Medical rapid hemostasis device

Abstract

The invention discloses a medical rapid hemostasis device, and belongs to the technical field of hemostats. The medical rapid hemostasis device comprises a composite suture, and the composite suture is used for conducting a blood coagulation effect on blood vessels; the sealing plug can complete radial expansion plugging in a self-adaptive manner; and the anchoring device is used for connecting the composite suture and the sealing plug, so that the sealing plug sleeves the composite suture and pops up to a blood vessel groove to complete blood vessel sealing. The thrombin targeted release shortens the blood coagulation time; the sealing plug expands in a self-adaptive mode to cover a 1-5 mm blood vessel crevasse, and the sealing qualification rate is high. Operation is simplified, operation steps are reduced from seven steps to three steps through integrated design, and the first-aid efficiency is improved. The sodium alginate-PCL suture is completely degraded in vivo within 28 days, so that a secondary taking-out operation is avoided; the ePTFE-fibrinogen compound promotes endothelial crawling, and the revascularization rate after 6 weeks is larger than 90%. And the economic benefit is remarkable: the blood transfusion demand is reduced by timely and effective hemostasis.

Description

Technical Field

[0001] The present invention relates to the field of hemostat, in particular to a medical rapid hemostasis device. Background Art

[0002] Generally, after a clinical interventional surgery, the puncture sites on the arteries and veins need to be treated. In general, the treatment of puncture sites on venous vessels is relatively simple; the treatment of puncture sites on arterial vessels is more complicated, and the treatment method generally uses finger pressure or mechanical compression to stop bleeding. With the development of science and technology, the use of vascular suture devices to treat puncture sites on arterial vessels has been widely used in clinical practice. At present, traditional suture hemostasis relies on the surgeon's experience through simple mechanical ligation, and the ligation failure rate on moist tissue surfaces (such as liver wounds) is as high as 32%; thrombin spray hemostasis: free thrombin is easily dispersed by the blood flow and the effective action time is less than 30 seconds, and it cannot form a stable blood clot in active bleeding. It can be seen that the technology for rapid hemostasis needs to be improved.

[0003] Therefore, developing a medical rapid hemostasis device to improve the convenience and functionality of flushing has become an urgent need in the medical field. Summary of the Invention

[0004] The purpose of the present invention is to provide a medical rapid hemostasis device to solve the problems raised in the above background technology.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solutions: a medical rapid hemostasis device, comprising a composite suture, which is used to perform coagulation on a blood vessel; a sealing plug, which can adaptively complete radial expansion and blocking; and an anchoring device, which is used to connect the composite suture and the sealing plug, so that the sealing plug is ejected from the composite suture to the slope of the blood vessel to complete the blocking of the blood vessel.

[0006] As a further optimization of this technical solution, the composite suture includes a core layer, sodium alginate fibers and thrombin-loaded PEG hydrogel microspheres, the outside of the core layer is wrapped with sodium alginate fibers, and the inside of the sodium alginate fibers is filled with thrombin-loaded PEG hydrogel microspheres.

[0007] As a further optimization of the technical solution, the thrombin loading capacity of the PEG hydrogel microspheres is 4000-6000 IU / cm, and the particle size distribution of the microspheres is 50-100 μm.

[0008] As a further optimization of the present technical solution, the sealing plug is composed of a shape memory alloy mesh and a drug-loaded ePTFE layer. The shape memory alloy mesh is wrapped around the outside of the drug-loaded ePTFE layer. Guide grooves are respectively provided on both sides of the outside of the shape memory alloy mesh, and a central channel is also provided in the sealing plug.

[0009] As a further optimization of the present technical solution, the expansion ratio of the shape memory alloy mesh is 1:3, and the applied radial pressure is ≥80 kPa.

[0010] As a further optimization of this technical solution, the fibrinogen concentration in the thrombin-fibrinogen complex impregnated with the drug-loaded ePTFE layer is 180-220 mg / cm 3 .

[0011] As a further optimization of the present technical solution, the anchoring device includes a detachable sleeve and a snap spring assembly. The snap spring assembly is installed on the upper and lower ends of one side of the sleeve. The other end of the snap spring assembly is detachably connected to the composite suture. After connection, the sealing plug and the composite suture achieve synergistic effects of mechanical anchoring and chemical hemostasis.

[0012] Compared with existing technologies, the medical rapid hemostasis device of the present invention has the following beneficial effects: Breakthrough in hemostatic efficacy: Targeted release of thrombin shortens clotting time to 1 / 6 of that of traditional methods (measured in a porcine femoral artery model, <30 seconds); adaptive expansion of the closure plug covers 1-5mm vascular ruptures, increasing the sealing qualification rate from 68% to 98%. Revolutionary simplification of operation: The integrated design reduces the number of operation steps from 7 to 3, shortening training time from 8 hours to 30 minutes; and single-handed operation makes field first aid possible. Material innovation advantages: Sodium alginate-PCL sutures completely degrade in the body within 28 days, eliminating the need for secondary removal surgery; the ePTFE-fibrinogen complex promotes endothelial creep, resulting in a vascular recanalization rate of >90% after 6 weeks. Significant economic benefits: Timely and effective hemostasis reduces the need for blood transfusions. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 It is a structural schematic diagram of the present invention;

[0014] Figure 2 This is a schematic diagram of the sealing plug structure of the present invention;

[0015] Figure 3 It is a schematic structural diagram of the anchoring device of the present invention;

[0016] Figure 4 Schematic diagram of the cross-sectional structure of the composite suture of the present invention.

[0017] In the figure: 100, composite suture; 110, core layer; 120, sodium alginate fiber; 130, PEG hydrogel microspheres; 200, sealing plug; 210, shape memory alloy mesh; 220, drug-loaded ePTFE layer; 230, guide groove; 240, central channel; 400, anchoring device; 410, sleeve; 420, snap spring assembly. DETAILED DESCRIPTION

[0018] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0019] Example 1:

[0020] See also Figures 1 to 4 This embodiment provides a technical solution: a medical rapid hemostasis device, including a composite suture 100, a sealing plug 200, and an anchoring device 400. The composite suture 100 is used to perform coagulation on the blood vessel; the sealing plug 200 can adaptively complete radial expansion and blocking; the anchoring device 400 is used to connect the composite suture 100 and the sealing plug 200, so that the sealing plug 200 is put on the composite suture 100 and pops out to the bevel of the blood vessel to complete the blocking of the blood vessel.

[0021] More specifically, through the synergistic effect of the thrombin sustained-releasing suture: the composite suture 100 and the adaptive sealing plug 200, the anchoring device 400 is used to connect the composite suture 100 and the sealing plug 200, so that the sealing plug 200 is put on the composite suture 100 and pops out to the slope of the blood vessel to complete the blocking of the blood vessel, thereby realizing the dual hemostasis mechanism of mechanical blocking and chemical coagulation, breaking through the efficiency bottleneck of traditional hemostasis technology.

[0022] In a specific implementation, the composite suture 100 includes a core layer 110, sodium alginate fibers 120 and thrombin-loaded PEG hydrogel microspheres 130. The outside of the core layer 110 is wrapped with sodium alginate fibers 120, and the inside of the sodium alginate fibers 120 is filled with thrombin-loaded PEG hydrogel microspheres 130.

[0023] More specifically, the sodium alginate fiber 120 is spirally wound around the surface of the core layer 110 .

[0024] In a specific implementation, the thrombin loading amount of the PEG hydrogel microspheres 130 is 4000-6000 IU / cm, and the particle size distribution of the microspheres is 50-100 μm.

[0025] In specific implementation, the sealing plug 200 is composed of a shape memory alloy mesh 210 and a drug-loaded ePTFE layer 220. The shape memory alloy mesh 210 is wrapped around the outside of the drug-loaded ePTFE layer 220. Guide grooves 230 are respectively provided on both sides of the outside of the shape memory alloy mesh 210. A central channel 240 is also provided in the sealing plug 200.

[0026] More specifically, the shape memory alloy mesh is a mesh structure that takes on a slender cylindrical shape (1mm diameter) in its contracted state and an umbrella-like shape (3mm diameter) in its expanded state. First, in the contracted state (before implantation), the plug 200 takes on a slender cylindrical shape, with the outer shape memory alloy mesh 210 tightly attached to the drug-loaded ePTFE layer 220. Second, in the expanded state (after implantation), the outer shape memory alloy mesh 210 unfolds into an umbrella-like structure, while the drug-loaded ePTFE layer 220 expands to fill the vascular rupture.

[0027] In a specific implementation, the expansion ratio of the shape memory alloy mesh 210 is 1:3, and the applied radial pressure is ≥80 kPa.

[0028] In a specific implementation, the thrombin-fibrinogen complex impregnated with the drug-loaded ePTFE layer 220 has a fibrinogen concentration of 180-220 mg / cm 3 .

[0029] In specific implementation, the anchoring device 400 includes a detachable sleeve 410 and a snap spring assembly 420. The snap spring assembly 420 is installed at the upper and lower ends of one side of the sleeve 410. The other end of the snap spring assembly 420 is detachably connected to the composite suture 100. After connection, the sealing plug 200 and the composite suture 100 achieve synergistic effects of mechanical anchoring and chemical hemostasis.

[0030] More specifically, the buckle spring assembly 420 includes a buckle, a push rod, and a spring. The buckle is connected to the sleeve 410. One end of the spring is connected to the push rod and the other end is connected to the sleeve 410. The sleeve 410 is sleeved on the composite suture 100. After suturing, the sealing plug 200 is sleeved on the outside of the composite suture 100. By pushing the push rod, the spring pops out and then pushes the sealing plug 200 at one end to pop out and enter the blood vessel groove.

[0031] This medical rapid hemostasis device: The core layer 110 of the thrombin composite suture 100 is a polycaprolactone (PCL) monofilament with a diameter of 0.2-0.5mm, and the surface is spirally wrapped with sodium alginate fibers 120; the thrombin sustained-release layer 130: freeze-dried thrombin powder (5000IU / cm) is embedded in polyethylene glycol (PEG) hydrogel microspheres (particle size 50-100μm), and the microspheres are fixed to the gaps between the sodium alginate fibers by electrostatic adsorption; the trigger release mechanism of the above technical solution: after contact with blood, the PEG hydrogel dissolves, releasing 50% of the thrombin within 30 seconds and completely releasing it within 5 minutes (compliant with ISO 10993-5 biocompatibility standards).

[0032] The outer layer of the adaptive sealing plug 200 is a shape memory alloy mesh 210, which is a shape memory alloy (nitinol) woven mesh with a mesh density of 80 mesh and an adaptive diameter adjustment ratio of 1:3 after expansion. The inner layer is a drug-loaded ePTFE layer 220 of expanded polytetrafluoroethylene (ePTFE) with a porosity of 85% and impregnated with a thrombin-fibrinogen complex (concentration 200 mg / cm 3 ); The dual-mode occlusion mechanism of the above technical solution: mechanical occlusion: the nitinol mesh expands to the edge of the rupture at body temperature, applying a radial pressure ≥80kPa; chemical occlusion: blood penetrates the ePTFE pores to trigger fibrinogen cross-linking, forming a thrombus-like structure (clotting time <60 seconds).

[0033] Example 2 (liver wound hemostasis):

[0034] A 0.3mm diameter composite suture 100 was matched with a sealing plug 200 (1mm diameter in the contracted state). The device was punctured and implanted into the bleeding point of the liver parenchyma. The suture was pulled to expand the sealing plug to 3mm, completely covering the 3.5mm rupture. The knotted suture was then subjected to a tension of 0.6N. Within 15 seconds, 800 IU of thrombin was released, and the bleeding volume decreased from 120 mL / min to 5 mL / min.

[0035] Example 3 (First aid for femoral artery rupture):

[0036] The device is preloaded onto a 14G catheter using a rapid loader. After percutaneous puncture to the rupture, the plug is pushed 200mAway and then automatically expands, achieving a radial pressure of 120kPa. Fibrinogen cross-links to form a thrombus-like structure, which, combined with suture ligation, shortens hemostasis time to 22 seconds (compared to >180 seconds with traditional methods).

[0037] Specific experimental content and data details of the pig femoral artery model:

[0038] Experimental design:

[0039] 1.1. Experimental subjects: Healthy adult Landrace pigs (weight 30-40 kg, n=12) were fasted for 12 hours before surgery and anesthetized with isoflurane inhalation (maintenance concentration 1.5-2%) plus intravenous propofol (4-6 mg / kg / h).

[0040] 1.2 Ethical review: This experiment was approved by the IACUC (Institutional Animal Care and Ethics Committee) (No. IACUC-2023-0715).

[0041] 2.1 Model establishment: bilateral femoral arteries were exposed, blood flow was temporarily blocked using vascular clamps, and a standardized puncture wound (area ≈ 12.56 mm) was created using a 4.0 mm diameter puncture needle. 2) to simulate grade III arterial bleeding (bleeding volume > 100 mL / min). 2.2. Injury Verification: Laser Doppler flowmetry (PeriFlux 5000) confirmed that the blood flow rate at the rupture was 120 ± 15 mL / min.

[0042] Experimental grouping and operation

[0043] 1.1. Experimental group (n=6), using the hemostatic device of the present invention (thrombin composite suture + adaptive sealing plug), the time from the exposure of the rupture to the completion of the device implantation was ≤10 seconds.

[0044] Operation process:

[0045] Step 1: implanting a sealing plug (200) into the proximal end of the rupture via a catheter;

[0046] Step 2: pulling the suture (100) to trigger expansion of the closure plug;

[0047] Step 3: Tie a knot to secure the suture and record the time of hemostasis.

[0048] 1.2. Control group (n=6): traditional hemostasis scheme (simple suture ligation + local thrombin spraying), the operation was performed by the same surgeon.

[0049] Measurement parameters

[0050] 1. Main indicators

[0051] 1.1. Hemostasis time: The time from when the device contacts the wound until the bleeding volume decreases to ≤5 mL / min (the threshold is based on the ATLS trauma emergency guidelines). 1.2. Bleeding volume: The amount of blood absorbed by the gauze is measured by weighing (1 g ≈ 1 mL).

[0052] 2. Secondary indicators

[0053] 2.1. Thrombin Release: Detect the thrombin concentration (IU / mL) in the blood surrounding the rupture using an ELISA kit (Human Thrombin ELISA Kit). 2.2. Blood Flow Recovery Rate: Evaluate vascular patency using Doppler ultrasound 24 hours after surgery.

[0054] Experimental results

[0055]

[0056] Table 1

[0057] Key data analysis

[0058] The scientific basis for hemostasis time < 30 seconds: the median hemostasis time of the experimental group was 24.3 seconds, which was mainly attributed to: the radial pressure (80kPa) of the sealing plug (200) directly compressing the rupture; the targeted sustained release of thrombin (release amount of 850IU in 5 minutes), which is 2.8 times higher than the concentration of the traditional spraying method.

[0059] Limitations of the control group: Traditional suture ligation relies on physical compression, and thrombin is rapidly lost due to blood flow flushing, resulting in prolonged hemostasis time (>3 minutes).

[0060] Differences in vascular patency: The ePTFE material in the experimental group promoted endothelial cell crawling (HE staining showed that the endothelial coverage rate reached 70% 2 weeks after surgery), while thrombus formation was easy around the suture in the control group.

[0061] Experimental Verification Conclusion: Effectiveness: In a porcine femoral artery grade III bleeding model, the present invention significantly outperformed the traditional approach in terms of hemostasis time, bleeding volume, and vascular patency (p < 0.05). Repeatability: Among the 12 experimental groups, 11 achieved hemostasis time < 30 seconds (91.7% success rate), and only one case had hemostasis time extended to 34 seconds due to deviation in the rupture position. Transformation Value: The data supports that the device complies with the requirements of the "Guidelines for the Technical Review of Animal Experiments for Medical Devices" and can be advanced to the clinical trial stage (NMPA Class III device application path).

[0062] When using this medical rapid hemostasis device, the specific operating procedures are as follows:

[0063] Synergistic system: The composite suture 100 is connected to the sealing plug 200 through a detachable snap spring assembly, and the implementation can be divided into the following three steps: Step 1: Insert the composite suture 100 into the central channel 240 of the sealing plug 200 and implant it axially along the vascular rupture; Step 2: Pull the composite suture 100 to position the sealing plug 200, and the body temperature triggers its radial expansion to block; Step 3: Tie a surgical knot with the composite suture 100 at the proximal end of the rupture, and at the same time, the microspheres release thrombin, forming a mechanical anchor by knotting the composite suture 100, and synchronously releasing thrombin to enhance hemostasis.

[0064] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A medical rapid hemostasis device, characterized by: A composite suture (100) is provided, wherein the composite suture (100) is used for performing a coagulation effect on a blood vessel; A sealing plug (200), wherein the sealing plug (200) can adaptively perform radial expansion and sealing; The anchoring device (400) is used to connect the composite suture (100) and the sealing plug (200), so that the sealing plug (200) is put on the composite suture (100) and pops out to the bevel of the blood vessel to complete the sealing of the blood vessel.

2. The medical rapid hemostasis device according to claim 1, characterized in that: The composite suture (100) includes a core layer (110), sodium alginate fibers (120) and thrombin-loaded PEG hydrogel microspheres (130), wherein the outer side of the core layer (110) is wrapped with the sodium alginate fibers (120), and the inner side of the sodium alginate fibers (120) is filled with the thrombin-loaded PEG hydrogel microspheres (130).

3. The medical rapid hemostasis device according to claim 2, characterized in that: The thrombin loading capacity of the PEG hydrogel microspheres (130) is 4000-6000 IU / cm, and the particle size distribution of the microspheres is 50-100 μm.

4. The medical rapid hemostasis device according to claim 3, characterized in that: The sealing plug (200) is composed of a shape memory alloy mesh (210) and a drug-loaded ePTFE layer (220), wherein the shape memory alloy mesh (210) is wrapped around the outside of the drug-loaded ePTFE layer (220), and guide grooves (230) are respectively provided on both sides of the outside of the shape memory alloy mesh (210), and a central channel (240) is also provided in the sealing plug (200).

5. The medical rapid hemostasis device according to claim 4, characterized in that: The expansion ratio of the shape memory alloy mesh (210) is 1:3, and the applied radial pressure is ≥80 kPa.

6. The medical rapid hemostasis device according to claim 5, characterized in that: The fibrinogen concentration in the thrombin-fibrinogen complex impregnated with the drug-loaded ePTFE layer (220) is 180-220 mg / cm 3 .

7. The medical rapid hemostasis device according to claim 6, characterized in that: The anchoring device (400) includes a detachable sleeve (410) and a snap spring assembly (420), wherein the snap spring assembly (420) is mounted on the upper and lower ends of one side of the sleeve (410), and the other end of the snap spring assembly (420) is detachably connected to the composite suture (100), so that after the connection, the sealing plug (200) and the composite suture (100) achieve a synergistic effect of mechanical anchoring and chemical hemostasis.

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