guide wire, a plugging sheet is arranged in the inside of the conveying catheter, the plugging sheet is movably arranged in a folded and compressed state at the front end of the inside of the conveying catheter; a pushing handle is arranged at the rear end of the conveying catheter, the pushing handle is detachably connected with the plugging sheet through an inner rod arranged in the inside of the conveying catheter; four preset suture units are uniformly arranged on the plugging sheet, the preset suture unit comprises a connecting ring; a suturing device is arranged in cooperation with the guide wire, four suturing needles are arranged at the tail end of the suturing device; four connecting rings are preset on the plugging sheet, and the suturing device with a four-needle structure is used in cooperation, so that the suturing operation of the four connecting rings can be synchronously completed through one-time firing, the operation efficiency is improved, and the operation difficulty is reduced; meanwhile, the four connecting rings make the stress of the plugging sheet more balanced, and the impact resistance is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a suture anchoring and occlusion system for closing large-diameter vascular puncture points. Background Technology

[0002] In clinical medical procedures, various diagnostic and treatment scenarios require percutaneous puncture of large-diameter arteries, typically necessitating the insertion of a 5-25 Fr cannula or sheath. Upon removal, this leaves a 2-10 mm diameter tear in the arterial wall, requiring rapid hemostasis and suturing. Traditional hemostasis methods include manual compression and pre-fabricated purse-string sutures, but these methods have the following drawbacks:

[0003] Artificial compression: It needs to be sustained for 15-30 minutes, and the force is not easy to control. The incidence of hematoma or pseudoaneurysm is 8-15%. Prolonged compression increases patient discomfort and the risk of limb ischemia.

[0004] Pre-placed purse-string sutures: These sutures are mostly non-absorbable polypropylene sutures, which, if left around blood vessels for a long time, can lead to foreign body granulomas or infection risks.

[0005] While some existing vascular closure devices can quickly suture ruptures in the blood vessel wall, several drawbacks remain:

[0006] Perclose ProGlide (suture device): This device directly closes vascular ruptures by suturing and is widely used for 6-8 Fr puncture sites. However, for larger diameter puncture sites of 14-25 Fr, 2-3 instruments are usually required for pre-placed suturing, which is complex and direct suturing can lead to excessively tight apposition of the vessel walls, posing a risk of local stenosis.

[0007] Prostar XL: Although it has a four-needle suture function, the suture is not absorbable and there is no occlusion plate to assist it. Directly suturing large-diameter ruptures still carries the risk of stenosis.

[0008] MANTA (collagen plug): Non-absorbable, it occupies subcutaneous sinus tracts and has a high incidence of complications.

[0009] Angio-Seal (anchor plate + collagen plug + suture): complex structure, some parts are non-absorbable, and the suture knotting process is cumbersome.

[0010] Vivasure PerQseal (Absorbable Patch): Fully absorbable, seamless anchoring, and fixed solely by the patch's own tension, it is insufficient to prevent dislodgement in arterial high-pressure pulsating blood flow.

[0011] Common defects: Existing large-diameter closure devices either cause stenosis due to suturing, or the anchoring of the occluder is unreliable, or foreign body residue causes discomfort or complications, and it is impossible to complete the anchoring of the occluder at multiple points uniformly in a single operation. Summary of the Invention

[0012] The purpose of this invention is to provide a suture anchoring occlusion system suitable for large-diameter blood vessels, which can avoid stenosis caused by direct suturing of the blood vessel wall and can firmly and evenly anchor the occlusion piece to the inner wall of the blood vessel at the puncture point of the large-diameter blood vessel.

[0013] To achieve the above objectives, the present invention adopts the following technical solution: A suture anchoring and occlusion system for closing large-diameter vascular puncture sites includes a guidewire, a delivery catheter sleeved on the outside of the guidewire, an occlusion plate disposed inside the delivery catheter in a folded and compressed state at the front end of the delivery catheter, a push handle disposed at the rear end of the delivery catheter, an inner rod connected to the push handle, the inner rod passing through the delivery catheter and the end of the inner rod being detachably connected to the occlusion plate, four pre-placed suture units disposed on the occlusion plate, the four pre-placed suture units being evenly distributed along the edge of the occlusion plate, and a suture device cooperating with the guidewire, the end of the suture device being provided with four suture needles cooperating with the four pre-placed suture units.

[0014] Preferably, the pre-installed suture unit includes a connecting ring, which is connected to the sealing plate via sutures.

[0015] Preferably, the sealing plate has a circular or elliptical structure when unfolded, and 4-6 elastic barbs are evenly arranged on the edge of the sealing plate.

[0016] Preferably, the end of the suture device away from the suture needles is provided with a firing trigger, which is connected to the four suture needles respectively through a synchronous push block; the front end of the suture needles is provided with an elastic claw.

[0017] Preferably, the occlusion patch is made of a biodegradable material and is coated with a drug coating.

[0018] Preferably, the drug coating has multiple layers, and the degradation time of each drug coating layer decreases sequentially from the inside to the outside.

[0019] Preferably, the connecting ring is made of a magnetically degradable material, and both the connecting ring and the suture needle are provided with radiopaque microparticles.

[0020] The beneficial effects of this invention are: This invention uses an internal occlusion patch to seal vascular ruptures. The suture is only used to fix the occlusion patch from the outside of the blood vessel wall, rather than directly aligning the blood vessel walls, thus preserving the original diameter of the blood vessel and preventing the blood vessel from becoming narrowed due to suture sealing.

[0021] This invention employs a four-point uniform anchoring method to anchor the sealing plate, ensuring uniform force distribution in all directions and effectively improving its anti-detachment performance. Four pre-set suture units around the sealing plate align with the four suture needles on the suturer for simultaneous suturing, resulting in uniform force distribution during the suturing process. Compared to traditional two-anchor point suturing, this significantly enhances the sealing plate's impact resistance.

[0022] This invention employs a method of simultaneous firing of multiple suture needles to capture and suture pre-set suture units. Compared to the single-needle firing and multi-stage operation mode of traditional suture devices, this invention only requires one firing to complete the capture and suturing of all four pre-set suture units. This not only significantly improves suturing efficiency and reduces surgical time, but also avoids the problem of uneven stress on the occlusion piece caused by separate suturing, which affects the difficulty of subsequent suturing.

[0023] This invention coats the occlusion patch with multiple layers of drug coating and sets different release times for each layer, achieving staggered drug release and realizing the drug release logic of "early anti-infection → mid-term anti-inflammation → late-term repair promotion". It can release drugs in a targeted manner for different effects required at different times after surgery, thereby accelerating postoperative recovery efficiency.

[0024] This invention features elastic barbs around the occlusion patch for anchoring, which helps to fix the patch after release and before the suture needle is fired, preventing displacement or detachment and reducing reliance on suture tension, thus lowering the risk of vascular stenosis. The connecting ring is made of magnetic biodegradable material, which can cooperate with the suture needle to guide the suture needle to quickly and accurately align with the connecting ring, effectively solving the problem of difficult alignment in high-pressure blood flow and reducing the difficulty of operation. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure before the blocking piece is pushed in Embodiment 1 of the present invention; Figure 2 This is a schematic diagram of the sealing plate structure in Embodiment 1 of the present invention; Figure 3 This is a schematic diagram of the suture device structure in Embodiment 1 of the present invention; Figure 4 This is a schematic diagram of the internal structure of the suture device in Embodiment 1 of the present invention; Figure 5 This is a schematic diagram of the sealing plate structure in Embodiment 2 of the present invention; Figure 6 This is a cross-sectional schematic diagram of the drug coating on the occlusive patch in Embodiment 3 of the present invention. Figure 7 This is a flowchart illustrating the pushing and unfolding of the blocking piece in Embodiment 5 of the present invention; Figure 8 This is a flowchart of the stitcher capturing the connecting ring in Embodiment 5 of the present invention; Figure 9 This is a schematic diagram of the structure of the occlusion patch after it is sutured to the inner wall of the blood vessel in Embodiment 5 of the present invention; In the diagram: 1. Guide wire; 2. Delivery catheter; 3. Push handle; 4. Occlusion plate; 5. Connecting ring; 6. Suture device; 7. Suture needle; 8. Firing trigger; 9. Synchronous pusher; 10. Elastic barb; 11. Antibiotic layer; 12. Anti-inflammatory layer; 13. Microsphere layer. Detailed Implementation

[0026] Example 1

[0027] The following is a further explanation of the present invention in conjunction with specific embodiments, such as... Figure 1 As shown, this embodiment is a suture anchoring and occlusion system for closing large-diameter vascular puncture points. It includes a guide wire 1, which is used to assist in the positioning and delivery of various tools. One end of the guide wire 1 extends into the vascular wall through a rupture in the vascular wall, while the other end extends out of the vascular wall.

[0028] A delivery conduit 2 is sleeved on the outside of the guide wire 1, and a sealing plate 4 is provided at the front end of the delivery conduit 2. The sealing plate 4 is in a folded state inside the delivery conduit 2, and it is connected to a push handle 3 located outside the other end of the delivery conduit 2 through an inner rod. The push handle 3 can push the sealing plate 4 to the outside of the delivery conduit 2 and release it, so that the sealing plate 4 in the folded state becomes an unfolded state.

[0029] The occlusion plate 4 in its deployed state Figure 2 As shown, it is a circular or elliptical sheet structure with four connecting rings 5 ​​evenly arranged at the edge of the sealing sheet; the connecting rings 5 ​​are ring-shaped structures and are connected to the sealing sheet 4 by stitches.

[0030] like Figure 3 As shown, in order to suture and fix the occlusion piece 4 to the inner wall of the blood vessel, this embodiment uses a four-needle synchronous suture device 6, with four suture needles 7 connected to the front end of the suture device 6; as Figure 4 As shown, the suture needle 7 is connected to the firing trigger 8 located at the rear end of the suturer 6 via the synchronous push block 9; by firing the trigger 8, the four suture needles 7 can be fired forward synchronously to puncture the blood vessel wall and cooperate with the connecting ring 5.

[0031] The occlusion plate 4, connecting ring 5, and suture are all made of biodegradable materials, which will degrade and be absorbed on their own after being sutured and fixed to the inner wall of the blood vessel for a period of time, without leaving any permanent foreign bodies.

[0032] Example 2

[0033] The difference between this embodiment and Embodiment 1 is that, as Figure 5 As shown, in this embodiment, an elastic barb 10 structure is provided at the edge of the sealing piece 4.

[0034] The elastic barb 10 can help fix the occlusion piece 4 to the inner wall of the blood vessel after the occlusion piece 4 is unfolded and before the suturer 6 performs suturing, so as to prevent the occlusion piece 4 from falling off or shifting, which would affect the cooperation between the suturer 6 and the occlusion piece 4.

[0035] Example 3

[0036] The difference between this embodiment and embodiment 2 is that the guidewire 1 in this embodiment is made of stainless steel / nickel-titanium alloy, the delivery catheter 2 is made of medical polyurethane / Pebax material, and the push handle is made of ABS plastic.

[0037] The sealing plate 4 is made of PCL (70%) / PLGA (30%) blend material, and its degradation cycle is 4-6 months; the diameter of the unfolded sealing plate 4 is 3-15mm and the thickness is 0.3-0.5mm; 4-6 elastic barbs 10 are set on the edge, with a length of 0.5-1mm.

[0038] Each connecting ring 5 in the pre-placed suture unit has an inner diameter of 0.3-0.5 mm and is integrally injection molded or sewn to the sealing sheet 4 through a PLGA monofilament with a diameter of 0.25 mm. The connecting ring 5 uses PLGA material as the matrix and is doped with Fe3O4 magnetic nanoparticles to achieve a magnetic guiding effect.

[0039] The delivery catheter 2 has an outer diameter of 5 Fr and a length of 45 cm. It is made of Pebax material, with an outer sheath and an inner push rod at the front end, and depth markings are provided on the push handle 3.

[0040] The tip of the suture needle 7 of the suture device 6 is equipped with an elastic claw, which is made of shape memory alloy.

[0041] In this embodiment, the outer surface of the blocking patch 4 is coated with multiple layers of drug coating, such as... Figure 6 As shown, this embodiment contains three drug coating layers, from the outside to the inside: an antibiotic layer 11, an anti-inflammatory layer 12, and a microsphere layer 13. The antibiotic layer 11 contains chitosan / gentamicin (2.0 mg / cm²), added via impregnation, with a degradation time of 24 hours. The anti-inflammatory layer 12 contains PLGA (50:50) / dexamethasone (0.5 mg / cm²), added via spraying, and degrades within 1-4 weeks. The microsphere layer 13 contains VEGF (1.0 μg / cm²) encapsulated in PLGA microspheres (50 μm), mixed into a PCL matrix and injection molded, and releases within 4-12 weeks.

[0042] Example 4

[0043] The difference between this embodiment and embodiment 3 is that the occlusion plate 4 in this embodiment is shaped as a lobed or porous mesh, and the number of connecting rings 5 ​​is set to 6-8; the material is replaced with PDO or chitosan; the drug coating on the occlusion plate 4 is replaced with bFGF, PDGF or exosomes; and imaging microparticles are set on both the connecting rings 5 ​​and the suture needle 7 to improve the visibility of the operation.

[0044] Example 5

[0045] This embodiment describes a method for closing large-diameter vascular puncture sites based on the system proposed in the above embodiments. Figure 7-8 As shown, the specific steps include: S1. Prefabricated guidewire: Insert guidewire 1 into the blood vessel from the rupture site; S2. Remove indwelling objects: Remove all indwelling objects except guidewire 1 from the blood vessel and advance delivery catheter 2 along guidewire 1 to the rupture site of the blood vessel. S3, Delivery of Occlusion Piece: The occlusion piece 4 is pushed into the blood vessel along the guide wire 1 using the push handle 3; S4. Release the occlusion piece: Release the occlusion piece 4 by pushing the handle 3, so that the occlusion piece 4 unfolds inside the blood vessel and covers the rupture site from the inside. S5. Withdraw the delivery catheter: Withdraw the delivery catheter 2 along the guide wire 1; S6. Capture the pre-placed suture unit: The suture device 6 is advanced along the guide wire 1 to the rupture site on the outside of the blood vessel. After aligning the four suture needles 7 with the four connecting rings 5 ​​on the four pre-placed suture units, the suture needles 7 are inserted into the blood vessel, so that the connecting rings 5 ​​are fitted over the elastic claws at the front end of the suture needles 7. The trigger 8 is fired to activate the elastic claws, so that the elastic claws on the four suture needles 7 hook the four connecting rings 5 ​​respectively, thereby capturing the pre-placed suture unit. S7. Pull out the suture and tie a knot: Retract the suture device 6, pull out the connecting rings 5 ​​to the outside of the blood vessel wall, and tie the four connecting rings 5 ​​to the outside of the blood vessel wall using the suture, anchoring the occlusion piece 4 to the inside of the blood vessel wall; the effect of the occlusion piece 4 after suturing and anchoring is as follows. Figure 9 As shown, the suture knot is placed outside the blood vessel wall, while the occlusion piece 4 completely covers the blood vessel rupture and adheres to the inner wall of the blood vessel. The four connecting rings 5 ​​are pulled out to the outside of the blood vessel wall and sutured and knotted. The suture connecting the occlusion piece 4 and the connecting rings 5 ​​passes through the hole left on the blood vessel wall after the suture needle 7 is punctured, which firmly fixes the occlusion piece 4 to the inner wall of the blood vessel and provides a uniform anchoring force. S8. Withdraw instruments: Withdraw instruments such as suture device 6 and guide wire 1 in sequence.

[0046] After practical testing, the method proposed in this embodiment, using the system proposed in Examples 1-4, for large-diameter vascular puncture site closure surgery, has the following technical effects:

[0047] Immediate hemostasis success rate: 100% in animal experiments (pig femoral artery, 17Fr puncture, n=10), median operation time 1.5 minutes.

[0048] Vascular stenosis rate: Angiography at 4 weeks postoperatively showed that the vascular diameter decreased by 2.1±1.0% in the anchored occlusion group and by 15.6±3.8% in the conventional direct suture group (p<0.01).

[0049] Anti-displacement effect: In the in vitro pulsatile blood flow model (120 / 80 mmHg, 60 beats / min), the four-point anchorage showed no displacement after 72 hours, while in the two-point control group, 3 / 10 displaced within 12 hours.

[0050] Healing quality: Two weeks post-surgery, the newly formed endothelium completely covered the vessel, with no thrombosis; eight weeks post-surgery, the occlusion patch partially degraded, and the vessel wall structure remained intact.

[0051] Drug release: 85% of antibiotics are released in 24 hours, 70% of anti-inflammatory factors are released in 7 days, and 50% of VEGF is released in 2 weeks and 90% in 6 weeks, matching the healing cycle.

[0052] Operational efficiency: The number of operation steps is reduced by 50%, and the total time is shortened by about 40%.

[0053] The above description is merely a further explanation of the present invention in conjunction with specific embodiments. All descriptions made do not imply any limitation on the scope of protection of the present invention. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology 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 suture anchoring and occlusion system for closing large-diameter vascular puncture sites, comprising a guidewire, with a delivery catheter sleeved on the outside of the guidewire, characterized in that: The delivery conduit is internally equipped with a sealing plate, which is folded and compressed and movably disposed at the front end of the delivery conduit. A push handle is located at the rear end of the delivery conduit, and an inner rod is connected to the push handle. The inner rod passes through the interior of the delivery conduit, and its end is detachably connected to the sealing plate. Four pre-placed suture units are provided on the sealing plate, evenly distributed along its edge. A suture device is provided in conjunction with the guide wire, and its end is equipped with four suture needles that cooperate with the four pre-placed suture units.

2. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 1, characterized in that: The pre-placed suture unit includes a connecting ring, which is connected to the sealing plate via sutures.

3. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 2, characterized in that: The sealing plate has a circular or elliptical structure when unfolded, and 4-6 elastic barbs are evenly arranged on the edge of the sealing plate.

4. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 3, characterized in that: The end of the suture device away from the suture needles is provided with a firing trigger, which is connected to the four suture needles respectively through a synchronous push block; the front end of the suture needles is provided with an elastic claw.

5. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 4, characterized in that: The occlusion patch is made of biodegradable material and is coated with a drug coating.

6. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 5, characterized in that: The drug coating has multiple layers, and the degradation time of each drug coating layer decreases sequentially from the inside to the outside.

7. The suture anchoring and occlusion system for closing large-diameter vascular puncture sites according to claim 5, characterized in that: The connecting ring is made of a magnetically biodegradable material, and both the connecting ring and the suture needle are provided with radioactive microparticles.

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