Anti-drop ligation ring for promoting blood coagulation

Abstract

The invention discloses an anti-dropout ligation ring for promoting blood coagulation, and belongs to the field of medical devices. The ligation ring has two layers, an inner layer and an outer layer, and is made of biocompatible materials. The tail end of the ligation ring has a hollow gap, and the inner diameter is slightly larger than the head end. The inner layer is a degradable layer, and a variety of drug components are evenly dispersed, which can resist inflammation, promote blood coagulation, and inhibit angiogenesis. The near hemorrhoid side is designed with a unique anti-slip structure, and the outer layer is an elastic layer, with an anti-slip contraction groove inside, and an antibacterial drug coating is coated on the outer surface. The ligation ring of the present invention can promote the formation of blood coagulation in the ligated tissue after tissue ligation, inhibit angiogenesis, thereby accelerating the necrosis and shedding of the ligated tissue, and can also prevent the ligation ring from shifting, reduce the risk of the ligation ring loosening, and improve the stability of the ligation, which provides a safe, fast and convenient ligation method for tissue ligation.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to an anti-detachment ligation ring for promoting blood coagulation. Background Art

[0002] Hemorrhoids are the most common anal disease in clinical practice. There are a lot of literatures on hemorrhoids in traditional Chinese medicine. In 1975, the British Thomson proposed the modern concept of hemorrhoids: hemorrhoids are pathological hypertrophy of the anal cushions at the lower end of the rectum. According to the different locations of occurrence, hemorrhoids can be divided into internal hemorrhoids, external hemorrhoids and mixed hemorrhoids. Hemorrhoid attacks can cause patients to have blood in their stools, blood dripping, hemorrhoid prolapse, even mucosal erosion, exposed small blood vessels, anal fissures and other problems.

[0003] Ligating ring is an important method for hemorrhoid ligation. Its basic function is to transfer and fix the ligating ring at the surgical ligation position. In actual use, the ligating ring needs to be manually opened, and then put on the adsorption tube mouth at the front end of the ligating device, and finally the operation is completed. In recent years, people have carried out many meaningful explorations in the development of ligating rings.

[0004] Patent 2022108524033 discloses a drug coating for a ligation device and a preparation method thereof, wherein the drug coating includes sodium carboxymethyl cellulose, alginate, chitosan, an anti-inflammatory analgesic, polyvinyl alcohol, and distilled water; the microspheres or drugs are firmly adhered to the surface of the coating by a cyanoacrylate curing process, and chitosan can quickly release the drug when it comes into contact with water, and its own cationicity can promote coagulation. At the same time, anti-inflammatory and analgesic drug ingredients are added to the drug coating to prevent infection and promote healing. However, the method of combining the drug coating with the ligation ring is not described in detail, and there are problems that the drug coating is easy to fall off and the onset time is short.

[0005] Patent 2022106304683 discloses a ligature body that can continuously squeeze tissue, including a base body with a through inner ring, and a continuous squeezing material is arranged on the inner side of the inner ring. The continuous squeezing material arranged on the base body can give continuous compression force to the hemorrhoid tissue, promoting the complete ischemia and necrosis of the hemorrhoid tissue and its shedding. However, there are still problems such as easy infection after ligation and easy shedding of the ligature ring.

[0006] In summary, since the diameter of the ligature ring is very small after it shrinks in its natural state (generally less than 2 mm), there are problems such as the ligature ring is easy to fall off, cannot continue to shrink inward, resulting in incomplete ligation, the ligated tissue cannot be completely necrotic and fall off due to insufficient locking force of the ligature ring, the function is single, and the ligature site is prone to inflammatory reactions. Summary of the invention

[0007] The purpose of the present application is to provide a coagulation-promoting anti-detachment ligature ring, which can promote coagulation in the ligated tissue and inhibit angiogenesis after tissue ligation, thereby accelerating necrosis and detachment of the ligated tissue, and can also prevent the ligature ring from shifting, reduce the risk of the ligature ring loosening, and improve the beneficial effect of ligation stability.

[0008] To achieve the above-mentioned effects, the ligation ring proposed in the present application consists of an inner and outer layer, which are made of biocompatible materials. The inner diameter of the tail end of the ligation ring is slightly larger than that of the head end, and there is a hollow gap at the tail end, which can control the ligation tissue at the tail end of the ligation ring or overflow at the hollow gap position; the inner layer is a degradable layer, forming a multi-chamber structure from the inside to the outside, and a variety of drug components are evenly dispersed inside. According to the ligation cycle, it exerts anti-inflammatory, promotes coagulation, and inhibits angiogenesis functions. A unique anti-slip structure is designed on the near-hemorrhoidal side, and the elastic layer of the ligation ring has an anti-slip contraction groove inside, and the outer surface is coated with an antibacterial drug coating.

[0009] Furthermore, the ligation ring is made of biocompatible materials, which will not cause obvious adverse reactions in the human body after ligating the tissue, and the performance of the material itself will not change excessively due to the internal environment of the human body. The outer diameter is 4-6mm, the inner diameter of the head end is 0.5-3mm, the inner diameter of the tail end is 0.8-3mm, the thickness is 1-5mm, and the length is 2-10mm. The appropriate ligation ring can be selected according to the ligated tissue of the patient.

[0010] Furthermore, the inner layer of the ligation ring is a degradable layer, which is made of a degradable biocompatible material. This material is one or more combinations of polylactic acid polymer materials, polyglycolic acid polymer materials, and polycaprolactone polymer materials. The degradable material of the inner layer can gradually degrade after the tissue is ligated, which not only provides a certain support force to ensure the effect in the early stage of ligation, but also reduces the continuous compression of the ligation ring on the tissue in the later stage of ligation, thereby avoiding ischemic necrosis of normal tissue due to long-term compression.

[0011] Furthermore, the outer layer of the ligation ring is an elastic layer, which is made of an elastic biocompatible material, which is one or more combinations of silicone rubber, polyurethane, and polyetheretherketone. Due to its elastic recovery characteristics, the ligation ring can closely fit the hemorrhoidal tissue after being released to prevent loosening from the tissue during the ligation process.

[0012] Furthermore, the ligation ring is designed with a unique anti-slip structure on the hemorrhoid side, which is one of a wave pattern, a hemispherical protrusion or an inner tooth structure. The anti-slip structure increases the friction between the ligation ring and the tissue, reduces the possibility of the ligation ring loosening and falling off, and ensures the continuous effectiveness of the ligation effect.

[0013] Furthermore, the elastic layer has a reserved coaxial channel along its central axis as a contraction groove, which maintains a coaxial relationship with the outer contour of the ligation ring in space, and the two ends of the contraction groove extend to the outer surface of the elastic layer respectively. The contraction groove has a diameter of 0.1-2 mm and a number of 1-6. A tightening line or a U-shaped buckle is placed, wherein the contraction line is a nylon line or a polypropylene line. Before ligation, the tightening line is passed through the contraction groove. When the ligation ring is put on the hemorrhoid tissue, the tightening line is knotted, or the open end of the U-shaped buckle is stretched open to insert it into the contraction groove, and then the U-shaped buckle is restored to its original state, which can reduce the inner diameter of the ligation ring and achieve stable ligation of the tissue.

[0014] Furthermore, the drug content of the degradable layer is 1-100 μg / mL, and the drug component is a combination of one or more of hemostatic drugs, anti-inflammatory drugs, healing drugs, and drugs that inhibit angiogenesis.

[0015] Furthermore, there are 2-6 hollow gaps at the tail end of the ligation ring, with a length of 0.5-6 mm and a width of 1-3 mm. The tissue after ligation overflows at the hollow gap position, which can effectively prevent the ligation ring from slipping off.

[0016] Furthermore, the outer surface of the ligation ring is coated with an antibacterial coating by dipping in an antibacterial solution. The antibacterial coating is one of a silver ion coating, a copper ion coating, a chlorhexidine coating, and a quaternary ammonium salt coating. The concentration of the antibacterial solution is 1%-10%.

[0017] Furthermore, the ligation ring is made by flat plate molding, and its process flow is: charging, solution casting or injection molding, demoulding, preparing drugs, adding drugs to a multi-chamber structure, packaging, and sterilization.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The ligation ring consists of two layers, an inner layer and an outer layer, with an anti-slip design on the hemorrhoid-proximal side, and a hollow gap at the tail end with an inner diameter larger than the head end, thereby increasing the friction between the ligation ring and the tissue, and securing the ligated tissue at the tail end of the ligation ring or overflowing from the hollow gap, where it is pulled by the overflow force, thereby reducing the possibility of the ligation ring loosening and falling off, thereby ensuring that the ligation effect is sustained and effective.

[0020] (2) The inner layer of the ligature ring is made of a degradable polymer material. It can gradually degrade after ligation, providing a certain support force in the early stage to ensure the ligation effect, and gradually degrade in the later stage to reduce the continuous pressure of the ligature ring on the tissue, thus avoiding ischemic necrosis of normal tissue due to long-term pressure.

[0021] (3) A coaxial shrinkage groove is designed inside the outer elastic layer of the ligature ring, which cooperates with the tightening wire or U-shaped buckle to fix the ligature ring and ensure a continuous and stable ligature effect.

[0022] (4) The degradable layer of the ligature ring is designed with a multi-chamber structure, which can release hemostatic and anti-inflammatory drugs, healing drugs, and anti-angiogenesis drugs in a targeted manner according to the treatment stage, accelerate the shedding of the ligated tissue, reduce the side effects of one-time large-scale medication, and improve drug utilization and accuracy. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0024] Figure 1 This is a schematic diagram of the ligature ring;

[0025] Figure 2 This is a schematic diagram comparing the cross-sections of the head and tail ends of the ligature ring;

[0026] Figure 3 is a schematic diagram of the shrinkage groove in the elastic layer;

[0027] Figure 4 Schematic diagram of the multi-chamber structure in the degradable layer.

[0028] Figure numerals: 1 - degradable layer; 2 - elastic layer; 3 - shrinkage groove; 4 - hollow gap. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are 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 creative work are within the scope of protection of the present invention.

[0030] Combine the following Figure 1 , Figure 2 , Figure 3 and Figure 4The specific implementation mode of the present invention is further described. The anti-drop ligation ring for promoting coagulation of the present invention has two layers, an inner layer and an outer layer, and is made of a biocompatible material. The inner diameter of the tail end of the ligation ring is slightly larger than that of the head end, and the tail end has a hollow gap 4, which can control the ligation tissue at the tail end of the ligation ring or overflow at the hollow gap 4; the inner layer is a degradable layer 1, which is designed from the inside to the outside to form a multi-chamber structure, and a variety of drug components are evenly dispersed inside. According to the ligation cycle, it exerts anti-inflammatory, promotes coagulation, and inhibits angiogenesis functions. A unique anti-slip structure is designed near the hemorrhoid side, and the outer layer is an elastic layer 2 with a contraction groove 3 inside, and the outer surface is coated with an antibacterial drug coating.

[0031] The ligation ring is made by flat plate molding, and its process flow is: charging, solution casting or injection molding, demoulding, preparing drugs, adding drugs to a multi-chamber structure, packaging, and sterilization.

[0032] Example 1

[0033] In this embodiment, the degradable layer 1 of the ligation ring is made of polylactic acid, the elastic layer 2 is made of silicone rubber, with an outer diameter of 4 mm, an inner diameter of 0.5 mm at the head end, an inner diameter of 0.8 mm at the tail end, a length of 3 mm, 5 hollow gaps 4 at the tail end, and a shrinkage groove 3 inside the elastic layer 2 with a diameter of 0.4 mm and 1 in number.

[0034] A wavy pattern is designed on the hemorrhoid-proximal side of the degradable layer 2, and the internal multi-chamber structure consists of three layers, namely, the first chamber, the second chamber, and the third chamber from the surface close to the ligated tissue outward. The drug ingredients in the first chamber are thrombin and dexamethasone in a ratio of 2:1, the drug ingredients in the second chamber are dexamethasone and fibroblast growth factor in a ratio of 2:1, and the drug ingredients in the third chamber are dexamethasone and fibroblast growth factor in a ratio of 1:2.

[0035] The outer surface of the ligation ring is coated with a silver ion antibacterial coating.

[0036] The ligation ring is made by flat plate molding, and its process flow is: charging, solution casting or injection molding, demoulding, preparing drugs, adding drugs to a multi-chamber structure, packaging, and sterilization.

[0037] Example 2

[0038] In this embodiment, the degradable layer 1 of the ligation ring is made of polyglycolic acid, and the elastic layer 2 is made of polyurethane, with an outer diameter of 5 mm, an inner diameter of 0.8 mm at the head end, an inner diameter of 1 mm at the tail end, a length of 4 mm, and 4 hollow gaps 4 at the tail end. The diameter of the shrinkage groove 3 inside the elastic layer 2 is 0.3 mm and the number is 2.

[0039] A hemispherical protrusion is designed on the hemorrhoid side of the degradable layer 2, and the internal multi-chamber structure consists of three layers. From the surface close to the ligated tissue to the outside, there are the first chamber, the second chamber and the third chamber. The drug ingredients in the first chamber are tranexamic acid and dexamethasone in a ratio of 3:2, the drug ingredients in the second chamber are dexamethasone and epidermal growth factor in a ratio of 2:1, and the drug ingredients in the third chamber are dexamethasone and epidermal growth factor in a ratio of 2:3.

[0040] The outer surface of the ligation ring is coated with a copper ion antibacterial coating.

[0041] The ligation ring is made by flat plate molding, and its process flow is: charging, solution casting or injection molding, demoulding, preparing drugs, adding drugs to a multi-chamber structure, packaging, and sterilization.

[0042] Comparative Example

[0043] In this embodiment, ligation rings sold on the market were collected. The ligation rings were made of silicone rubber with an outer diameter of 4 mm, an inner diameter of 1.5 mm, and a thickness of 3.5 mm.

[0044] Test Example 1

[0045] In order to verify the ligation effect of the anti-dropout ligation ring for promoting blood coagulation of the present invention, Example 1 and Example 2 were taken respectively and numbered 1, 2, 3, 4, 5 and 6 in sequence; 3 sets of comparative ligation rings were taken and numbered 7, 8 and 9; the breaking force of the ligation ring was tested by a universal tensile testing machine (the ligation ring was cut open along the side wall and a tensile force was applied along the axial direction of the ligation ring). The test results are shown in Table 1.

[0046] Table 1 Record of ligature ring breaking force

[0047]

[0048] It can be seen from the above table that the breaking force of the ligation rings in the embodiments is all above 40N, which is significantly higher than that of the ligation rings in the comparative examples.

[0049] Test Example 2

[0050] In order to verify the ligation effect of the anti-detachment ligation ring for promoting blood coagulation of the present invention, 3 sets of ligation rings of Example 1 and Example 2 were taken respectively, and numbered 1, 2, 3, 4, 5, and 6 in sequence; 3 sets of ligation rings of the comparative example were taken, and numbered 7, 8, and 9; tissue ligation was performed on the anus of 3 test pigs respectively, and the time when the ligated tissue fell off and the inflammation at the ligated tissue were recorded. The test results are shown in Table 2.

[0051] Table 2 Record of the effect of the ligature test

[0052]

[0053] It can be seen from the above table that the ligature ring of the present invention can accelerate the shedding of the ligated tissue and reduce the probability of inflammation at the ligated position during the ligature period.

Claims

1. A blood coagulation-promoting anti-drop ligation ring, characterized in that: The ligation ring is composed of an inner and outer layer, and is made of a biocompatible material. The inner diameter of the tail end of the ligation ring is slightly larger than that of the head end, and there is a hollow gap at the tail end, so that the ligation tissue can be controlled at the tail end of the ligation ring or overflow at the hollow gap position; the inner layer is a degradable layer, and a multi-chamber structure is designed from the inside to the outside, and a variety of drug components are evenly dispersed inside, which can play the functions of hemostasis and anti-inflammation, promoting coagulation, and inhibiting angiogenesis according to the ligation cycle, and an anti-slip structure is designed on the near hemorrhoid side; the outer layer is an elastic layer, and there is a reserved coaxial channel inside along the central axis direction as a contraction groove, which maintains a coaxial relationship with the outer contour of the ligation ring in space, and the two ends of the contraction groove extend to the outer surface of the elastic layer respectively, the diameter of the contraction groove is 0.1-2mm, the number is 1-6, and a tightening line or a U-shaped buckle is placed, wherein the tightening line is a nylon line or a polypropylene line, and the outer surface is coated with an antibacterial drug coating.

2. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The outer diameter of the ligature ring is 4-6mm, the inner diameter of the head end is 0.5-3mm, the inner diameter of the tail end is 0.8-3mm, the thickness is 1-5mm, and the length is 2-10mm.

3. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The degradable layer of the ligature ring is made of a degradable biocompatible material, which is a combination of one or more of polylactic acid polymer materials, polyglycolic acid polymer materials, and polycaprolactone polymer materials. The elastic layer of the ligature ring is made of an elastic biocompatible material, which is a combination of one or more of silicone rubber, polyurethane, and polyetheretherketone.

4. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The anti-slip structure is one of a wave pattern, a hemispherical protrusion or an inner tooth structure.

5. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The drug content of the multi-chamber structure is 1-100 μg / mL, and the drug components are a combination of one or more of hemostatic drugs, anti-inflammatory drugs, healing drugs, and drugs that inhibit angiogenesis.

6. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The tail end of the ligation ring is provided with hollow gaps, the number of which is 2-6, the length is 0.5-6mm, and the width is 1-3mm.

7. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The outer surface of the ligation ring is coated with an antibacterial coating by dipping in an antibacterial solution. The antibacterial coating is one of a silver ion coating, a copper ion coating, a chlorhexidine coating, and a quaternary ammonium salt coating. The concentration of the antibacterial solution is 1%-10%.

8. The anti-detachment ligation ring for promoting blood coagulation according to claim 1, characterized in that: The ligation ring is made by flat plate molding, and its process flow is: charging, solution casting or injection molding, demoulding, preparing medicine, adding medicine into a multi-chamber structure, packaging, and sterilization.

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