Hemostasis device

Abstract

The embodiment of the invention provides a hemostasis device. The hemostasis device comprises a balloon catheter, the balloon catheter comprises a catheter body and a balloon, the first end of the catheter body is a penetrating end, and a first connector is arranged at the second end of the catheter body; the balloon is arranged outside the catheter body in a sleeving mode and communicated with an inner cavity of the catheter body, and the balloon is configured to be capable of being guided into the puncture opening and abut against the inner wall of the puncture opening after being full; the outer sheath tube assembly comprises an outer sheath tube body, a hemostasis plug and a movable connector; the catheter body is sleeved with the outer sheathing canal body, the far end of the outer sheathing canal body is sleeved with the hemostasis plug, and the movable connector is arranged at the near end of the outer sheathing canal body. The movable connector is movably connected with the balloon catheter, so that the outer sheath tube body can move in the axial direction of the catheter body; the hemostasis plug is configured to be capable of moving to the outside of the puncture opening and abut against the peripheral portion of the puncture opening.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a hemostatic device. Background Technology

[0002] Interventional vascular therapy has become the preferred treatment for vascular diseases. For example, percutaneous femoral (radial) artery intervention has become a commonly used clinical procedure. Percutaneous femoral (radial) artery intervention typically involves percutaneous femoral artery puncture, followed by the insertion of a catheter, balloon, and stent into the narrowed or blocked tubular artery for dilation and implantation, allowing blood to re-perfuse into the myocardial tissue to treat coronary artery disease. After the procedure, the arterial sheath on the femoral artery is removed, leaving a puncture hole in the femoral artery wall, which can cause bleeding.

[0003] For hemostasis at the femoral artery puncture site, manual compression and mechanically assisted compression are commonly used. Manual compression typically takes 20-30 minutes to achieve hemostasis, requiring pressure dressing and immobilization for 24 hours. Furthermore, manual compression can easily lead to complications such as pseudoaneurysms, retroperitoneal hemorrhage, and hematoma. Some patients are also unsuitable for manual compression, such as those unable to maintain prolonged supine position post-surgery, those on long-term antithrombotic medication, or those undergoing intraoperative thrombolytic therapy. Mechanically assisted compression applies pressure using a device (such as a pneumatic compression bandage). However, it does not allow direct observation of bleeding at the puncture site, thus failing to achieve the desired hemostatic effect.

[0004] To facilitate rapid and adequate hemostasis after surgery, reduce complications at the puncture site and patient suffering, and mitigate the potential risks associated with postoperative immobilization and bed rest, a novel technical solution is needed to address the aforementioned technical issues. Summary of the Invention

[0005] The purpose of this application is to provide a new technical solution for hemostasis devices.

[0006] This application provides a hemostatic device. The hemostatic device includes: a balloon catheter, comprising a catheter body and a balloon, wherein a first end of the catheter body is an insertion end, and a second end of the catheter body is provided with a first connector; the balloon is sleeved outside the catheter body and communicates with the inner lumen of the catheter body, and the balloon is configured to be guided into the puncture site and, after inflation, form an abutment against the inner wall of the puncture site; The outer sheath assembly includes the outer sheath body, a hemostatic plug, and a movable connector; The outer sheath body is sleeved outside the catheter body, the hemostatic plug is located at the distal end of the outer sheath body, and the movable connector is located at the proximal end of the outer sheath body; the movable connector is movably connected to the balloon catheter, allowing the outer sheath body to move along the axial direction of the catheter body; the hemostatic plug is configured to be movable to the outside of the puncture site and to abut against the peripheral portion of the puncture site.

[0007] Optionally, the balloon catheter further includes a handle, at least a portion of which is hollow. The catheter body includes a first catheter section and a second catheter section that are interconnected. At least a portion of the proximal end of the first catheter section is located within the hollow structure and the proximal end of the first catheter section is connected to one end of the second catheter section. The other end of the second catheter section is provided with the first connector.

[0008] Optionally, a first connecting portion is formed on a portion of the inner wall of the hollow structure, and a second connecting portion is formed on the outer wall of the movable connector. The first connecting portion and the second connecting portion cooperate to allow the movable connector to be movably connected to the balloon catheter.

[0009] Optionally, the handle also has a connecting hole, which is opened along the outer wall of the handle toward its hollow structure; at least a portion of the second conduit extends into the connecting hole and is connected to the proximal end of the first conduit.

[0010] Optionally, the second conduit portion is bent.

[0011] Optionally, the outer sheath assembly further includes an infusion assembly, which is disposed on the movable connector and communicates with the outer sheath body; an outlet hole is provided on the outer sheath body near the hemostatic plug.

[0012] Optionally, the infusion assembly includes an infusion catheter and a second connector, one end of the infusion catheter is disposed at the movable connector and communicates with the outer sheath body, and the other end of the infusion catheter is provided with a second connector.

[0013] Optionally, the hemostatic plug is a component made of biodegradable hydrogel, or the hemostatic plug is a component made of a hydrophilic polymer and potassium ferrate composite.

[0014] Optionally, the biodegradable hydrogel includes at least one of sodium alginate-based hydrogel, polyethylene glycol-based hydrogel, chitosan-based hydrogel, and starch-based hydrogel.

[0015] Optionally, the hydrophilic polymer includes at least one of chitosan, chitin, sodium carboxymethyl starch, polyvinylpyrrolidone, and polyacrylamide.

[0016] One technical advantage of this application is: This application provides a hemostatic device. The device includes a balloon catheter and an outer sheath assembly. The balloon catheter allows the balloon to be guided into the puncture site. After inflation, the balloon forms a tight seal with the inner wall of the puncture site. This inner layer sealing method can quickly block blood from flowing out of the blood vessel through the puncture site, reducing bleeding at its source. Simultaneously, the hemostatic plug in the outer sheath assembly can be moved to the outside of the puncture site and forms a tight seal with the peripheral area of ​​the puncture site, creating an outer layer seal. This double-layer sealing enhances the hemostatic effect, effectively reducing the risk of postoperative bleeding and preventing these complications, thus improving the safety and success rate of the surgery. Furthermore, the hemostatic device provided in this embodiment can achieve hemostasis quickly and effectively, reducing the time required to manage postoperative bleeding and the occurrence of related complications.

[0017] Other features and advantages of this specification will become clear from the following detailed description of exemplary embodiments with reference to the accompanying drawings. Attached Figure Description

[0018] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments of this specification and, together with their description, serve to explain the principles of this specification.

[0019] Figure 1 The diagram shows the structure of the hemostatic device provided in the embodiment of this application. Figure 1 .

[0020] Figure 2 The diagram shows the structure of the hemostatic device provided in the embodiment of this application. Figure 2 .

[0021] Figure 3 As shown Figure 2 A schematic diagram of the hemostatic device acting on the puncture site.

[0022] Figure 4 As shown Figure 2 Structural diagram of a mid-balloon catheter.

[0023] Figure 5 As shown Figure 2 Structural diagram of the inner and outer sheath assembly.

[0024] Explanation of reference numerals in the attached figures: 100. Piercing opening; 1. Balloon catheter; 10. Catheter body; 11. Balloon; 12. Handle; 101. First catheter section; 102. Second catheter section; 103. First connector; 121. Hollow structure; 122. Connecting hole; 1211. First connecting part; 2. Outer sheath assembly; 21. Outer sheath body; 22. Movable connector; 23. Hemostatic plug; 24. Infusion assembly; 241. Infusion catheter; 242. Second connector; 211. Infusion port; 221. Second connection part. Detailed Implementation

[0025] Various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the present application.

[0026] The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the scope of this application and its application or use.

[0027] Technologies and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such technologies and equipment should be considered part of the specification.

[0028] In all the examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0029] It should be noted that similar labels and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be discussed further in subsequent figures.

[0030] This application provides a hemostatic device, primarily used for hemostasis after puncture, and further applicable to areas such as repair of damaged thin-walled tissues within the human body. Specifically, this hemostatic device is particularly suitable for hemostasis at the arterial (or venous) puncture site after femoral (or radial) artery puncture or for hemostasis after puncture at other sites.

[0031] Reference Figures 1-2 The hemostatic device includes a balloon catheter 1 and an outer sheath assembly 2. The balloon catheter 1 includes a catheter body 10 and a balloon 11. The first end of the catheter body 10 is an insertion end, and the second end of the catheter body 10 is provided with a first connector 103. The balloon 11 is sleeved on the outside of the catheter body 10 and communicates with the inner lumen of the catheter body 10. The balloon 11 is configured to be guided into the puncture site 100 (i.e., the puncture port) and, after inflation, abut against the inner wall of the puncture site 100.

[0032] The outer sheath assembly 2 includes an outer sheath body 21, a hemostatic plug 23, and a movable connector 22. The outer sheath body 21 is sleeved on the outside of the catheter body 10. The hemostatic plug 23 is located at the distal end of the outer sheath body 21, and the movable connector 22 is located at the proximal end of the outer sheath body 21. The movable connector 22 is movably connected to the balloon catheter 1, allowing the outer sheath body 21 to move along the axial direction of the catheter body 10. The hemostatic plug 23 is configured to move to the outside of the puncture site 100 and abut against the peripheral portion of the puncture site 100.

[0033] In this embodiment, the balloon catheter 1 includes a catheter body 10 and a balloon 11. The first end (distal end) of the catheter body 10 is designated as the insertion end, used in clinical use to penetrate blood vessels and other human tissue sites to establish an operating channel. The second end of the catheter body 10 is equipped with a first connector 103, which is used for reliable connection with other related equipment or components such as a pressure pump to control the balloon 11. The balloon 11 is installed outside the catheter body 10 and remains in communication with the inner lumen of the catheter body 10. In practical applications, the balloon 11 can be guided into the puncture site 100 on blood vessels or other tissues, and then inflated by pressure. The inflated balloon 11 forms a tight seal with the inner wall of the puncture site 100, thereby achieving the purpose of initially sealing the puncture site 100 and reducing bleeding. For example, in a vascular interventional surgery scenario, the balloon catheter 1 is first passed through the puncture site 100 of the completed vascular interventional surgery via a surgical sheath to ensure that the balloon 11 can successfully enter the designated location inside the blood vessel. After the balloon 11 successfully reaches the inside of the blood vessel, a pressure pump connected to the first connector 103 is used to inflate the balloon 11. Under the action of the pressure pump, the balloon 11 gradually inflates to a suitable shape and pressure state.

[0034] After inflating balloon 11, slowly and precisely withdraw balloon catheter 1, simultaneously withdrawing the surgical sheath to the outer surface of the blood vessel. Continue withdrawing balloon catheter 1 until balloon 11 is withdrawn to the puncture site 100. At this point, adjust the position and orientation of balloon 11 to ensure it fits snugly against the inner wall of the blood vessel, thereby effectively sealing the inner wall of the puncture site 100 using the inflation state of balloon 11. Figure 3 The diagram shows the inflated balloon 11 abutting against the inner wall of the puncture site 100, and... Figure 3 The diagram also shows the subsequent contact between the hemostatic plug 23 and the peripheral portion of the puncture site 100.

[0035] It should be noted that during this procedure, the balloon catheter 1 is passed through the puncture site 100, where the vascular intervention surgery has already been performed, using a surgical sheath. The surgical sheath primarily serves a guiding role, ensuring that the balloon catheter 1 accurately and smoothly reaches the target location. In the field of medical devices, using a surgical sheath to guide the balloon catheter 1 is a standard technique employed by those skilled in the art. This is a widely accepted understanding and operational standard based on long-term technical accumulation and practical experience in this field; therefore, this standard guiding process will not be described in detail here.

[0036] In this embodiment, the outer sheath assembly 2 includes an outer sheath body 21, a hemostatic plug 23, and a movable connector 22. The outer sheath body 21 is sleeved onto the outside of the catheter body 10, providing support and guidance for the hemostatic plug 23. The hemostatic plug 23 is located at the distal end of the outer sheath body 21, which is the end closer to the puncture site 100 relative to the operating end. Exemplarily, the hemostatic plug 23 is detachably located at the distal end of the outer sheath body 21. The movable connector 22 is located at the proximal end of the outer sheath body 21, i.e., the end that is convenient for the operator to operate. The movable connector 22 is movably connected to the balloon catheter 1, allowing the outer sheath body 21 to move flexibly along the axial direction of the catheter body 10. The hemostatic plug 23 has a specific functional configuration. In actual use, the hemostatic plug 23 can move to the outside of the puncture site 100 under the drive of the outer sheath body 21, and form a tight contact with the outer periphery of the puncture site 100, further enhancing the hemostatic effect on the puncture site 100 and ensuring the reliability and effectiveness of hemostasis. For example, the hemostatic plug 23 is a polymer plug.

[0037] In this embodiment, after the inflated balloon 11 forms a tight contact with the inner wall of the puncture site 100, the movable connector 22 is adjusted and the outer sheath body 21 is pushed to move axially along the catheter body 10. The outer sheath body 21 drives the hemostatic plug 23 through the surgical sheath, so that the hemostatic plug 23 reaches the outer surface of the vascular puncture site 100. After the hemostatic plug 23 reaches the outer surface of the vascular puncture site 100, the surgical sheath is withdrawn, and pressure can be maintained on the puncture site for about 1-2 minutes to improve the hemostatic effect. After maintaining pressure on the puncture site for about 1 to 2 minutes, the balloon 11 is depressurized to reduce the internal pressure of the balloon 11 to a suitable state. Subsequently, the balloon 11, catheter body 10, outer sheath body 21, and movable connector 22 are removed from the body. After completing the above operations, apply pressure to the puncture site again with your hand and continue pressing for about 60 seconds. During this period, carefully observe the puncture site to determine whether effective hemostasis has been achieved, thereby ensuring that the entire hemostasis operation achieves the expected results.

[0038] For example, the hemostatic plug 23 is detachably disposed at the distal end of the outer sheath body 21, such as by fitting the hemostatic plug 23 onto the distal end of the outer sheath body 21, or as... Figure 3 and Figure 5 As shown, the hemostatic plug 23 is inserted at the distal end of the outer sheath body 21. When the hemostatic plug 23 is inserted at the distal end of the outer sheath body 21, a first insertion portion is formed at the distal end of the outer sheath body 21, and a second insertion portion is formed on the outer periphery of the hemostatic plug 23. The first insertion portion and the second insertion portion cooperate to allow the hemostatic plug 23 to be detachably disposed at the distal end of the outer sheath body 21.

[0039] In this embodiment, the balloon catheter 1 guides the balloon 11 into the puncture site 100. After inflation, the balloon 11 forms a tight seal with the inner wall of the puncture site 100. This inner layer sealing method can quickly block blood from flowing out of the blood vessel through the puncture site 100, reducing bleeding at the source. Simultaneously, the hemostatic plug 23 in the outer sheath assembly 2 can be moved to the outside of the puncture site 100 and forms a tight seal with the peripheral portion of the puncture site 100, creating an outer layer seal. This double-layer sealing enhances the hemostatic effect, effectively reducing the risk of postoperative bleeding and preventing these complications, thus improving the safety and success rate of the surgery. Furthermore, the hemostatic device provided in this embodiment can achieve hemostasis quickly and effectively, reducing the time required to manage postoperative bleeding and minimizing the occurrence of related complications.

[0040] Furthermore, in this embodiment, the movable connector 22 is movably connected to the balloon catheter 1, giving the outer sheath body 21 the ability to move flexibly along the axial direction of the catheter body 10. In actual operation, medical personnel can precisely adjust the position of the hemostatic plug 23 according to the specific location and size of the puncture site 100 and the individual differences of the patient, ensuring that it can accurately reach the outside of the puncture site 100 and achieve the best contact effect. This flexibility allows the hemostatic device to adapt to different patients' vascular conditions and surgical situations, improving the versatility and practicality of the device.

[0041] In the embodiments of this application, reference is made to Figure 1 , Figure 2 and Figure 4 The balloon catheter 1 further includes a handle 12, at least a portion of which is a hollow structure 121. The catheter body 10 includes a first catheter section 101 and a second catheter section 102 that are interconnected. At least a portion of the proximal end of the first catheter section 101 is located within the hollow structure 121 and the proximal end of the first catheter section 101 is connected to one end of the second catheter section 102. The other end of the second catheter is provided with the first connector 103.

[0042] In this embodiment, the balloon catheter 1 is further provided with a handle 12. At least a portion of the interior of the handle 12 is a hollow structure 121.

[0043] The catheter body 10 consists of a first catheter section 101 and a second catheter section 102 that are interconnected. At least a portion of the proximal end of the first catheter section 101 is housed within the hollow structure 121 of the handle 12, and the proximal end of the first catheter section 101 is securely connected to one end of the second catheter section 102. The other end of the second catheter section 102 is equipped with a first connector 103, which is used to connect with other related devices or components to enable various functional operations of the balloon catheter 1. For example, the first connector 103 can be connected to a pressure pump to control the inflation and deflation of the balloon 11. This structural design makes the connections between the components of the balloon catheter 1 compact and reasonable, ensuring the patency of the catheter body 10 while facilitating operation and control of the balloon catheter 1 by medical personnel through the handle 12.

[0044] For example, the first conduit portion 101 and the second conduit portion 102 can be an integral structure. Alternatively, the first conduit portion 101 and the second conduit portion 102 can be connected together by a connecting joint.

[0045] In the embodiments of this application, reference is made to Figure 1 , Figure 2 , Figure 4 and Figure 5 A first connecting portion 1211 is formed on a portion of the inner wall of the hollow structure 121, and a second connecting portion 221 is formed on the outer wall of the movable connector 22. The first connecting portion 1211 and the second connecting portion 221 cooperate to allow the movable connector 22 to be movably connected to the balloon catheter 1.

[0046] In this embodiment, by matching the shape and size of the first connecting part 1211 and the second connecting part 221, the movable connector 22 and the balloon catheter 1 are connected with high stability and reliability, reducing the risk of loosening or falling off the connection and ensuring the normal connection status of the device during use.

[0047] The movable connector 22 is movably connected to the balloon catheter 1. For example, the movable connector 22 is connected to the handle 12 of the balloon catheter 1 by a threaded connection, or the movable connector 22 is connected to the handle 12 of the balloon catheter 1 by a sliding connection.

[0048] When the movable connector 22 is connected to the handle 12 of the balloon catheter 1 by a threaded connection, the first connecting part 1211 is an internal thread structure formed inside the hollow structure 121, and the second connecting part 221 is an external thread structure formed on the outer wall of the movable connector 22.

[0049] When the movable connector 22 is connected to the handle 12 of the balloon catheter 1 by a sliding connection, the first connecting part 1211 is a groove structure formed inside the hollow structure 121, and the second connecting part 221 is a slider structure formed on the outer wall of the movable connector 22.

[0050] In the embodiments of this application, reference is made to Figure 1 , Figure 2 and Figure 4 The handle 12 is also provided with a connecting hole 122, which is opened along the outer wall of the handle 12 toward its hollow structure 121; at least a portion of the second conduit portion 102 extends into the connecting hole 122 and is connected to the proximal end of the first conduit portion 101.

[0051] In this embodiment, the handle 12 has a connecting hole 122, which is located along the outer wall of the handle 12 towards the hollow structure 121, providing a clear insertion path and positioning for the second conduit 102. This design allows the second conduit 102 to accurately extend into the connecting hole 122 and connect to the proximal end of the first conduit 101, avoiding deviations and misalignments during the connection process, ensuring the accuracy and reliability of the conduit system connection, and ensuring that fluids (such as liquids) can be smoothly transported within the conduit.

[0052] The connection of the conduit is achieved by opening a connecting hole 122 on the handle 12, which effectively utilizes the hollow space inside the handle 12, making the structure of the whole device more compact and improving the portability and operability of the device.

[0053] In the embodiments of this application, reference is made to Figure 1 , Figure 2 and Figure 4 The second conduit portion 102 is bent.

[0054] In this embodiment, the second conduit portion 102 is bent, altering the orientation of the conduit body 10, allowing the conduit body 10 to be arranged more rationally within a limited space. For example, the bent second conduit portion 102 can bypass other electronic components or structural parts, achieving compact integration of various components, reducing the overall size of the device, and improving the portability of the device.

[0055] In the embodiments of this application, reference is made to Figure 2 and Figure 5 The outer sheath assembly 2 further includes an infusion assembly 24, which is disposed on the movable connector 22 and communicates with the outer sheath body 21; an outlet hole 211 is provided on the outer sheath body 21 near the hemostatic plug 23.

[0056] In this embodiment, the hemostatic device can not only stop bleeding, but also provide drug treatment to the puncture site 100 (i.e., the bleeding site) after the hemostatic operation is completed, providing the patient with a more comprehensive treatment method, which helps to accelerate wound healing and relieve patient pain.

[0057] When using this hemostatic device, the hemostatic plug 23 plays a major role. The hemostatic plug 23 is precisely applied to the site where hemostasis is required, and using its special material (such as a biodegradable hydrogel material), the hemostatic plug 23 can quickly achieve an effective hemostatic effect.

[0058] While the hemostatic plug 23 exerts its hemostatic effect, the infusion assembly 24 begins to operate. The infusion assembly 24 is connected to the outer sheath body 21 and can simultaneously inject medication into the affected area. Specifically, the medication is transported through the infusion assembly 24 into the outer sheath body 21, and then through the outer sheath body 21 to the distal outlet 211 at the tail end of the outer sheath body 21. The medication acts on the affected area through the outlet 211. The design of the distal outlet 211 at the tail end of the outer sheath body 21 allows the medication to be precisely delivered to the puncture site 100, directly acting on the injured tissue, increasing the local drug concentration, enhancing the therapeutic effect, while reducing the distribution of the medication throughout the body and lowering the risk of drug side effects.

[0059] The injectable medications include procoagulants and analgesics / anti-inflammatory drugs. Procoagulants, such as thrombin and tranexamic acid, accelerate the blood clotting process, enhance hemostasis, further solidify the hemostatic state established by the hemostatic plug 23, and reduce the risk of bleeding. Analgesics and anti-inflammatory drugs can relieve pain and inflammation caused by the wound, improve patient comfort, and promote wound healing.

[0060] For example, a plurality of fluid outlet holes 211 are provided on the outer sheath body 21 near the hemostatic plug 23.

[0061] In the embodiments of this application, reference is made to Figure 2 and Figure 5 The infusion assembly 24 includes an infusion catheter 241 and a second connector 242. One end of the infusion catheter 241 is disposed at the movable connector 22 and communicates with the outer sheath body 21, and the other end of the infusion catheter 241 is provided with the second connector 242.

[0062] In this embodiment, one end of the infusion catheter 241 is located at the movable connector 22 and communicates with the outer sheath body 21. This connection method allows the medication to smoothly enter the outer sheath body 21 through the infusion catheter 241 and reach the hemostatic site. The second connector 242 at the other end of the infusion catheter 241 is used to connect to an external medication supply source. When medication treatment is required, medical personnel can connect a syringe or infusion bag containing procoagulant drugs, analgesics, anti-inflammatory drugs, etc., to the infusion catheter 241 through the second connector 242 to introduce the medication into the infusion assembly 24.

[0063] In the embodiments of this application, the hemostatic plug 23 is a component made of biodegradable hydrogel, or the hemostatic plug 23 is a component made of a hydrophilic polymer and potassium ferrate composite.

[0064] In this embodiment, the hemostatic plug 23 is specifically a polymer hemostatic plug 23, and the material of the hemostatic plug 23 is a biodegradable hydrogel. For example, the polymer plug reaches the hemostasis site by forming a biodegradable hydrogel and can bind to drugs to stop bleeding. After contacting blood, the biodegradable hydrogel can rapidly absorb water from the blood and swell, forming a physical barrier that compresses the damaged blood vessel site, effectively preventing further blood loss. In addition, the matrix material and degradation products of the biodegradable hydrogel are non-toxic and have good biocompatibility. They do not produce significant toxic side effects on the human body, reducing the risks during treatment.

[0065] Specifically, the biodegradable hydrogel includes at least one of sodium alginate-based hydrogel, polyethylene glycol-based hydrogel, chitosan-based hydrogel, and starch-based hydrogel.

[0066] The hemostatic mechanism of sodium alginate-based hydrogel is as follows: Sodium alginate is a natural polysaccharide widely used in hemostatic materials. Sodium alginate forms a three-dimensional network structure by undergoing ion exchange reaction with divalent cations in the blood (such as Ca2+ and Ba2+), absorbing water from the blood to form a gel, thereby blocking capillaries, promoting platelet aggregation and the release of coagulation factors, and achieving hemostasis.

[0067] The hemostatic mechanism of polyethylene glycol hydrogels: After contacting tissue, polyethylene glycol hydrogels rapidly form a porous or gel structure, directly and physically blocking the bleeding point to achieve hemostasis.

[0068] The hemostatic mechanism of chitosan-based hydrogels: Chitosan is a natural polysaccharide. When it comes into contact with tissue, its amino groups are protonated to form -NH3+ groups. The electrostatic interaction of these groups can increase platelet adhesion, promote the adhesion and aggregation of erythrocytes at the damaged site, accelerate thrombus formation, and achieve hemostasis.

[0069] The hemostatic mechanism of starch-based hydrogels: Starch-based hydrogels typically have a microporous structure (such as microporous starch). Their large specific surface area and high porosity allow them to rapidly absorb water from the blood, forming a gel layer. This physical adsorption mechanically seals the ruptured blood vessel, preventing blood flow and achieving hemostasis.

[0070] In another example of this embodiment, the hemostatic plug 23 is specifically a polymer hemostatic plug 23, and the material of the hemostatic plug 23 is a composite material of hydrophilic polymer and potassium ferrate.

[0071] The hemostatic mechanism of the hydrophilic polymer-potassium ferrate composite material is as follows: The hydrophilic polymer possesses excellent hydrophilic properties, enabling it to rapidly contact and dehydrate blood while efficiently absorbing exudate from the wound. During this process, the dehydrated blood clot continuously accumulates, forming a dense sealing layer at the wound surface. Potassium ferrate plays a solidification role in the hemostatic process of this composite material. It promotes cross-linking reactions between the blood clot and proteins, solidifying the originally loose sealing layer and tightly adhering it to the wound surface, thereby effectively blocking blood exudation. Notably, the sealing layer formed by this composite material exhibits a unique pH environment distribution. Below the sealing layer, a neutral pH environment is maintained, which is conducive to the continuous and natural accumulation of blood clots and proteins, further enhancing the sealing effect. On the surface of the sealing layer, an acidic environment with a pH of approximately 2 is formed. This acidic environment not only has a drying effect but also effectively inhibits bacterial growth and reproduction, exhibiting a good antibacterial effect. In addition, this sealing layer can not only achieve rapid hemostasis upon contact with the wound, but also continuously enhance its sealing effect over time and with artificially applied pressure, providing long-lasting and reliable hemostatic protection for the wound.

[0072] Specifically, the hydrophilic polymers include at least one of chitosan, chitin, sodium carboxymethyl starch, polyvinylpyrrolidone, and polyacrylamide. These hydrophilic polymers each possess unique chemical structures and physical properties, playing a crucial role in hemostatic composite materials. Chitosan exhibits good biocompatibility and biodegradability; the amino groups in its molecules can interact with negatively charged components in blood, promoting blood clotting. Chitin, as a precursor to chitosan, also possesses excellent hydrophilicity and bioactivity. Sodium carboxymethyl starch has a strong water absorption and swelling capacity, rapidly absorbing water from the blood to form a gel-like substance. Polyvinylpyrrolidone has good solubility and stability, effectively binding with components such as proteins in the blood. Polyacrylamide has high water absorption and retention properties, helping to form a stable sealing layer on the wound surface.

[0073] The above embodiments mainly describe the differences between the various embodiments. As long as the different optimization features between the various embodiments are not contradictory, they can be combined to form a better embodiment. For the sake of brevity, they will not be elaborated here.

[0074] While specific embodiments of this application have been described in detail by way of examples, those skilled in the art should understand that the above examples are for illustrative purposes only and are not intended to limit the scope of this application. Those skilled in the art should understand that modifications can be made to the above embodiments without departing from the scope and spirit of this application. The scope of this application is defined by the appended claims.

Claims

1. A hemostatic device, characterized by, The application relates to a balloon catheter (1) and an outer sheath tube assembly (2). The balloon catheter (1) comprises a catheter body (10) and a balloon (11), a first end of the catheter body (10) is a penetrating end, and a second end of the catheter body (10) is provided with a first joint (103); the balloon (11) is sleeved outside the catheter body (10) and communicates with an inner cavity of the catheter body (10), and the balloon (11) is configured to be guided to the inside of a puncture hole and abut against the inner wall of the puncture hole after being filled. The outer sheath tube assembly (2) comprises an outer sheath tube body (21), a hemostatic plug (23) and a movable joint (22). The outer sheath tube body (21) is sleeved outside the catheter body (10), the hemostatic plug (23) is arranged at the distal end of the outer sheath tube body (21), and the movable joint (22) is arranged at the proximal end of the outer sheath tube body (21); the movable joint (22) is movably connected with the balloon catheter (1), so that the outer sheath tube body (21) can move along the axial direction of the catheter body (10); and the hemostatic plug (23) is configured to be moved to the outside of the puncture hole and abut against the peripheral part of the puncture hole.

2. The hemostatic device of claim 1, wherein, The balloon catheter (1) further comprises a handle (12), at least part of the inside of the handle (12) is a hollow structure (121), the catheter body (10) comprises a first catheter part (101) and a second catheter part (102) which are in communication with each other, at least part of the proximal end of the first catheter part (101) is located in the hollow structure (121), and the proximal end of the first catheter part (101) is connected with one end of the second catheter part (102), and the other end of the second catheter part is provided with the first joint (103).

3. The hemostatic device of claim 2, wherein, Part of the inner wall of the hollow structure (121) is provided with a first connecting part (1211), the outer wall of the movable joint (22) is provided with a second connecting part (221), and the first connecting part (1211) and the second connecting part (221) are matched to movably connect the movable joint (22) with the balloon catheter (1).

4. The hemostatic device of claim 2, wherein, The handle (12) is further provided with a communication hole (122), the communication hole (122) is arranged along the outer wall of the handle (12) and towards the hollow structure (121), at least part of the second catheter part (102) is inserted into the communication hole (122) and connected with the proximal end of the first catheter part (101).

5. The hemostatic device of claim 4, wherein, The second catheter part (102) is in a bent shape.

6. The hemostatic device according to any one of claims 1-5, wherein, The outer sheath tube assembly (2) further comprises a transfusion assembly (24), the transfusion assembly (24) is arranged on the movable joint (22) and communicates with the outer sheath tube body (21); and a liquid outlet hole (211) is arranged on the outer sheath tube body (21) and close to the hemostatic plug (23).

7. The hemostatic device of claim 6, wherein, The infusion assembly (24) comprises an infusion catheter (241) and a second connector (242), one end of the infusion catheter (241) is arranged in the movable connector (22) and communicates with the sheath body (21), and the other end of the infusion catheter (241) is provided with the second connector (242).

8. The hemostatic device of claim 1, wherein, The hemostatic plug (23) is a component prepared from degradable hydrogel, or the hemostatic plug (23) is a component prepared from a hydrophilic polymer and potassium ferrate.

9. The hemostatic device of claim 8, wherein, The degradable hydrogel comprises at least one of a sodium alginate-based hydrogel, a polyethylene glycol-based hydrogel, a chitosan-based hydrogel and a starch-based hydrogel.

10. The hemostatic device of claim 8, wherein, The hydrophilic polymer comprises at least one of chitosan, chitin, sodium carboxymethyl starch, polyvinylpyrrolidone and polyacrylamide.

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