Negative pressure adsorption type hemostat

Abstract

The invention discloses a negative pressure adsorption type hemostat, which comprises a main body part, which comprises a shell with a cavity, and the bottom of the shell is provided with an opening part; a negative pressure control assembly is arranged in the shell and used for communicating with the cavity under the action of suction force so as to extract air flow and blocking communication when the cavity is in a negative pressure state and the suction force is removed so as to keep the negative pressure state of the cavity. The opening part is provided with a plugging piece which can be adhered to the skin; a rigid blocking structure is arranged in the cavity, the blocking piece comprises a first area opposite to the blocking structure and a second area located on at least one side of the first area, the first area is used for abutting against the corresponding position of a target blood vessel, and the second area can contract and deform under the action of negative pressure in the cavity. According to the hemostat, a non-direct compression hemostasis mode is achieved, the defects of traditional manual compression and mechanical compression devices in the aspects of safety, comfort and operation complexity are overcome, and the limitation of a blood vessel closer in the aspects of cost and application range is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical hemostatic devices, and particularly relates to a negative pressure adsorption type hemostat. BACKGROUND

[0002] Radial artery intervention surgery is a common cardiovascular diagnosis and treatment method, and is widely used in the field of coronary artery intervention treatment. After the operation is completed, effective hemostasis of the radial artery puncture approach is an important link to ensure the safety of the operation and the recovery of the patient.

[0003] The traditional hemostatic method mainly relies on manual pressing, that is, medical staff manually and continuously press the puncture site to achieve the purpose of hemostasis. However, this method has many disadvantages: first, manual pressing needs a long time of continuous operation, which is time-consuming, labor-consuming and low in efficiency; second, the pressing force is difficult to accurately control, which may damage the vascular endothelium due to excessive compression, induce local thrombosis, or fail to achieve hemostasis due to insufficient compression; in addition, long-term direct compression of the wound often causes obvious pain, and the patient experience is poor; at the same time, the patient needs to lie in bed for a long time after the operation, which increases the risk of deep vein thrombosis and discomfort; finally, manual pressing relies on the operation of medical staff throughout the process, which is high in labor cost.

[0004] In order to overcome the defects of manual pressing, mechanical compression devices are currently widely used in radial artery intervention surgery for hemostasis. However, such devices also have significant problems: first, the device is large in size and high in cost of consumables; second, direct compression of the wound still causes pain to the patient; in addition, the operation is complex and requires medical staff who have undergone special training to reduce the pressure in stages, which increases the operation difficulty; at the same time, the device has a large compression area, which easily causes poor blood supply near the wound and other discomfort symptoms; more seriously, too tight compression may cause radial artery occlusion, with a reported occlusion rate of 3%-10%.

[0005] As a high-end hemostatic solution, a vascular closure device has also been applied in clinical practice in recent years. The device achieves hemostasis by implanting or sealing the puncture site, but its application is limited: on the one hand, it is high in cost and difficult to be widely promoted; on the other hand, it is not suitable for patients with too small blood vessels or severe calcification; in addition, improper operation may cause complications such as foreign body reaction or embolism, which has certain safety hazards.

[0006] In summary, the existing hemostatic technology has deficiencies in efficiency, safety, patient comfort and cost, and it is difficult to meet the clinical demand for efficient, low-cost and non-invasive hemostasis after radial artery intervention surgery. SUMMARY

[0007] The purpose of the present application is to provide a negative pressure adsorption type hemostat which can replace manual hemostasis of skin blood vessels and has a simple structure and operation.

[0008] In order to achieve the above object, the present application provides a negative pressure adsorption type hemostat, which comprises: a main body part comprising a shell having a cavity, the bottom of the shell having an opening part communicating with the cavity; a negative pressure control assembly arranged in the shell, the negative pressure control assembly being used for communicating the cavity under the action of suction force to extract air flow, and being used for blocking the communication to maintain the negative pressure state of the cavity after the suction force is removed when the cavity is in the negative pressure state; the opening part is provided with a blocking member capable of adhering to the epidermis; a rigid blocking structure is arranged in the cavity, the blocking member comprises a first region opposite to the blocking structure and a second region located on at least one side of the first region, the first region is used for abutting against the corresponding position of the target blood vessel, and the second region can be shrunk and deformed under the action of negative pressure in the cavity.

[0009] Preferably, a containing groove is further arranged in the shell, a first through hole communicating with the cavity is arranged in the containing groove; the negative pressure control assembly is arranged in the containing groove, and the negative pressure control assembly adjusts the air pressure state of the cavity by controlling the opening or closing of the first through hole.

[0010] Preferably, the first through hole is located on the bottom wall of the containing groove.

[0011] Preferably, the negative pressure control assembly comprises a valve nozzle arranged in the containing groove and in a cylindrical structure, and a valve core connected with the valve nozzle, the valve nozzle is used for being connected with an air flow extractor, and the valve core is used for opening or closing the first through hole.

[0012] Preferably, the bottom of the valve nozzle is provided with a second through hole, the valve core comprises a base and a limiting part, the limiting part is connected with the base through a rod part, the diameter of the rod part is smaller than that of the second through hole, the diameter of the limiting part is greater than that of the second through hole, the rod part passes through the second through hole, and the limiting part is located in the valve nozzle; based on the air pressure difference on both sides of the base, the base has a first state position of closing the first through hole and a second state position of opening the first through hole.

[0013] Preferably, there is a gap between the valve nozzle and the bottom wall of the containing groove, the base is located in the gap, and the valve core can move in the valve core so that the base is in the first state position or the second state position.

[0014] Preferably, a window is further arranged on the side wall of the valve nozzle, by means of which the gap is in communication with the internal space of the valve nozzle; so that when the base is in the second state, the air flow in the cavity enters the valve nozzle in turn via the first through hole, the gap and the window.

[0015] Preferably, an annular step for interfacing with a suction device is further arranged in the valve nozzle.

[0016] Preferably, a fixing part connected with the shell is further included, which is used for fixing the main part at a target site of the skin.

[0017] Preferably, the fixing part includes flexible bands connected with opposite sides of the shell, and free ends of the two flexible bands are based on separable connection.

[0018] Compared with the prior art, the above technical solution provides a negative pressure suction type hemostat, which draws air flow from the cavity under the action of suction force through the negative pressure control assembly, and blocks the communication to maintain the negative pressure state after the suction force is removed, and combines the sealing piece with the skin to adhere to form stable suction, avoiding uneven force of manual pressing, thereby reducing the risk of vascular spasm or occlusion. In addition, the blocking structure divides the sealing piece into a first area (corresponding to the abutment of the target blood vessel) and a second area (shrinking and deforming under negative pressure), so that the compression range is more concentrated on the position of the target blood vessel, which not only improves the hemostatic efficiency and reduces the incidence of hematoma, but also significantly shortens the hemostatic time and reduces the discomfort caused by long-term compression. At the same time, since it does not involve foreign body implantation, complications such as foreign body reaction or embolism are avoided, and the safety is higher. In addition, the structural design of the present scheme is relatively simple, and the use cost is significantly lower than that of the vascular closure device, which has better economy. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 It is a perspective view of the hemostat in the embodiment of the present application.

[0020] Figure 2 It is a sectional view of the shell in the embodiment of the present application.

[0021] Figure 3 It is a sectional view of the main part of the hemostat in the embodiment of the present application, wherein the hemostat is in a non-use state.

[0022] Figure 4 It is a sectional view of the valve nozzle in the embodiment of the present application.

[0023] Figure 5 It is a sectional view of the main part of the hemostat in the embodiment of the present application, wherein the hemostat is in a negative pressure maintaining state.

[0024] Figure 6A sectional view of the main body of the tourniquet in the embodiment of the present application, wherein the tourniquet is in a negative pressure state.

[0025] Figure 7 A perspective view of the negative pressure control assembly in the embodiment of the present application.

[0026] Figure 8 A perspective view of the valve core in the embodiment of the present application. Figure 7 A perspective view of the valve core in the embodiment of the present application.

[0027] Figure 9 A perspective view of the valve core in the embodiment of the present application. DETAILED DESCRIPTION

[0028] To make the technical content, structural features, achieved purposes and effects of the present application clear, the following will be described in detail in combination with the embodiments and the accompanying drawings.

[0029] The present embodiment discloses a negative pressure adsorption type tourniquet, which is suitable for the hemostasis operation of the puncture site after radial artery intervention surgery, but is not limited thereto.

[0030] As Figures 1 to 6 , the tourniquet comprises a main body A, which comprises a shell 1 having a cavity 10, the shell 1 is made of medical grade hard plastic, which has sufficient rigidity to maintain structural stability.

[0031] The bottom of the shell 1 is provided with an opening part 11 communicating with the cavity 10, the size of the opening part 11 is adapted to cover the epidermis area of the puncture site of the human radial artery and its surrounding area, so as to ensure the effectiveness of the hemostasis operation.

[0032] A negative pressure control assembly 3 is arranged in the shell 1, which communicates with the cavity 10 and is used to regulate the air pressure state in the cavity 10.

[0033] Specifically, the negative pressure control assembly 3 can communicate the cavity 10 under the action of external suction force (such as through connection with an air flow suction device), so as to suck out the air flow in the cavity 10 and form a negative pressure state inside the cavity 10; when the suction force is removed, the negative pressure control assembly 3 can block the communication between the cavity 10 and the external environment, so as to maintain the negative pressure state in the cavity 10 unchanged.

[0034] A sealing member 2 is arranged at the opening part 11, which is made of flexible medical silicone material (or other flexible medical material) and has good biocompatibility and epidermal adhesion.

[0035] The sealing member 2 covers the entire opening part 11 and is fixedly connected with the bottom edge of the shell 1 by adhesion or ultrasonic welding, so as to ensure the sealing property of the cavity 10 under the negative pressure state.

[0036] The blocking member 2 can closely adhere to the skin surface when in contact with the skin surface, forming an effective adsorption effect, thereby stably fixing the hemostat to the puncture site.

[0037] A rigid blocking structure 12 is arranged inside the cavity 10, which is made of the same or similar hard material as the shell 1 and is fixedly connected to the position inside the shell 1 close to the opening part 11. The blocking structure 12 divides the blocking member 2 into two regions: a first region 20 and a second region 21.

[0038] The first region 20 is opposite to the blocking structure 12 and abuts against the corresponding position of the target blood vessel (for example, the radial artery puncture site) when the hemostat is used. The second region 21 is located on at least one side of the first region 20, and in this embodiment, the opposite two sides of the first region 20 each have a second region 21.

[0039] When the cavity 10 is in a negative pressure state, the second region 21 is subjected to the negative pressure effect and shrinks and deforms (as shown in Figure 5 and Figure 6 ), and is recessed towards the inside of the cavity 10.

[0040] In use, first, the blocking member 2 of the hemostat is aligned with the radial artery puncture site of the patient, and the blocking member 2 is attached to the skin surface, at this time, the blocking member 2 is in a normal extended state (as shown in Figure 3 ). Then, the negative pressure control assembly 3 is connected to an external airflow suction device to extract the airflow in the cavity 10, forming a negative pressure environment, at this time, the second region 21 of the blocking member 2 shrinks and deforms under the action of the negative pressure (as shown in Figure 6 ). Since the blocking structure 12 cannot deform, and the first region 20 of the blocking member 2 below the blocking structure 12 is directly above the blood vessel, the tissue above the blood vessel does not shrink and deform, only the tissue on both sides of the blood vessel is deformed upwards. This deformation promotes the skin and bleeding port to become tight and appear compression, so that hemostasis can be successful. Finally, the suction force is removed, the negative pressure control assembly 3 is blocked, the negative pressure state of the cavity 10 is maintained, and the stability and hemostasis effect of the hemostat are ensured.

[0041] In the traditional manual pressing hemostasis mode, it is difficult to control the pressing force, which easily leads to radial artery spasm or occlusion, and long-time pressing causes discomfort to patients and consumes a large amount of medical resources. In the embodiment, the negative pressure control assembly 3 is connected to the cavity 10 under the action of the suction force to draw air flow, and after the suction force is removed, the connection is blocked to maintain the negative pressure state, and the stable adsorption is formed by the adhesion of the blocking piece 2 and the skin, which avoids the uneven force of manual pressing, thereby reducing the risk of radial artery spasm or occlusion. In addition, the blocking structure 12 divides the blocking piece 2 into a first area 20 (corresponding to the abutment of the target blood vessel) and a second area 21 (shrinking deformation under negative pressure), so that the compression range is more concentrated on the position of the target blood vessel, which not only improves the hemostasis efficiency and reduces the incidence of hematoma, but also significantly shortens the hemostasis time, reduces the discomfort caused by long-time compression, reduces the waste of medical resources, speeds up the recovery of patients, and shortens the hospitalization time.

[0042] Secondly, the existing mechanical compression device usually adopts large-area direct compression, which leads to problems such as blocked venous blood return, limb swelling, radial nerve branch compression, and hand numbness, and needs to be decompressed in stages, which is complex to operate. In the embodiment, the negative pressure adsorption mechanism replaces direct mechanical compression, and with the local deformation of the blocking piece 2 and the restriction of the blocking structure 12, a smaller hemostasis compression range is achieved, thereby reducing the influence on the venous blood return and the risk of limb swelling, effectively balancing hemostasis and blood circulation. At the same time, since direct compression of the radial nerve branch is avoided, the possibility of nerve damage and hand numbness is reduced. In addition, the negative pressure control assembly 3 automatically maintains the negative pressure state of the cavity 10, without the need for staged adjustment of air pressure, simplifying the operation process and further reducing the waste of medical resources. Most importantly, since the blood vessels are not directly compressed, the risk of radial artery occlusion is significantly reduced, effectively protecting the radial artery puncture approach, which is particularly important for patients who need multiple radial artery puncture approaches.

[0043] Furthermore, the hemostasis mode based on negative pressure adsorption and deformation of the blocking piece 2 in the embodiment does not require the implantation of foreign matter or special surgery, is simple and fast to operate, has a wider application range, and is particularly suitable for patients with smaller blood vessels. At the same time, since it does not involve the implantation of foreign matter, complications such as foreign matter reaction or embolism are avoided, and the safety is higher. In addition, the structural design of the scheme is relatively simple, and the use cost is significantly lower than that of the vascular closure device, which has better economy and promotion value.

[0044] On the other hand, as Figure 2 The shell 1 is also provided with a containing groove 13, and the containing groove 13 is provided with a first through hole 14 communicated with the cavity 10. The negative pressure control assembly 3 is arranged in the containing groove 13, and the negative pressure control assembly 3 adjusts the air pressure state of the cavity 10 by controlling the opening or closing of the first through hole 14.

[0045] In use, the external air flow suction device is connected to the interface at the top of the accommodation groove 13, and the suction force is started. At this time, the negative pressure control assembly 3 opens the first through hole 14, the air flow in the cavity 10 is sucked out, and a negative pressure state is formed. After the suction force is removed, the negative pressure control assembly 3 closes the first through hole 14, blocking the communication between the cavity 10 and the outside, maintaining the negative pressure state of the cavity 10, and ensuring the stability and hemostasis effect of the hemostat.

[0046] By providing the accommodation groove 13 and the first through hole 14 in the shell 1, and placing the negative pressure control assembly 3 in the accommodation groove 13 to control the opening and closing of the first through hole 14, the air pressure state of the cavity 10 is accurately controlled, the formation and maintenance of the negative pressure environment are ensured, and the use stability and operation convenience of the hemostat are further improved.

[0047] Specifically, the first through hole 14 is located on the bottom wall of the accommodation groove 13.

[0048] The first through hole 14 is arranged on the bottom wall of the accommodation groove 13, so that the air flow path between the negative pressure control assembly 3 and the cavity 10 is more direct and smooth. When the negative pressure control assembly 3 opens the first through hole 14 under the action of the suction force, the air flow in the cavity 10 can be quickly sucked out through the first through hole 14 on the bottom wall, avoiding the problem of reduced suction efficiency caused by too long or complex air flow path, thereby accelerating the formation speed of the negative pressure state in the cavity 10, improving the response efficiency of the hemostat, and helping to quickly achieve the hemostasis effect in clinical operation.

[0049] On the other hand, as Figures 3 to 9 The negative pressure control assembly 3 includes a valve nozzle 30 arranged in the accommodation groove 13 and having a cylindrical structure, and a valve core 31 connected with the valve nozzle 30, the valve nozzle 30 is used for docking with the air flow suction device, and the valve core 31 is used for opening or closing the first through hole 14.

[0050] Specifically, the valve nozzle 30 is made of medical-grade hard plastic or metal material, one end of which is fixed to the bottom of the accommodation groove 13 and extends upward to form an interface for docking with the external air flow suction device, so as to apply the suction force through the air flow suction device during operation.

[0051] The valve core 31 is made of elastic material or hard material and can move axially along the valve nozzle 30 under the action of the suction force to open or close the first through hole 14.

[0052] Through the arrangement of the valve nozzle 30 and the valve core 31, the air pressure state of the cavity 10 is accurately controlled. The valve nozzle 30 serves as the docking component with the air flow suction device, ensuring the effective transmission of the suction force, and the valve core 31 controls the opening and closing of the communication channel by moving, providing reliable sealing and negative pressure maintenance capability, further improving the operation convenience and use stability of the hemostat.

[0053] Further, the bottom of the valve nozzle 30 is provided with a second through hole 300, the valve core 31 comprises a base 310 and a limiting portion 311, the limiting portion 311 is connected with the base 310 through a rod portion 312, the diameter of the rod portion 312 is smaller than the diameter of the second through hole 300, the diameter of the limiting portion 311 is larger than the diameter of the second through hole 300, the rod portion 312 passes through the second through hole 300, and the limiting portion 311 is located in the valve nozzle 30. Based on the pressure difference on both sides of the base 310, the base 310 has a first state position of closing the first through hole 14 and a second state position of opening the first through hole 14.

[0054] In the embodiment, the base 310 of the valve core 31 is a circular sheet, and the limiting portion 311 is a mushroom head structure vertically protruding from the center of the base 310. Since the diameter of the rod portion 312 is smaller than the diameter of the second through hole 300, and the diameter of the limiting portion 311 is larger than the diameter of the second through hole 300, the rod portion 312 can move up and down in the second through hole 300, and the limiting portion 311 will not be separated from the valve nozzle 30.

[0055] When the air flow is sucked through the valve nozzle 30, under the action of the suction force, the base 310 is separated from the first through hole 14 and adheres to the outer bottom wall of the valve nozzle 30, thereby entering the second state position, and in this process, the rod portion 312 of the valve core 31 moves into the valve nozzle 30 in the second through hole 300. After the suction is completed, since the air pressure in the valve nozzle 30 is greater than the air pressure in the cavity 10 in the shell 1, the base 310 of the valve core 31 is pushed away from the valve nozzle 30 and adheres to the first through hole 14, thereby entering the first state position, so that the cavity 10 in the shell 1 is in a sealed state.

[0056] Specifically, the valve nozzle 30 has a gap X with the bottom wall of the accommodating groove 13, the base 310 is located in the gap X, and the valve core 31 can move in the valve core 31 to make the base 310 be in the first state position or the second state position.

[0057] On the other hand, the side wall of the valve nozzle 30 is also provided with a window 301, by means of which the gap X is in communication with the internal space of the valve nozzle 30; so that when the base 310 is in the second state, the air flow in the cavity 10 enters the valve nozzle 30 in sequence through the first through hole 14, the gap X and the window 301.

[0058] The total working principle of the negative pressure control assembly 3 with the above structure is as follows: After the plugging member 2 is aligned with the hemostatic site and the shell 1 is fixed (such as Figure 3 ), the valve nozzle 30 is connected with the suction device to outwardly suck the air flow. At this time, the valve core 31 moves towards the valve nozzle 30, so that the base 310 of the valve core 31 is separated from the first through hole 14 to open the first through hole 14 (such as Figure 6). Then, the air flow in the cavity 10 enters the gap X through the first through hole 14, and enters the valve nozzle 30 based on the gap X and the window 301 on the valve nozzle 30, and is then sucked out. After the suction is completed, the suction device is separated from the valve nozzle 30. At this time, since the air pressure (atmospheric pressure) in the valve nozzle 30 is greater than the air pressure in the cavity 10 in the shell 1, the valve core 31 is pushed away from the valve nozzle 30 under the action of the air pressure difference, so that the base 310 is attached to the first through hole 14 (as shown in Figure 5 ), to maintain the negative pressure state of the cavity 10, so that the sealing member 2 always remains in the contracted deformed state, achieving a stable hemostasis effect.

[0059] On the other hand, the valve nozzle 30 is also provided with an annular step 302 for docking with the suction device, so as to facilitate the docking of the suction device with the valve nozzle 30 and avoid damage to the valve core 31.

[0060] On the other hand, the valve nozzle 30 is also provided with an annular step 302 for docking with the suction device, so as to facilitate the docking of the suction device with the valve nozzle 30 and avoid damage to the valve core 31. Figure 1 In addition, the hemostat also includes a fixed part B connected with the shell 1, which is used to fix the main part A at the target site of the skin, so as to ensure the stability of the main part A during the hemostasis process and save manpower.

[0061] Further, the fixed part B includes two flexible bands 4 connected with the opposite sides of the shell 1, and the free ends of the two flexible bands 4 are based on a detachable connection.

[0062] In this embodiment, when in use, the two flexible bands 4 are tied around the wrist of the patient or other parts that need to be hemostatic, so as to fix the main part A. The two flexible bands 4 can be connected by any one of magic tape, snap and hook.

[0063] The above only discloses the preferred embodiments of the present application, and of course cannot limit the scope of the patent rights of the present application, so the equivalent changes made in the patent application scope of the present application still belong to the scope covered by the present application.

Claims

1. A negative pressure adsorption hemostat, characterized in that, include: The main body includes a housing with a cavity, the bottom of which has an opening communicating with the cavity; The housing is provided with a negative pressure control component, which is used to connect the cavity under the action of suction force to extract airflow, and to block the connection after the cavity is in a negative pressure state and the suction force is removed to maintain the negative pressure state of the cavity. The opening is provided with a sealing element that can adhere to the skin; The cavity is provided with a rigid blocking structure. The sealing member includes a first region opposite to the blocking structure and a second region located on at least one side of the first region. The first region is used to abut against the corresponding position of the target blood vessel, and the second region can contract and deform under the negative pressure in the cavity.

2. The negative pressure adsorption hemostat according to claim 1, characterized in that, The housing is further provided with a receiving groove, and the receiving groove is provided with a first through hole communicating with the cavity; a negative pressure control component is provided in the receiving groove, and the negative pressure control component regulates the air pressure state of the cavity by controlling the opening or closing of the first through hole.

3. The negative pressure adsorption hemostat according to claim 2, characterized in that, The first through hole is located on the bottom wall of the receiving groove.

4. The negative pressure adsorption hemostat according to claim 2, characterized in that, The negative pressure control component includes a valve nozzle disposed in the accommodating groove and having a cylindrical structure, and a valve core connected to the valve nozzle. The valve nozzle is used to dock with the airflow suction device, and the valve core is used to open or close the first through hole.

5. The negative pressure adsorption hemostat according to claim 4, characterized in that, The bottom of the valve nozzle is provided with a second through hole. The valve core includes a base and a limiting part. The limiting part is connected to the base through a rod. The diameter of the rod is smaller than the diameter of the second through hole, and the diameter of the limiting part is larger than the diameter of the second through hole. The rod passes through the second through hole, and the limiting part is located in the valve nozzle. Based on the air pressure difference on both sides of the base, the base has a first state position with the first through hole closed and a second state position with the first through hole open.

6. The negative pressure adsorption hemostat according to claim 5, characterized in that, There is a gap between the valve nozzle and the bottom wall of the receiving groove, the base is located in the gap, and the valve core can move in the valve core so that the base is in the first state position or the second state position.

7. The negative pressure adsorption hemostat according to claim 6, characterized in that, A window is also provided on the side wall of the valve nozzle, and the gap communicates with the internal space of the valve nozzle through the window; so that when the base is in the second state, the airflow in the cavity enters the valve nozzle sequentially through the first through hole, the gap, and the window.

8. The negative pressure adsorption hemostat according to claim 4, characterized in that, The valve nozzle is also provided with an annular step for docking with the suction device.

9. The negative pressure adsorption hemostat according to claim 1, characterized in that, It also includes a fixing part connected to the housing, the fixing part being used to fix the main body to the target part of the skin.

10. The negative pressure adsorption hemostat according to claim 9, characterized in that, The fixing part includes flexible strips connected to opposite sides of the housing, and the free ends of the two flexible strips are detachably connected.

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