Efficient bleeding stopping suite for broken limbs

Abstract

The invention relates to a medical first-aid instrument. The efficient bleeding stopping suite for the broken limb comprises an anastomosis cylinder and connecting assemblies arranged at the two ends of the anastomosis cylinder and used for being combined with the broken end. The center of the anastomosis cylinder is provided with a funnel-shaped center cone which is gradually shrunk towards the telecentric end, and the telecentric end of the center cone and the anastomosis cylinder are coaxially provided with a center cylinder; the central cylinder is communicated with the central cone, and a control valve is arranged on the central cylinder; an anastomosis needle used for being inserted into a broken limb artery is further arranged at the distal end of the center cylinder. Targeted rapid hemostasis can be effectively achieved on the whole, stable temporary blood supply is efficiently constructed, and the replanting survival rate of the fractured limbs is remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application relates to medical first-aid devices, in particular to a high-efficiency amputation hemostasis kit. BACKGROUND

[0002] In the scenarios of industrial production, construction, traffic accidents and military operations, limb amputation injury is a high-incidence serious trauma, and its core harm is massive arterial bleeding within a short time after injury. If hemostasis is not timely or improper, it is easy to cause hemorrhagic shock, and even lead to death. At the same time, the blood supply of amputated limb (stump) is interrupted, which will quickly cause ischemia and hypoxia of the distal tissue, and cell necrosis, seriously affecting the success rate of subsequent amputation replantation surgery and reducing the effect of postoperative limb function recovery.

[0003] At present, the commonly used amputation hemostasis methods in clinic mainly include tourniquet compression hemostasis, gauze packing hemostasis and hemostatic forceps clamping hemostasis. Among them, tourniquet compression hemostasis is the mainstream way of on-site first aid, but it can only achieve temporary blockage of the proximal end artery and cannot solve the problem of continuous bleeding at the stump end. Long-time compression can easily lead to local tissue damage and vascular spasm, further aggravating the degree of stump ischemia; gauze packing hemostasis relies on the experience of the operator, and the hemostatic effect is unstable. Moreover, it is easy to adhere to the wound tissue, which may cause secondary injury during subsequent debridement; hemostatic forceps clamping hemostasis can precisely block the bleeding blood vessels, but the operation is difficult, and it is only suitable for professional medical staff to use in hospital scenarios, which cannot meet the rapid implementation needs of on-site first aid.

[0004] In addition, the existing hemostasis technology generally lacks temporary maintenance function for stump blood supply. The success of amputation replantation surgery is directly related to the ischemia tolerance time of stump tissue. Generally, if the limb ischemia exceeds 6-8 hours, the success rate of replantation will decrease significantly. The traditional hemostasis method only focuses on the single target of "hemostasis", and cannot establish temporary blood circulation at the stump end, resulting in continuous ischemia of the stump tissue during the waiting period for surgery. This not only increases the difficulty of replantation surgery, but also may lead to poor recovery of limb sensation and motor function after surgery, and even cause limb necrosis and require secondary amputation.

[0005] Therefore, there is an urgent need for an amputation hemostasis device with high-efficiency hemostasis and temporary blood supply maintenance function to solve the technical pain points of poor hemostasis effect and severe stump ischemic injury in the prior art, to provide more reliable support for on-site first aid and subsequent replantation surgery for amputation injury patients, and to improve the survival rate and limb function recovery quality of patients. SUMMARY

[0006] The purpose of the present application is to provide a high-efficiency amputation hemostasis kit which can improve the safety and efficiency of hemostasis and improve the activity of amputation replantation.

[0007] The technical scheme adopted by the present application is as follows: a high-efficiency amputation hemostasis kit, comprising an anastomosis cylinder and a connecting assembly arranged at both ends of the anastomosis cylinder and used for connecting with the amputation end; a center taper in the shape of a funnel is arranged in the center of the anastomosis cylinder and gradually narrows towards the distal end; a center cylinder is coaxially arranged at the distal end of the center taper; the center cylinder is in communication with the center taper, and a control valve is arranged on the center cylinder; and an anastomosis needle is arranged at the distal end of the center cylinder and used for being inserted into an artery of the amputation.

[0008] Preferably, the connecting assembly comprises a silica gel connecting sleeve, one end of the silica gel connecting sleeve is mounted on the peripheral surface of the end of the anastomosis cylinder, and the outer surface of the other end of the silica gel connecting sleeve is provided with a preliminary binding belt used for preliminarily binding the silica gel connecting sleeve on the amputation; and a ring-shaped sealing net capsule is further arranged on the inner surface of the end of the silica gel connecting sleeve away from the anastomosis cylinder, and the sealing net capsule is filled with water-absorbing and swelling filler.

[0009] Preferably, two groups of the sealing net capsules and the preliminary binding belts are arranged on the silica gel connecting sleeve at the proximal end of the anastomosis cylinder, and one group is arranged on the silica gel connecting sleeve at the distal end of the anastomosis cylinder.

[0010] Preferably, the water-absorbing and swelling filler is high water-absorbing resin particles.

[0011] Preferably, the preliminary binding belt is a hook-and-loop fastener, and a ring-shaped belt capsule or a plurality of belt buckles are arranged on the peripheral surface of the silica gel connecting sleeve and used for the hook-and-loop fastener to pass through.

[0012] Preferably, an annular arc top convex rib is arranged on the peripheral surface of the end of the anastomosis cylinder, one side of the arc top convex rib is provided with a ring-shaped bulging platform, an outer thread is arranged on the peripheral surface of the bulging platform, and a pushing sleeve threadedly matched with the bulging platform is externally fitted on the bulging platform; the silica gel connecting sleeve is sleeved and covers the arc top convex rib, and the end of the pushing sleeve is pressed on the arc top convex rib.

[0013] Preferably, the anastomosis needle comprises a spiral end cover matched with the center cylinder and a flexible needle body arranged on the spiral end cover, the flexible needle body gradually tapers from the root end to the overhanging end; an operation port and an operation cover matched with each other are arranged on the side wall of the anastomosis cylinder opposite to the flexible needle body, and a heparin cap used for inserting a syringe into the anastomosis cylinder and injecting anticoagulant into the anastomosis cylinder is further arranged on the operation cover.

[0014] Preferably, the operation end of the control valve extends to the outside of the anastomosis cylinder from one side of the anastomosis cylinder.

[0015] Preferably, the side wall of the center cone is provided with a plurality of strip-shaped backflow ports, the outer circumferential surface of the center cone is filled with filter filler between the inner circumferential surface of the anastomosis cylinder, the inner circumferential surface of the center cone is compounded with an elastic film, and the elastic film is provided with a plurality of backflow slits, the backflow slits and the backflow ports extend along the length direction of the conical surface of the center cone, and the backflow slits are distributed on the elastic film on both sides of the backflow ports.

[0016] Preferably, two side pipes are arranged on the side wall of the center cylinder at both ends of the control valve and are connected to the outside of the anastomosis cylinder; and a manual capsule pump is further included, the connecting pipes at both ends of the capsule body of the manual capsule pump are connected with the two side pipes respectively, and the connecting pipes are provided with on-off valves and one-way valves.

[0017] The beneficial effects of the present application are mainly reflected in: overall effective realization of targeted rapid hemostasis, efficient construction of stable temporary blood supply, and significant improvement of survival rate of replanted amputated limbs. Specifically, the core structure of the kit solves the technical contradiction that "rapid hemostasis" and "tissue blood supply maintenance" cannot be achieved at the same time in the traditional hemostasis mode through the innovative design of "valve closing rapid hemostasis + center cone pressure construction of temporary blood supply". The instant opening and closing function of the control valve greatly shortens the hemostasis time, avoids massive blood loss, and improves the efficiency of first aid; the tapering and pressurizing characteristics of the center cone cooperate with the stable anastomosis of the anastomosis needle to realize continuous and accurate construction of temporary blood supply, provide sufficient oxygen and nutrient supply for amputated limb tissue, avoid ischemic necrosis, and fundamentally improve the survival rate of replantation. The targeted puncture design can avoid the secondary damage of traditional hemostasis mode to blood vessels and nerves, the closed path cooperates with the anticoagulation system to prevent thrombus formation, the sealing protection and filter backflow design effectively reduce the risk of infection, and the whole set of device forms a "rapid hemostasis-temporary blood supply-anticoagulation and keep open-sealing protection" whole process solution, which not only meets the convenient operation needs of first aid scene, but also lays a good blood vessel and tissue foundation for replantation surgery, significantly improves the comprehensive effect of amputated limb first aid and replantation.

[0018] Working principle

[0019] When a limb amputation accident occurs, first use the traditional compression tourniquet to compress and bundle the proximal side, and then disinfect. First close the control valve, fix the proximal end of the amputated limb to the proximal end of the anastomosis cylinder through the connecting assembly (when using the connecting assembly, the amputated limb is inserted into the silicone connecting sleeve, and the preliminary tightening is performed with the pre-bundling belt. The water-absorbing expansion filler contacts the blood and quickly absorbs water to expand, driving the mesh capsule to expand radially towards the amputated limb blood vessel wall, and the radial pressure realizes the sealing and fitting of the amputated limb and the anastomosis cylinder to avoid blood leakage). Then release the compression tourniquet, and as the proximal arterial pressure is released, blood is injected into the anastomosis cylinder. Under the premise that the amount of bleeding is within a safe range, the blood in the anastomosis cylinder gradually fills and reaches pressure balance, realizing stable hemostasis. Then disinfect and remove the surface impurities of the isolated amputated limb, and fix it to the distal end of the anastomosis cylinder in the same way through the connecting assembly. During the fixing process, the anastomosis needle needs to be inserted into the arterial lumen of the isolated amputated limb (open the operation cover and operate through the operation port for higher efficiency; the anastomosis cylinder is made of transparent material, which is convenient for real-time observation of the operation process). Gradually open the control valve, and use the fluid mechanics effect to realize pressure when the blood flows through the tapered flow channel of the center cone. The blood is accurately injected into the arterial lumen of the isolated amputated limb through the anastomosis needle guided by the center cylinder, and a continuous and stable temporary blood supply is constructed to ensure the activity of the isolated amputated limb tissue. After the blood flows back through the veins of the isolated amputated limb, it enters the distal segment of the anastomosis cylinder (heparin can be injected through the heparin cap to prevent blood clotting and thrombus formation), and as the blood enters, the distal segment of the anastomosis cylinder is gradually filled with blood. This process is the first stage (passive blood supply stage), which constructs a temporary blood supply for the isolated amputated limb. If the first stage does not meet the surgical conditions or is still in the transportation process, a manual capsule pump can be connected and the control valve is closed. At this time, the temporary blood supply of the isolated amputated limb is actively constructed by squeezing the manual capsule pump, and this process is the second stage (active blood supply stage). In the second stage, the backflow port of the center cone and the backflow seam on the elastic membrane play a one-way guiding role, and cooperate with the filter filler to filter blood impurities and guide backflow, ensuring smooth blood supply. The inevitable bleeding phenomenon of the traditional compression tourniquet is effectively transformed into temporary blood supply for the isolated amputated limb, realizing efficient temporary storage and resource utilization of the bleeding blood. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 The structure of the present application is shown in the figure;

[0021] Figure 2 The internal structure of the anastomosis cylinder is shown in the figure;

[0022] Figure 3 The Figure 2 The A part of the figure is enlarged;

[0023] Figure 4 The Figure 2 The B part of the figure is enlarged;

[0024] Figure 5 For Figure 2 Structure diagram of the structure shown in the middle after being combined with a severed limb. DETAILED DESCRIPTION

[0025] Face combination Figures 1-5 To make a detailed and comprehensive description of the high-efficiency severed limb hemostasis kit of the present application, the present embodiment is only used to explain the present application and does not limit the protection scope of the present application. The present embodiment supplements multiple optional solutions, adaptation scene optimization and detail design on the basis structure to ensure the use requirements in different first-aid scenes. The structure, assembly relationship and optional implementation modes of each component are as follows:

[0026] I. Main structure and assembly

[0027] (I) Design of anastomosis cylinder 1

[0028] The anastomosis cylinder 1 is the bearing body of the complete set of devices, which is made of medical-grade ABS material, PC material or titanium alloy:

[0029] Medical-grade ABS material: integrally injection molded, length 8-12 cm, inner diameter 3-5 cm, wall thickness 0.8-1.2 cm, low cost and easy to mass produce, suitable for conventional first-aid scenes;

[0030] PC material: transparency ≥ 90%, can directly observe the severed end bleeding and blood vessel alignment, length 10-14 cm, inner diameter 3-6 cm, wall thickness 1.0-1.5 cm, stronger impact resistance, suitable for scenes requiring visual operation;

[0031] Titanium alloy material: machined, length 8-10 cm, inner diameter 3-4 cm, wall thickness 0.6-0.8 cm, light weight, high strength and excellent biocompatibility, suitable for special environments (such as battlefield, high altitude) or long-term temporary fixation scenes.

[0032] The anastomosis cylinder 1 is provided with an annular arc top rib 10 on the outer circumferential surface of both ends, the arc surface radius of the arc top rib 10 is 0.3-0.5 cm, and a bulging boss 11 is integrally formed on one side close to the end of the anastomosis cylinder 1. The outer circumferential surface of the bulging boss 11 is processed with fine tooth external thread (thread pitch 0.5-0.8 mm), and the outer diameter of the bulging boss 11 is 0.5-1.0 cm smaller than the maximum outer diameter of the arc top rib 10, forming a stepped structure to provide a compression support surface for the silicone connecting sleeve 7. In addition, the outer circumferential surface of the anastomosis cylinder 1 is also uniformly provided with 3-4 anti-slip protrusions (height 0.2-0.3 cm, spacing 3-4 cm) to facilitate the holding and operation of medical personnel and avoid hand slipping.

[0033] (II) Design of connecting assembly 2

[0034] The connection assembly 2 is used to realize the fixed sealing of the anastomosis cylinder 1 and the severed limb, and the core includes a silica gel connecting sleeve 7, a pre-binding belt 8, a sealing mesh bag 9, and an extrusion sleeve 12, each component provides multiple optional designs:

[0035] 1. The silica gel connecting sleeve 7:

[0036] Basic version: made of medical-grade soft silica gel, Shore hardness 30-40HA, thickness 0.5-0.8cm, length 5-8cm, smooth inner wall, suitable for conventional severed limbs of different thicknesses;

[0037] Thick version: thickness 1.0-1.2cm, Shore hardness 35-45HA, inner wall with annular anti-slip pattern (spacing 0.5cm, depth 0.1cm), suitable for scenarios where the severed limb skin is severely damaged or the fat layer is thick, improving the stability of the fixation;

[0038] Long version: length 10-15cm, Shore hardness 25-35HA, more flexible, suitable for scenarios where the end of the limb (such as fingers, toes) or the severed end is longer, can wrap more skin tissue, and the sealing effect is better.

[0039] 2. Pre-binding belt 8:

[0040] Scheme one: medical adhesive fastener, width 2-3cm, the silica gel connecting sleeve 7 has a ring of belt bags (inner diameter 2.5-3.5cm) integrally formed on the surface, the adhesive fastener passes through the belt bag to form a ring-shaped binding, the effective adhesive length of the adhesive fastener is 10-15cm, suitable for severed limbs with a diameter of 2-8cm;

[0041] Scheme two: elastic stretch band + buckle, the elastic stretch band has an elastic elongation rate of ≥150%, width 1.5-2cm, the end is provided with a plastic buckle (adjustable 3-5 levels), the silica gel connecting sleeve 7 is provided with 3-4 buckles on the surface, the elastic stretch band passes through the buckle and is fixed by the buckle, which is convenient for quickly adjusting the binding force and avoiding damage to the skin due to excessive tightness;

[0042] Scheme three: magic tape + elastic fabric band combination, the fabric band is made of medical polyester fiber, width 2cm, the magic tape has an adhesive strength of ≥5N / cm 2 , suitable for scenarios that need to be repeatedly disassembled and adjusted (such as checking the severed end during transportation).

[0043] Among them, two groups of pre-binding belts 8 (spacing 1-1.5cm) are arranged on the silica gel connecting sleeve 7 at the proximal end of the anastomosis cylinder 1, and one group of pre-binding belts 8 is arranged at the distal end; in the optional scheme, an additional elastic restraint belt (width 3cm, elastic elongation rate ≥200%) can be added at the proximal end to enhance the hemostatic effect at the proximal end, suitable for scenarios where arterial bleeding is more severe.

[0044] 3. Sealing mesh bag 9:

[0045] Basic version: annular medical nylon mesh bag (mesh aperture 0.1-0.3 cm), fixed on the inner surface of the silica gel connecting sleeve 7 away from the end of the anastomosis cylinder 1, 1-2 cm away from the end, filled with high water absorption resin particles (water absorption expansion ratio ≥300 times, particle size 0.1-0.2 cm) inside, which expands quickly to form a seal after absorbing leaked blood;

[0046] Enhanced version: the mesh bag is made of medical polyester fiber (tensile strength ≥10 N), and is mixed and filled with high water absorption resin particles and medical hemostatic cotton (mass ratio 3:1) inside. The hemostatic cotton can quickly absorb a large amount of blood, and the resin particles fill the gaps after expansion, suitable for scenes with large amount of bleeding;

[0047] Antibacterial version: a layer of silver ion antibacterial coating (coating thickness 0.01-0.02 cm) is coated on the surface of the high water absorption resin particles, with an antibacterial rate ≥99%, which can prevent infection of the cut end, and is suitable for scenes with complex emergency environment (such as outdoors, accident scene).

[0048] 4. Pushing sleeve 12:

[0049] Conventional version: annular structure, made of medical plastic, with internal threads on the inner wall matched with the external threads of the bulging boss 11, and an annular pressing surface (width 0.5-0.8 cm) at the end to press the edge of the silica gel connecting sleeve 7 when tightened;

[0050] Quick locking version: uses a quick release thread structure (thread pitch 1.5-2.0 mm), which can be quickly tightened or disassembled, and the outer wall is provided with 3-4 anti-slip ribs (height 0.3 cm) for easy operation with gloves;

[0051] Pressure display version: the end of the pushing sleeve 12 is provided with a pressure sensing sheet, and the outer peripheral surface is provided with an LED pressure indicating lamp (red, yellow, green three colors), which stops tightening when the pressing pressure reaches 0.1-0.2 MPa (green indicating lamp bright), to avoid damage to the silica gel connecting sleeve 7 due to excessive pressure.

[0052] II. Hemostasis and blood vessel protection structure

[0053] (I) Optimal design of central cone 3 and central cylinder 4

[0054] 1. Central cone 3:

[0055] Basic version: made of medical grade elastic plastic (Shore hardness 50-60 HA), integrally formed in the center of the anastomosis cylinder 1, funnel-shaped, with an inner diameter at the proximal end matched with the anastomosis cylinder 1 (3-5 cm), an inner diameter at the distal end of 0.8-1.2 cm, a cone angle of 30°-45°, and a smooth inner wall for easy blood flow;

[0056] Adjustable version: adopts multi-section splicing structure, composed of 3-4 fan-shaped elastic pieces, controls the cone angle (20°-50° adjustable) through the circumferentially arranged adjusting screws, adapts to different diameter amputated arteries, and improves the blood vessel alignment accuracy.

[0057] Antibacterial coating version: the inner circumferential surface is coated with a layer of medical antibacterial coating (such as polyhexamethylene guanidine hydrochloride coating), the coating thickness is 0.02-0.03 cm, the antibacterial rate is ≥99.5%, and the blood residue is avoided to breed bacteria.

[0058] The side wall of the center cone 3 is uniformly provided with 3-4 strip-shaped backflow openings 17 (length 3-5 cm, width 0.5-0.8 cm) extending along the length direction of the cone surface; in an optional scheme, a medical stainless steel filter screen (pore size 0.1 cm) can be arranged in the backflow opening 17 to further filter impurities in the blood.

[0059] 2. Center cylinder 4:

[0060] Material options: medical stainless steel (316L) or medical titanium alloy, the stainless steel version has lower cost, and the titanium alloy version has lighter weight and better biocompatibility;

[0061] Size adaptation: length 5-8 cm, outer diameter 0.8-1.2 cm, wall thickness 0.2-0.3 cm, far end extending to the outside of the anastomosis cylinder 1 by 1-2 cm, outer circumferential surface is processed with external threads (for mounting the anastomosis needle 6);

[0062] Reinforced version: the inner wall of the center cylinder 4 is provided with a wear-resistant coating (such as titanium nitride coating), the thickness is 0.01-0.02 cm, the service life is improved, and it is suitable for repeated use scenes (which need to be strictly sterilized).

[0063] (II) Multiple specifications of anastomosis needle 6

[0064] The anastomosis needle 6 is used for inserting into the amputated artery to achieve precise hemostasis and blood vessel protection, including a spiral end cover 13 and a flexible needle body 14, and multiple specifications and functional options are designed:

[0065] 1. Flexible needle body 14:

[0066] Specification one (regular version): medical silicone coated stainless steel needle core, diameter 0.3-0.5 cm, length 3-5 cm, root end diameter 0.5 cm, overhanging end diameter 0.1-0.2 cm, taper 1:10-1:15, suitable for adult extremity arteries;

[0067] Specification two (thin version): diameter 0.2-0.3 cm, length 2-3 cm, overhanging end diameter 0.08-0.1 cm, suitable for small arteries of children or extremities (such as fingers and toes);

[0068] Specification three (thick): diameter 0.5-0.7cm, length 4-6cm, overhanging end diameter 0.2-0.3cm, suitable for large arteries such as thigh, upper arm and other bleeding scene.

[0069] The outer layer of the flexible needle body 14 is made of silica gel with a Shore hardness of 25-35HA, and the surface is coated with a medical lubricating coating (such as a polytetrafluoroethylene coating) to reduce frictional damage to the blood vessel wall during insertion.

[0070] 2. Screwed end cap 13:

[0071] Made of medical plastic, the inner wall is processed with internal threads, which are matched with the external threads of the far end of the center cylinder 4, and after tightening, sealing and fixation are achieved; the inner wall of the end cap is provided with an annular silica gel sealing ring (thickness 0.2cm), which is pressed against the end face of the center cylinder 4 after tightening, improving the sealing effect and preventing blood leakage.

[0072] 3. Operation port 15 and operation cover 16:

[0073] Operation port 15: opened on the side wall opposite to the flexible needle body 14 of the anastomosis cylinder 1, with a diameter of 2-3cm, and an annular step (width 0.3cm) is arranged on the edge for placing the operation cover 16;

[0074] Operation cover 16:

[0075] Transparent version: made of medical PC material with a transparency of ≥90%, connected to the anastomosis cylinder 1 through a hinge, and fixed by buckling after closing, which is convenient for observing the internal operation;

[0076] Removable version: adopts a threaded connection method, the outer periphery of the operation cover 16 is processed with external threads, and the inner wall of the operation port 15 is processed with internal threads, which are tightly fixed after closing, with better sealing performance;

[0077] Multifunctional version: in addition to the heparin cap, a small pressure monitoring interface is added on the operation cover 16, which can be connected to a pressure sensor to monitor the blood pressure in the anastomosis cylinder 1 in real time, providing data support for first aid.

[0078] (Three) Selection and design of control valve 5

[0079] The control valve 5 is used to control the on-off of the center cylinder 4, and two optional types are provided:

[0080] Scheme one: medical ball valve, the valve body is made of medical stainless steel, the valve core is made of PTFE material, the operation end extends to the outside of the anastomosis cylinder 1 by 1-1.5cm, and an anti-slip knob (diameter 1.5cm) is arranged at the end, which can realize on-off by rotating 90°, with simple operation;

[0081] Scheme two: medical stop valve, using threaded adjustment structure, the operating end is provided with scale mark (0-5 scale), which can realize flow fine adjustment and is suitable for scenes needing to control blood flow rate (such as when the blood circulation of the distal end of amputated limb is weak).

[0082] The valves of the two schemes have good sealing performance, and the leakage is ≤0.1 ml / min in the closed state, and the operating end is provided with anti-slip design, which is convenient for gloved operation.

[0083] Three, backflow and circulation auxiliary structure

[0084] (I) backflow port 17 and elastic film 19

[0085] 1. Backflow port 17: In addition to the basic strip design, a “strip + circle” combined structure can also be used, that is, 3-4 strip-shaped backflow ports 17 (length 3-5 cm, width 0.5-0.8 cm) are arranged on the side wall of the center cone 3, and 4-6 circular backflow holes (diameter 0.3-0.5 cm) are uniformly arranged between the strip-shaped backflow ports 17, which further improves the backflow efficiency; The edges of the backflow port 17 are chamfered (fillet radius 0.1 cm) to avoid scratching the elastic film 19.

[0086] 2. Elastic film 19:

[0087] Basic version: medical polyurethane elastic film, thickness 0.1-0.2 cm, elongation at break ≥300%, backflow seam 20 is closed in a natural state, when the blood pressure in the anastomosis cylinder 1 reaches 0.05-0.1 MPa, the elastic film 19 expands to open the backflow seam 20 (opening degree 0.1-0.3 cm);

[0088] Adjustable version: The edge of the elastic film 19 is provided with an annular adjusting ring, the pre-tightening force of the elastic film 19 can be changed through the adjusting ring, and then the opening pressure (0.03-0.15 MPa adjustable) of the backflow seam 20 is adjusted to adapt to different bleeding conditions;

[0089] The backflow seam 20 extends along the length direction of the taper surface of the center cone 3, and the length is matched with the backflow port 17, and the edge of the backflow seam 20 is heat-sealed to prevent tearing.

[0090] (II) Filter filler 18

[0091] The filter filler 18 is used to filter impurities such as tissue debris in the blood, and three optional materials are provided:

[0092] Scheme one: medical sterile absorbent cotton, thickness 1-1.5 cm, fiber length 2-3 cm, filtration accuracy ≥50 μm, good adsorption performance, which can adsorb impurities and part of coagulation factors in blood;

[0093] Scheme two: medical filter sponge, material is polyurethane sponge, porosity is 80-90%, thickness is 1.5-2cm, filtering accuracy is greater than or equal to 30μm, air permeability is good, and it has certain elasticity, so that blockage caused by extrusion can be avoided;

[0094] Scheme three: medical stainless steel filter screen + absorbent cotton combination, the filter screen is made of 304 stainless steel, the aperture is 0.05cm, is arranged outside the reflux port 17, and the absorbent cotton is filled between the filter screen and the inner wall of the anastomosis cylinder 1, so that the filtering effect is better, and it is suitable for scenes where the damaged end tissue is seriously damaged and there are more impurities.

[0095] The filter filler 18 is designed to be detachable, a filler replacement opening (2cm in diameter) is formed in the side wall of the anastomosis cylinder 1, and the opening is sealed by a sealing cover, so that the contaminated filter filler can be replaced during first aid.

[0096] (Three) manual bag pump 22

[0097] The manual bag pump 22 is used to provide temporary blood circulation for the distal end of the severed limb, and includes a bag 23, a connecting pipe 24, an on-off valve 25 and a one-way valve 26, and multiple optimization schemes are designed.

[0098] 1. Bag 23:

[0099] The medical natural rubber bag has a volume of 50-100ml, a wall thickness of 0.3-0.5cm, an elastic recovery rate of greater than or equal to 90%, and can quickly rebound after extrusion; the large-capacity version has a volume of 150-200ml, and is suitable for scenes where the severed limb is longer and more circulating blood is needed; the pressure regulating version: the outer peripheral surface of the bag 23 is provided with a pressure scale (0.05-0.3MPa), and the inside is provided with a pressure limiting valve, which automatically releases pressure when the extrusion pressure exceeds 0.3MPa, so as to avoid damage to blood vessels due to excessive pressure.

[0100] 2. Connecting pipe 24 and valve:

[0101] Connecting pipe 24: medical PVC pipe or silica gel pipe, inner diameter 0.3-0.5cm, length 20-30cm, pipe wall thickness 0.1-0.2cm, pressure resistance greater than or equal to 0.5MPa, bendable angle greater than or equal to 180°, convenient to place during transportation;

[0102] On-off valve 25: a medical stop valve is used, and the operation end is provided with obvious “on / off” marks, so as to quickly identify the valve state;

[0103] One-way valve 26: medical ball valve type one-way valve or diaphragm type one-way valve can be selected, forward flow resistance is less than or equal to 0.02MPa, reverse leakage is less than or equal to 0.05ml / min, to ensure one-way blood flow (proximal end side pipe 21→bag 23→distal end side pipe 21).

[0104] 3. Alternative scheme: electric micro pump:

[0105] For the scene of limited physical strength of first aid personnel or long time transfer, the manual capsule pump 22 can be replaced by an electric micro pump. The pump body is made of medical plastic, the weight is ≤200g, the power supply is lithium battery (continuous running time ≥4 hours), the pump speed can be adjusted (30-60 times / minute), and the pump speed can be adjusted (30-60 times / minute). The frequency of the simulated heart beat is provided to provide stable blood circulation support for the distal end of the severed limb; the control panel of the electric micro pump is provided with a one-key start button and a speed adjusting knob, which is easy to operate.

[0106] Four, auxiliary function components

[0107] In order to improve the practicability and safety of the whole device, the following auxiliary function components are added:

[0108] 1. Hemostatic cotton storage cavity: an annular storage cavity (depth 1-1.5 cm, width 2 cm) is formed on the outer surface of the anastomosis cylinder 1, and a sterile hemostatic cotton is placed inside. The storage cavity is sealed by a sealing cover, and the hemostatic cotton can be taken out during first aid to assist hemostasis around the cut end.

[0109] 2. Disinfecting cotton piece fixing groove: 2-3 fixing grooves (depth 0.5 cm, width 1 cm) are arranged on the outer surface of the silica gel connecting sleeve 7, which can place alcohol disinfecting cotton pieces, which are used for temporary disinfection of the skin of the severed limb to reduce the risk of infection.

[0110] 3. Suspension ring: two suspension rings (diameter 1 cm) are symmetrically arranged on the outer surface of the anastomosis cylinder 1, which can be penetrated by a rope or a hook, so that the whole device can be fixed during transfer to avoid displacement of the anastomosis needle 6 caused by shaking.

[0111] 4. Identification scale: a length scale (accuracy 1 cm) is arranged on the outer surface of the anastomosis cylinder 1, and a diameter scale (accuracy 0.5 cm) is arranged on the outer surface of the silica gel connecting sleeve 7, which is convenient for medical staff to quickly judge the size of the severed limb and the installation position of the device.

[0112] Five, some common use methods (multi-scene adaptation)

[0113] (I) Common scene use steps

[0114] 1. When the severed limb is first aid, the cut end is simply cleaned, and obvious tissue debris and foreign matter are removed;

[0115] 2. Select the appropriate size of the silica gel connecting sleeve 7 and the anastomosis needle 6, and set the silica gel connecting sleeve 7 at the proximal end of the anastomosis cylinder 1 on the proximal end of the severed limb, and preliminarily fix it through the two groups of pre-bundling belts 8, so that the cut end is aligned with the center cone 3;

[0116] 3. Open the operation cover 16, slowly insert the flexible needle body 14 of the anastomosis needle 6 into the severed limb artery, tighten the screw end cover 13, inject an appropriate amount of anticoagulant (such as heparin sodium, the dosage is adjusted according to body weight) through the heparin cap, and close the operation cover 16;

[0117] 4. Put the silicone connecting sleeve 7 at the distal end of the anastomosis cylinder 1 on the distal end of the severed limb, fix it with the pre-bundling belt 8, and after the filler in the sealing mesh capsule absorbs the leaked blood and expands, a preliminary seal is formed;

[0118] 5. Tighten the extrusion sleeve 12 at both ends to further compress the silicone connecting sleeve 7 and ensure the sealing effect, open the control valve 5, and observe the bleeding situation. If there is a lot of bleeding, the elastic restraint belt at the proximal end can be used to enhance hemostasis;

[0119] 6. Connect the connecting pipe 24 of the manual capsule pump 22 to the side pipe 21, open the on-off valve 25, and provide temporary circulation to the distal end of the severed limb by extruding the capsule body 23 (frequency 40-50 times / min);

[0120] 7. After transportation to the hospital, subsequent vascular anastomosis operations can be performed through the operation port 15 without disassembling the entire set of devices. If the filter needs to be replaced, the filter replacement port can be opened for replacement.

[0121] (II) Special scene adaptation steps

[0122] 1. Severed limb at the end of the extremity (such as a finger):

[0123] Choose a thin anastomosis needle 6, a long silicone connecting sleeve 7, and an elastic stretchy belt + buckle type pre-bundling belt 8;

[0124] After the silicone connecting sleeve 7 is fitted, the bundling force is adjusted by the buckle to avoid being too tight and affecting blood circulation;

[0125] Use a small capacity manual capsule pump 22 (50ml) with an extrusion frequency of 50-60 times / min to provide gentle circulation support.

[0126] 2. Heavy bleeding scene:

[0127] Choose a thick silicone connecting sleeve 7, an enhanced sealing mesh capsule 9, and a thick anastomosis needle 6;

[0128] After injecting the anticoagulant, close the control valve 5, and slowly open the valve after the bleeding at the severed end is reduced;

[0129] Use a pressure-regulated capsule body 23 to control the extrusion pressure at 0.1-0.2MPa to avoid excessive pressure causing blood vessel damage.

[0130] 3. Long-time transportation scene:

[0131] Replace the electric micro pump, set the pump speed to 30-40 times per minute, and ensure stable circulation;

[0132] Periodically observe the broken end through the operation cover 16, and supplement the anticoagulant and replace the filter material if necessary;

[0133] Use the suspension ring fixing device to avoid shaking during transportation.

[0134] In addition, an emptying port can be provided on the side wall of the anastomosis cylinder 1 for air exhaust.

[0135] The high-efficiency amputation hemostasis kit of the embodiment realizes the integrated design of "fixing-sealing-hemostasis-circulation-protection" through multi-material selection, multi-specification adaptation, multi-function expansion and multi-scene optimization, solves the problems of poor hemostasis effect, easy blood vessel damage, insufficient adaptability and lack of temporary circulation support in traditional amputation first aid, is easy to operate, reliable in sealing, wide in adaptability, can effectively improve the success rate of amputation replantation, and is suitable for various scenes such as hospital first aid, battlefield rescue, field exploration and traffic accidents.

Claims

1. A high-efficiency limb amputation hemostasis kit, characterized in that: It includes an anastomosis tube (1) and connecting components (2) disposed at both ends of the anastomosis tube (1) for connecting with the severed ends; the anastomosis tube (1) has a funnel-shaped central cone (3) that gradually narrows toward the distal end, and a central tube (4) is coaxially disposed at the distal end of the central cone (3) and the anastomosis tube (1); the central tube (4) is connected to the central cone (3), and a control valve (5) is disposed on the central tube (4); the distal end of the central tube (4) is also provided with an anastomosis needle (6) for inserting into the artery of the severed limb.

2. The high-efficiency limb amputation hemostasis kit according to claim 1, characterized in that: The connecting assembly (2) includes a silicone connecting sleeve (7), one end of which is installed on the circumferential surface of the end of the anastomosis tube (1), and the outer surface of the other end is provided with a pre-binding strap (8) for initially binding the silicone connecting sleeve (7) to the amputated limb; the inner surface of the end of the silicone connecting sleeve (7) away from the anastomosis tube (1) is also provided with a ring-shaped sealing mesh (9), and the sealing mesh (9) is filled with water-absorbing and expanding filler.

3. The high-efficiency limb amputation hemostasis kit according to claim 2, characterized in that: The sealing mesh (9) and the pre-binding strap (8) are provided in two sets on the silicone connecting sleeve (7) at the proximal end of the anastomosis tube (1) and in one set on the silicone connecting sleeve (7) at the distal end.

4. The high-efficiency limb amputation hemostasis kit according to claim 2, characterized in that: The water-absorbing and expanding filler is composed of highly absorbent resin particles.

5. The high-efficiency limb amputation hemostasis kit according to claim 2, characterized in that: The pre-binding strap (8) is a hook and loop fastener, and the silicone connecting sleeve (7) has a loop of straps or multiple buckles on its circumference for the hook and loop fastener to pass through.

6. The high-efficiency limb amputation hemostasis kit according to claim 2, characterized in that: The annular arc-shaped protrusion (10) is provided on the circumferential surface of the end of the anastomosis cylinder (1). A ring of bulging protrusions (11) is provided on one side of the arc-shaped protrusion (10). The circumferential surface of the bulging protrusions (11) is provided with external threads, and the bulging protrusions (11) are fitted with a push sleeve (12) that forms a threaded engagement with the bulging protrusions (11). The silicone connecting sleeve (7) is fitted over the arc-shaped protrusions (10) and pressed against the arc-shaped protrusions (10) by the end of the push sleeve (12).

7. The high-efficiency limb amputation hemostasis kit according to claim 1, characterized in that: The anastomosis needle (6) includes a spiral end cap (13) adapted to the central cylinder (4) and a flexible needle body (14) disposed on the spiral end cap (13). The flexible needle body (14) gradually tapers from the root end to the overhang end. The anastomosis cylinder (1) is provided with an operating port (15) and an operating cover (16) on the side wall opposite to the flexible needle body (14). The operating cover (16) is also provided with a heparin cap for inserting a syringe and injecting an anticoagulant into the anastomosis cylinder (1).

8. The high-efficiency limb amputation hemostasis kit according to claim 1, characterized in that: The operating end of the control valve (5) extends from one side of the anastomosis tube (1) to the outside of the anastomosis tube (1).

9. The high-efficiency limb amputation hemostasis kit according to claim 1, characterized in that: The sidewall of the central cone (3) is provided with several strip-shaped reflux ports (17). The outer circumferential surface of the central cone (3) and the inner circumferential surface of the anastomosis cylinder (1) are filled with filter packing (18). An elastic membrane (19) is laminated on the inner circumferential surface of the central cone (3). Several reflux slits (20) are provided on the elastic membrane (19). The reflux slits (20) and reflux ports (17) extend along the length direction of the cone surface of the central cone (3), and the reflux slits (20) are distributed at intervals on the elastic membrane (19) on both sides of the reflux ports (17).

10. The high-efficiency limb amputation hemostasis kit according to claim 9, characterized in that: Two side tubes (21) connected to the outside of the anastomosis tube (1) are provided on the side wall of the central cylinder (4) located at both ends of the control valve (5); it also includes a manual bladder pump (22), the connecting pipes (24) at both ends of the bladder body (23) of the manual bladder pump (22) are respectively connected to the two side tubes (21), and the connecting pipes (24) are provided with an opening and closing valve (25) and a one-way valve (26).

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