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CN104224268B - Hemostasis vacuum equipment and hemostasis vacuum scalpel - Google Patents

Hemostasis vacuum equipment and hemostasis vacuum scalpel Download PDF

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Publication number
CN104224268B
CN104224268B CN201310234910.1A CN201310234910A CN104224268B CN 104224268 B CN104224268 B CN 104224268B CN 201310234910 A CN201310234910 A CN 201310234910A CN 104224268 B CN104224268 B CN 104224268B
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vacuum
hemostatic
semi
blood
hemostasis
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CN104224268A (en
Inventor
刘恺鹏
龚祖光
范婷
刘军钪
刘杰
白峰
吴平凡
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3M Innovative Properties Co
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3M Innovative Properties Co
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61M1/0023
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention provides hemostasis vacuum equipment and hemostasis vacuum scalpel.Described hemostasis vacuum equipment includes: device for vacuum generation;One end is connected to the attachment means of device for vacuum generation;Semipermeable membrane, described semipermeable membrane has stop platelet and/or hemocyte the hole making hydrone pass through, the other end of described attachment means is connected to described semipermeable membrane, for making described hemostasis vacuum equipment can pass through the moisture in the blood at the absorption bleeding part, hole of described semipermeable membrane, thus play the effect accelerating hemostasis.

Description

Hemostasis vacuum device and hemostasis vacuum scalpel
Technical Field
The present invention relates to the field of medical devices, and in particular to a hemostatic vacuum device and a hemostatic vacuum scalpel for stopping bleeding during surgery.
Background
Typically, hemostasis is the first step in wound management. Hemostasis is a particularly important step, especially in surgery.
At present, several hemostasis methods mainly exist in the operation, which are a hemostat hemostasis method, a suture blood vessel hemostasis method and an electrotome hemostasis method respectively. Most of the existing hemostatic agents are derived from biological sources, such as collagen (gelatin or collagen), cellulose, chitosan, starch, fibrin, etc., which may present potential risks of causing irritation, allergy and inflammation to the human body. Sutured vascular hemostasis is commonly used to treat relatively large blood vessels and is difficult to apply to capillary hemostasis. Electrosurgical hemostasis is commonly used to sinter tissue at bleeding sites, but the sintered tissue may present the potential risk of weak scabbing, unstable clotting, and potentially causing secondary bleeding after surgery. Therefore, there is a need to develop a hemostatic device that can help doctors to stop bleeding quickly and stabilize blood coagulation during surgery.
Disclosure of Invention
An object of the present invention is to solve at least one of the above problems and disadvantages in the prior art.
The invention aims to solve the technical problem of rapidly stopping bleeding in a surgical operation and reducing the risk of secondary bleeding compared with the existing surgical electrotome.
By adopting the inventive concept of selective absorption, the hemostatic vacuum device of the present invention, used as a medical device, is placed over a bleeding site to increase the concentration of platelets in the vicinity of the bleeding site, thereby accelerating the natural clotting process. Specifically, the structure of the hemostasis vacuum device comprises a vacuum generating device, a connecting device and a semi-permeable membrane.
According to one aspect of the present invention, there is provided a hemostatic vacuum device, wherein the hemostatic vacuum device comprises:
a vacuum generating device;
a connecting device, one end of which is connected to the vacuum generating device; and
the semi-permeable membrane, the semi-permeable membrane has the hole that blocks platelet and/or blood cell and make the water molecule pass through, connecting device's the other end is connected to the semi-permeable membrane is used for making hemostasis vacuum device can see through the hole of semi-permeable membrane absorbs the moisture in the blood of bleeding position department to play the effect of accelerating hemostasis.
According to another aspect of the present invention, there is provided a hemostatic vacuum device, wherein the hemostatic vacuum device comprises:
a vacuum generating device;
a connecting device, one end of which is connected to the vacuum generating device; and
a hemostatic bag connected to the other end of the connecting device,
wherein,
the hemostasis package is provided with the pellicle, the pellicle has the hole that blocks platelet and blood cell and make the hydrone pass through, is used for making hemostasis vacuum device can see through the moisture in the blood of bleeding position department is absorb to the hole of pellicle to play hemostatic effect with higher speed.
In one example, the hemostatic vacuum device is tubular or knife-like in shape.
According to another aspect of the present invention, there is provided a hemostatic vacuum scalpel, wherein the hemostatic vacuum scalpel comprises a semi-permeable tip made of a semi-permeable membrane having pores blocking platelets and/or blood cells and passing water molecules.
The hemostasis vacuum device and the hemostasis vacuum scalpel provided by the invention have the following advantages: (1) the process of natural blood coagulation is accelerated, the blood coagulation is stable, and the risk of secondary bleeding is reduced; (2) the hemostatic bag is suitable for hemostasis of large-size bleeding areas; (3) adopts a unique selective absorption mechanism which is obviously different from the mechanism of the existing hemostatic product; and (4) convenient operation and use.
Drawings
These and/or other aspects and advantages of the present invention will become apparent and readily appreciated from the following description of certain preferred embodiments, taken in conjunction with the accompanying drawings of which:
FIG. 1 is a schematic illustration of a hemostatic vacuum device provided in accordance with certain preferred embodiments of the present invention;
FIG. 2 is a perspective view of a hemostatic vacuum device provided in accordance with certain preferred embodiments of the present invention;
FIG. 3 is a schematic view of a hemostatic bag in the hemostatic vacuum device of FIG. 2;
FIG. 4 is a schematic view of a portion of the semipermeable membrane of FIG. 1 under an electron microscope;
FIG. 5a is a schematic view of the hemostatic bag in the hemostatic vacuum device of FIGS. 2 and 3 and an enlarged view of the upper right corner thereof;
FIG. 5b is a side view of the hemostatic bag of FIG. 5 a;
FIG. 6a is a schematic representation of the result of a test of hemostatic effectiveness of a hemostatic vacuum device in a rabbit in vitro thromboelastography test (before negative pressure aspiration) provided in accordance with certain preferred embodiments of the present invention; a
FIG. 6b is a schematic illustration of the result of a test of hemostatic effectiveness of a hemostatic vacuum device in a rabbit in vitro thromboelastography test (after negative pressure aspiration) provided in accordance with certain preferred embodiments of the present invention;
FIG. 7 is a graph comparing the results of a hemostatic effect test of a hemostatic vacuum scalpel provided according to certain preferred embodiments of the present invention with ordinary gauze in a rabbit in vivo femoral artery incision test;
FIG. 8 is a schematic view of a hemostatic vacuum surgical knife provided in accordance with certain preferred embodiments of the present invention in use; and
fig. 9 is a schematic view of a hemostatic vacuum surgical knife provided in accordance with certain preferred embodiments of the present invention.
Detailed Description
The technical scheme of the invention is further specifically described by the following embodiments and the accompanying drawings. In the specification, the same or similar reference numerals denote the same or similar components. The following description of the embodiments of the present invention with reference to the accompanying drawings is intended to explain the general inventive concept of the present invention and should not be construed as limiting the invention.
Unless otherwise indicated, all numbers expressing feature sizes, quantities, and physical characteristics used in the specification and claims are to be understood as being modified in all instances by the term "about". Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can be suitably varied by those skilled in the art in seeking to obtain the desired properties utilizing the teachings disclosed herein. The use of numerical ranges by endpoints includes all numbers within that range and any range within that range, for example, 1 to 5 includes 1, 1.1, 1.3, 1.5, 2, 2.75, 3, 3.80, 4, and 5, and the like.
Hemostasis vacuum device
The structure and the action principle of the hemostasis vacuum device provided by the invention are explained in detail in the following with reference to the attached drawings.
Referring to fig. 1 and 4, in accordance with certain preferred embodiments of the present invention, a hemostatic vacuum device 100 is provided that basically comprises the following components: a vacuum generating device 8; a connecting device 9, one end of the connecting device 9 is connected to the vacuum generating device 8; a semi-permeable membrane (SPM)1, said semi-permeable membrane 1 being connected to the other end of said connection means 9, said semi-permeable membrane 1 having an aperture 7 blocking the platelets 4 and/or the blood cells 3 and allowing the passage of water molecules 5.
Will the department of bleeding 6 is placed to pellicle 1 of hemostasis vacuum device 100, and the water molecule 5 in the blood is through the hole 7 of pellicle 1 is attracted by hemostasis vacuum device 100 negative pressure, and platelet 4 and/or blood cell 3 in the blood are blockked at the one side that pellicle 1 is close to bleeding 6 by pellicle 1, and consequently, pellicle 1 has improved the concentration of platelet 4 and/or blood cell 3 of bleeding 6 department to the blood coagulation process of bleeding 6 has been accelerated, has played the effect of accelerating the hemostasis.
Referring to fig. 2, in accordance with certain preferred embodiments of the present invention, the hemostatic vacuum device 100 provided by the present invention consists essentially of the following components: a vacuum generating device 8; a connecting device 9, one end of the connecting device 9 is connected to the vacuum generating device 8; a haemostatic bag 10, said haemostatic bag 10 being connected to said connection means 9; wherein the hemostatic bag 10 is provided with a semi-permeable membrane 1, the semi-permeable membrane 1 having pores 7 blocking platelets and blood cells and passing water molecules.
According to certain preferred embodiments of the present invention, the hemostatic bag 10 may further include a water-absorbent material 2, and the water-absorbent material 2 is disposed on the opposite side of the semipermeable membrane 1 from the side where platelets and/or blood cells are blocked.
Will the hemostasis package 10 of hemostasis vacuum device 100 is placed bleeding position 6 department, and the water molecule 5 in the blood is through the hole 7 of the pellicle 1 on hemostasis package 10 is attracted by hemostasis vacuum device 100 negative pressure, and the platelet 4 and/or the blood cell 3 in the blood are blockked at the pellicle 1 and are close to bleeding position 6 one side by pellicle 1, consequently, the pellicle 1 has improved the concentration of the platelet 4 and/or the blood cell 3 of bleeding position 6 department to the blood coagulation process of bleeding position 6 has been accelerated, has played the effect of accelerating hemostasis.
According to certain preferred embodiments of the present invention, the connection means 9 may be any connection means such as can be adapted to connect to the vacuum generating means 8, preferably but not limited to a suction tube.
According to certain preferred embodiments of the present invention, the vacuum generating device 8 may be a suitable vacuum source such as a portable pump, a wall suction device or a negative pressure generating device.
According to certain preferred embodiments of the present invention, referring to fig. 2, the interface of the hemostatic bag 10 and the connection device 9 may be covered with a polyurethane dressing (e.g., such asDressing) 11 is sealed.
According to certain preferred embodiments of the present invention, referring to fig. 2, a one-way valve 32 may be provided between the hemostatic bag 10 and the suction tube 9 to prevent backflow.
As shown in fig. 2, the hemostatic vacuum device 100 may be made portable to fit a variety of applications both inside and outside of a hospital, such as operating rooms, battlefields, outdoor activity areas, home care, and the like.
According to certain preferred embodiments of the present invention, as shown in fig. 5a and 5b, the semipermeable membrane 1 may be provided in the form of a layer or a mat, and the water-absorbent substance 2 may be provided in the form of a mat or a layer, or may be provided in the form of powder, particles, or fibers.
According to certain preferred embodiments of the present invention, the hemostatic bag 10 may include two semi-permeable film layers having pores 7 that block platelets 4 and/or blood cells 3 and allow water molecules 5 to pass through; the water-absorbing substance 2 (e.g., the water-absorbing substance 2 may be provided in the form of a pad or layer) is sandwiched between two semi-permeable membrane layers for drawing water from the blood at the bleeding site 6 through the pores 7 of the semi-permeable membrane layers, thereby serving to accelerate hemostasis.
According to certain preferred embodiments of the present invention, the hemostatic bag 10 may include a semi-permeable membrane layer having pores that block platelets 4 and/or blood cells 3 and allow water molecules 5 to pass through; the water-absorbent substance 2 (for example, the water-absorbent substance 2 may be provided in the form of a pad or a layer) is sandwiched in the middle of the semipermeable membrane layer or at the center of the semipermeable membrane layer (for example, the water-absorbent substance may be provided in the middle of the folded semipermeable membrane layer or at the center of the semipermeable membrane layer) for sucking water in blood at the bleeding site 6 through the pores 7 of the semipermeable membrane layer, thereby functioning to accelerate hemostasis.
According to certain preferred embodiments of the present invention, as shown in fig. 4, the semi-permeable membrane 1 may include one or more holes 7 arranged regularly or irregularly, the holes 7 having a pore size to block platelets and/or blood cells and allow water molecules to pass through. The platelets and/or blood cells can be human platelets and/or blood cells, or platelets and/or blood cells of other animals. The semi-permeable membrane 1 or the hemostatic vacuum device comprising the semi-permeable membrane 1 may be applied to the hemostasis process of humans or other different animals by selecting the pore size of the pores 7 of the different semi-permeable membranes 1.
According to certain preferred embodiments of the present invention, the semipermeable membrane 1 may be any membrane material having suitable semipermeable properties of pores, any woven or non-woven material having suitable pores, preferably a medical membrane material having suitable semipermeable properties of pores, a woven or non-woven medical material having suitable pores. According to certain preferred embodiments of the present invention, the pores 7 of the semi-permeable membrane 1 have a pore size of 0.01 to 15 μm, for example the pore size may be 1 μm, 5 μm or 11 μm. Since the diameter of each blood cell 3 (e.g., red blood cell, white blood cell) in the human blood is about 8-12 μm, the diameter of the platelet 4 is about 5-8 μm, and the diameter of the water molecule is about 0.4nm, the water molecules 5 in the human blood are absorbed by the water-absorbent material 2 through the pores 7 of the semipermeable membrane 1, and the platelet 4 and/or the blood cell 3 in the blood are blocked by the semipermeable membrane 1 on the side of the semipermeable membrane 1 near the bleeding site 6.
According to certain preferred embodiments of the present invention, the semipermeable membrane 1 may be a semipermeable membrane available from Sefar corporation, which is made of nylon, and the pores 7 have a pore size of 1 μm, 5 μm, or 11 μm.
In accordance with certain preferred embodiments of the present invention, the hemostatic bag 10 may be square, rectangular, rod-shaped, or cone-shaped for the purpose of facilitating hemostasis. When the hemostatic bag 10 is square or rectangular, the length of the hemostatic bag 10 may be 1-20cm, and the width of the hemostatic bag 10 may be 1-20 cm. When the hemostatic bag 10 is rod-shaped or cone-shaped, one skilled in the art can select a suitable size as desired.
According to certain preferred embodiments of the present invention, as shown in FIGS. 5a and 5b, the hemostatic bag 10 may be formed to have a length of 3 × 3cm2Is placed in the middle or center of the semipermeable membrane 1, and the edges of the semipermeable membrane 1 are sealed firmly (e.g., heat-sealed) to prevent the water-absorbent substance 2 in the hemostatic bag 10 from leaking out or being contaminated.
According to certain preferred embodiments of the present invention, the water-absorbent material 2 may be any suitable water-absorbent material. The water-absorbent material 2 is preferably a superabsorbent polymer. The superabsorbent polymer may be selected from one or a combination of the following: starch-based polymers, cellulose-based polymers, and synthetic polymer-based polymers. According to certain preferred embodiments of the present invention, the water-absorbent material 2 in the hemostatic bag may be selected from super absorbent polymer powders whose main component is polyacrylic acid.
The hemostasis vacuum device provided by the invention at least has the following advantages: (1) the material used in the invention, especially the semipermeable membrane directly contacting with the wound is an artificially synthesized high molecular substance, but not a substance extracted from an organism, thereby reducing the risks of sensitization and stimulation in the hemostasis process; (2) the hemostatic performance is good, and the hemostatic process is stable; (3) the unique selective absorption mechanism is adopted, so that the mechanism is obviously different from that of the existing hemostatic product; and (4) convenient operation and use.
Hemostatic vacuum scalpel
Referring to fig. 1, 4, 8 and 9, according to certain preferred embodiments provided by the present invention, the present invention also provides a hemostatic vacuum surgical knife 200, the hemostatic vacuum surgical knife 200 including a semi-permeable tip 20, the semi-permeable tip 20 being made of a semi-permeable membrane 1, the semi-permeable membrane 1 having an aperture 7 blocking platelets and/or blood cells and allowing water molecules to pass therethrough.
According to certain preferred embodiments provided herein, the hemostatic vacuum surgical device 200 may further comprise: a connection device 9, one end of the connection device 9 is connected to the vacuum generating device 8, and the other end of the connection device 9 is connected to the semi-permeable tip 20, so that the hemostasis vacuum surgery device 200 can suck the moisture in the blood at the bleeding site 6 through the hole 7 of the semi-permeable tip 20, thereby playing a role of accelerating hemostasis.
According to certain preferred embodiments of the present invention, the hemostatic vacuum surgical device 200 may further include a water-absorbent material 2, and the water-absorbent material 2 may be disposed on the opposite side of the platelet and/or blood cell blocking side of the semi-permeable tip 20 for further absorbing water in blood at the bleeding site 6 through the hole 7 of the semi-permeable tip 20.
According to certain preferred embodiments of the present invention, as shown in fig. 4, the semi-permeable membrane 1 may include one or more holes 7 arranged regularly or irregularly, the holes 7 having a pore size to block platelets and/or blood cells and allow water molecules to pass through. The platelets and/or blood cells can be human platelets and/or blood cells, or platelets and/or blood cells of other animals. The semi-permeable membrane 1 or the hemostatic vacuum scalpel comprising the semi-permeable membrane 1 can be applied to the hemostatic process of human beings or other different animals by selecting the pore size of the pores 7 of the semi-permeable membrane 1.
According to certain preferred embodiments of the present invention, the semipermeable membrane 1 may be any membrane material having suitable semipermeable properties of pores, any woven or non-woven material having suitable pores, preferably a medical membrane material having suitable semipermeable properties of pores, a woven or non-woven medical material having suitable pores. According to certain preferred embodiments of the present invention, the pores 7 of the semi-permeable membrane 1 have a pore size of 0.01 to 15 μm, for example the pore size may be 1 μm, 5 μm or 11 μm. Since the diameter of each blood cell 3 (e.g., red blood cell, white blood cell) in the human blood is about 8-12 μm, the diameter of the platelet 4 is about 5-8 μm, and the diameter of the water molecule is about 0.4nm, the water molecules 5 in the human blood are absorbed by the water-absorbent material 2 through the pores 7 of the semipermeable membrane 1, and the platelet 4 and/or the blood cell 3 in the blood are blocked by the semipermeable membrane 1 on the side of the semipermeable membrane 1 near the bleeding site 6.
According to certain preferred embodiments of the present invention, the semipermeable membrane 1 may be a semipermeable membrane available from Sefar corporation, which is made of nylon, and the pores 7 have a pore size of 1 μm, 5 μm, or 11 μm.
According to certain preferred embodiments of the present invention, the water-absorbent material 2 may be any suitable water-absorbent material. The water-absorbent material 2 is preferably a superabsorbent polymer. The superabsorbent polymer may be selected from one or a combination of the following: starch-based polymers, cellulose-based polymers, and synthetic polymer-based polymers. According to certain preferred embodiments of the present invention, the water-absorbent material 2 in the hemostatic bag may be selected from super absorbent polymer powders whose main component is polyacrylic acid.
The hemostasis vacuum scalpel has at least the following advantages: (1) the material used in the invention, especially the semipermeable membrane directly contacting with the wound is an artificially synthesized high molecular substance, but not a substance extracted from an organism, thereby reducing the risks of sensitization and stimulation in the hemostasis process; (2) the hemostatic performance is good, and the hemostatic process is stable; (3) the unique selective absorption mechanism is adopted, so that the mechanism is obviously different from that of the existing hemostatic product; and (4) convenient operation and use.
Examples
The hemostatic performance of the hemostatic vacuum device provided by the present invention is evaluated by in vitro rabbit thromboelastography (the platelets and/or blood cells in rabbit blood are similar to or slightly smaller than those in human blood) in the following examples.
Example 1
In the test, the rabbit in vitro thrombelastogram test is mainly carried out by using a thrombelastogram instrument and rabbit whole blood, and the thrombelastogram instrument can adopt a TEG5000 type thrombelastogram instrument produced by American blood technology company.
In this test, the hemostatic vacuum device provided by the present invention comprises a vacuum generating device, a connecting device and a semi-permeable membrane. The vacuum generating device is a portable sputum aspirator (model 7E-A/B) manufactured by Jiangsu Yunjiao medical equipment Limited, and can provide negative pressure with the vacuum degree of 0.01 Mpa. The connecting device is the suction tube of the portable sputum aspirator, and the semipermeable membrane is coated at the tip end of the suction tube. The semipermeable membrane can be made of nylon with a pore size of 1 μm.
The rabbit in-vitro thrombelastogram test comprises the following specific steps:
1) placing fresh rabbit whole blood in an anticoagulation tube of a thromboelastogram instrument;
2) collecting a first rabbit whole blood sample in an anticoagulation tube by using a thromboelastography instrument, and testing the coagulation curve of the first sample;
3) after the tip of a suction tube of the portable sputum aspirator is coated with a semipermeable membrane, the tip is stretched into fresh rabbit whole blood of an anticoagulation tube of a thromboelastogram instrument, and the rabbit whole blood is sucked for 5 seconds by using negative pressure of 0.01 MPa;
4) collecting a second rabbit whole blood sample in an anticoagulation tube by using a thromboelastography instrument, and testing a coagulation curve of the second rabbit whole blood sample subjected to negative pressure suction;
5) the coagulation curves of the first rabbit whole blood sample and the second rabbit whole blood sample were compared and the results are shown in fig. 6a, fig. 6b and table 1.
TABLE 1 rabbit in vitro thrombelastogram test
First rabbit whole blood sample Second rabbit Whole blood sample
R(min) 5.5 4.9
Angle(deg) 72.6 77.9
MA(mm) 72.1 76.8
Note: in thromboelastography, the horizontal axis represents time and the vertical axis represents trace amplitude.
R represents the time (min) required from the start of the blood sample collection by the thromboelastography in the anticoagulation tube until the start of the fibrin clot formation in the blood sample, and is used to characterize the time at which the clot formation in the blood sample starts;
angle represents an included Angle formed by drawing a tangent line and a horizontal line from a blood clot forming point in a blood sample to the maximum curve radian of a thromboelastogram, and is used for representing the rate of blood clot formation in the blood sample, wherein the larger the included Angle is, the faster the rate of blood clot formation in the blood sample is;
MA represents the maximum amplitude of the trace amplitude on the thromboelastogram, which characterizes the maximum intensity of a blood clot in a blood sample, the higher the value the higher the intensity of clotting of the blood clot in the blood sample.
As shown in FIG. 6a, FIG. 6b and Table 1, after the negative pressure suction, the R value was reduced from 5.5min to 4.9min, the Angle value was increased from 72.6deg to 77.9deg, and the MA value was increased from 72.1mm to 76.8 mm. These results all show that after negative pressure suction, the semipermeable membrane in the hemostasis vacuum device provided by the invention can allow water molecules in blood to pass through the holes of the semipermeable membrane and block platelets and/or blood cells from passing through, so that the concentration of the platelets and/or blood cells at the bleeding part is increased, the coagulation rate is increased, the strength of blood clots is increased, and the hemostasis process is accelerated.
The hemostatic performance of the hemostatic vacuum scalpel provided by the present invention is evaluated by a rabbit in vivo femoral artery incision test (platelets and/or blood cells in rabbit blood are similar to or slightly smaller than those in human blood) in the form of an example.
Example 2
Placing a rabbit weighing about 2kg on the back on an operating table, and separating two rear legs; the skin of the rabbit was cut and the muscles were dissected to expose and isolate the femoral artery; using surgical scissors, the femoral artery was cut to produce bleeding (the cut wound was approximately one-third the thickness of the femoral artery). The semi-permeable tip of the hemostatic vacuum scalpel provided by the present invention was placed at the wound site and a force of a 50g weight (approximately 0.49 newtons) was applied. The semi-permeable tip is made by the pellicle, the pellicle is the pellicle of the material for nylon of purchasing from the Sefar company, the hole of pellicle is regularly arranged, the diameter of the hole of pellicle is 1 mu m. The hemostasis vacuum scalpel comprises a suction tube, one end of the suction tube is connected to a vacuum generating device, the other end of the suction tube is connected to the semi-permeable tip, the length of the suction tube is about 400mm, and the diameter of the suction tube is about 4 mm. The vacuum generating device is a portable sputum aspirator (model 7E-A/B) manufactured by Jiangsu Yunjiao medical equipment Limited, and can provide negative pressure with the vacuum degree of 0.01 Mpa.
Every 5 minutes, the wound site was observed by the human eye for bleeding that remained ruptured. The hemostasis time was measured and calculated using a stopwatch, with the time the semi-permeable tip of the hemostasis vacuum scalpel was placed into the wound site as the start time and the time the human eye observed the bleeding stopped as the end time:
hemostasis time-end time-start time
The test results are shown in Table 2 and FIG. 7, each test result being an average of the hemostatic time of six tests.
Example 3
The rabbit in vivo femoral artery incision test was performed in the same manner as in example 2, except that the diameter of the pores of the semipermeable membrane was 5 μm.
The test results are shown in Table 2 and FIG. 7, each test result being an average of the hemostatic time of six tests.
Comparative example 1
Placing a rabbit weighing about 2kg on the back on an operating table, and separating two rear legs; the skin of the rabbit was cut and the muscles were dissected to expose and isolate the femoral artery; using surgical scissors, the femoral artery was cut to produce bleeding (the cut wound was approximately one-third the thickness of the vessel).
Ordinary gauze may be placed and secured to the wound site by applying a 50g weight (approximately 0.49 newtons) to the ordinary gauze. The common gauze is absorbent cotton gauze purchased from Haimaolong medical supplies and equipment Co.
Every 5 minutes, the plain gauze was removed and the wound site was checked for bleeding still ruptured. The hemostasis time was measured and calculated with a stopwatch, with the time of placing ordinary gauze as the start time and the time of observing the cessation of bleeding by the human eye as the end time:
hemostasis time-end time-start time
The test results are shown in Table 2 and FIG. 7, each test result being an average of the hemostatic time of six tests.
TABLE 2 Rabbit in vivo femoral artery incision test
As can be seen from table 2 and fig. 7, in the rabbit in-vivo femoral artery incision test, the hemostatic time using the hemostatic vacuum scalpel provided by the present invention is much shorter than that using ordinary gauze, so the hemostatic vacuum scalpel provided by the present invention has better hemostatic performance than ordinary gauze. In addition, as the aperture size of the hole of the semi-permeable tip (semi-permeable membrane) of the hemostasis vacuum scalpel is decreased progressively (5 μm, 1 μm), the hemostasis time is also shortened, which shows that in a certain aperture range, the semi-permeable membrane with the hole with the smaller aperture size can better prevent the passage of blood platelets and blood cells, the concentration effect of blood is better, and the hemostasis vacuum scalpel with the semi-permeable membrane with the hole with the smaller aperture size also has better hemostasis effect.
Although the present invention has been described in connection with the accompanying drawings, the embodiments disclosed in the drawings are intended to be illustrative of preferred embodiments of the present invention and should not be construed as limiting the invention.
Although a few embodiments of the present general inventive concept have been shown and described, it would be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the general inventive concept, the scope of which is defined in the claims and their equivalents.

Claims (19)

1. A hemostatic vacuum device, wherein the hemostatic vacuum device comprises:
a vacuum generating device;
a connecting device, one end of which is connected to the vacuum generating device; and
the semi-permeable membrane, the semi-permeable membrane has the hole that blocks platelet and/or blood cell and make the water molecule pass through, connecting device's the other end is connected to the semi-permeable membrane is used for making hemostasis vacuum device can see through the hole of semi-permeable membrane absorbs the moisture in the blood of bleeding position department to play the effect of accelerating hemostasis.
2. A hemostatic vacuum device, wherein the hemostatic vacuum device comprises:
a vacuum generating device;
a connecting device, one end of which is connected to the vacuum generating device; and
a hemostatic bag connected to the other end of the connecting device,
wherein,
the hemostasis package is provided with the pellicle, the pellicle has the hole that blocks platelet and blood cell and make the hydrone pass through, is used for making hemostasis vacuum device can see through the moisture in the blood of bleeding position department is absorb to the hole of pellicle to play hemostatic effect with higher speed.
3. A haemostatic vacuum device according to claim 1 or 2, wherein the pores of the semi-permeable membrane have a pore size of 0.01-15 μm.
4. A haemostatic vacuum device according to claim 1 or 2, wherein the semi-permeable membrane is a medical woven membrane or a medical non-woven membrane material having semi-permeable properties.
5. A haemostatic vacuum device according to claim 2, wherein the haemostatic bag further comprises a water-absorbent substance arranged on the opposite side of the semi-permeable membrane that blocks platelets and/or blood cells for further drawing moisture from the blood at the bleeding site through the pores of the semi-permeable membrane.
6. A hemostatic vacuum device according to claim 2, wherein the hemostatic bag further comprises a water absorbent substance wrapped within a semi-permeable membrane for further drawing moisture from blood at a hemorrhage site through the pores of the semi-permeable membrane.
7. The hemostatic vacuum device according to claim 2, wherein the hemostatic bag comprises: the blood absorbing material is clamped at the center of the semipermeable membrane layer or in the middle of the semipermeable membrane layer and is used for further absorbing water in blood at the bleeding part through the holes of the semipermeable membrane layer.
8. A haemostatic vacuum device according to any of claims 5, 6 or 7, wherein the water-absorbing substance is provided in the form of a powder, granules, fibres, mat or layer in a haemostatic bag.
9. A haemostatic vacuum device according to any of claims 5, 6 or 7, wherein the water-absorbing substance is a super-absorbent polymer selected from one or more of the following: starch-based polymers, cellulose-based polymers, and synthetic polymer-based polymers.
10. A haemostatic vacuum device according to claim 2, wherein the haemostatic bag is rod-shaped, cone-shaped, square-shaped or rectangular and has a length of 1-20cm and a width of 1-20 cm.
11. The hemostatic vacuum device of claim 2, wherein the edges of the hemostatic bag are sealed securely such that the substance within the hemostatic bag is sealed within the hemostatic bag.
12. A haemostatic vacuum device according to claim 1 or 2, wherein the vacuum generating device is a portable pump, a hospital wall suction device or a negative pressure generating device.
13. A haemostatic vacuum device according to claim 1 or 2, wherein the connecting means is a suction tube.
14. A haemostatic vacuum device according to claim 1 or 2, wherein the haemostatic vacuum device is tubular or knife-like in shape.
15. A hemostatic vacuum scalpel wherein the hemostatic vacuum scalpel comprises a semi-permeable tip made of a semi-permeable membrane with holes that block platelets and/or blood cells and let water molecules pass through.
16. The hemostatic vacuum surgical knife of claim 15, further comprising: the connecting device, the one end of connecting device is connected to the vacuum and produces the device, the other end of connecting device is connected to the semi-permeable point is used for making hemostasis vacuum scalpel can permeate through the hole of semi-permeable membrane absorbs the moisture in the blood of bleeding position department to play the effect of accelerating hemostasis.
17. The hemostatic vacuum surgical knife of claim 15 further comprising a water absorbent material disposed on an opposite side of the semipermeable tip from the side that blocks platelets and/or blood cells for further drawing moisture from blood at a hemorrhage site through the pores of the semipermeable membrane.
18. The hemostatic vacuum surgical knife of any one of claims 15-17 wherein the pores of the semi-permeable membrane have a pore size of 0.01-15 μ ι η.
19. The hemostatic vacuum surgical knife according to any one of claims 15-17, wherein the semi-permeable membrane is a medical woven membrane or a medical non-woven membrane material having semi-permeable properties.
CN201310234910.1A 2013-06-14 2013-06-14 Hemostasis vacuum equipment and hemostasis vacuum scalpel Expired - Fee Related CN104224268B (en)

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