CN111166411A - Uterine tamponade hemostatic balloon and use method thereof - Google Patents
Uterine tamponade hemostatic balloon and use method thereof Download PDFInfo
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- CN111166411A CN111166411A CN201911369306.3A CN201911369306A CN111166411A CN 111166411 A CN111166411 A CN 111166411A CN 201911369306 A CN201911369306 A CN 201911369306A CN 111166411 A CN111166411 A CN 111166411A
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- 238000000034 method Methods 0.000 title claims abstract description 37
- 230000002439 hemostatic effect Effects 0.000 title claims abstract description 36
- 210000004291 uterus Anatomy 0.000 claims abstract description 79
- 208000032843 Hemorrhage Diseases 0.000 claims abstract description 48
- 230000000740 bleeding effect Effects 0.000 claims abstract description 47
- 210000002826 placenta Anatomy 0.000 claims abstract description 20
- 208000036029 Uterine contractions during pregnancy Diseases 0.000 claims abstract description 16
- 239000002775 capsule Substances 0.000 claims abstract description 13
- 206010046788 Uterine haemorrhage Diseases 0.000 claims abstract description 12
- 210000005077 saccule Anatomy 0.000 claims abstract description 11
- 239000002504 physiological saline solution Substances 0.000 claims abstract description 10
- 208000034423 Delivery Diseases 0.000 claims abstract description 4
- 230000009677 vaginal delivery Effects 0.000 claims abstract description 4
- 230000008602 contraction Effects 0.000 claims description 33
- 230000006835 compression Effects 0.000 claims description 22
- 238000007906 compression Methods 0.000 claims description 22
- 238000012544 monitoring process Methods 0.000 claims description 21
- 239000007924 injection Substances 0.000 claims description 14
- 238000002347 injection Methods 0.000 claims description 14
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
- XNOPRXBHLZRZKH-UHFFFAOYSA-N Oxytocin Natural products N1C(=O)C(N)CSSCC(C(=O)N2C(CCC2)C(=O)NC(CC(C)C)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC(=O)C(C(C)CC)NC(=O)C1CC1=CC=C(O)C=C1 XNOPRXBHLZRZKH-UHFFFAOYSA-N 0.000 claims description 9
- 101800000989 Oxytocin Proteins 0.000 claims description 9
- 102100031951 Oxytocin-neurophysin 1 Human genes 0.000 claims description 9
- XNOPRXBHLZRZKH-DSZYJQQASA-N oxytocin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSC[C@H](N)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)=O)[C@@H](C)CC)C1=CC=C(O)C=C1 XNOPRXBHLZRZKH-DSZYJQQASA-N 0.000 claims description 9
- 229960001723 oxytocin Drugs 0.000 claims description 9
- 238000003825 pressing Methods 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- 238000013459 approach Methods 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 238000003745 diagnosis Methods 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 208000007536 Thrombosis Diseases 0.000 claims description 3
- 206010046910 Vaginal haemorrhage Diseases 0.000 claims description 3
- 230000017531 blood circulation Effects 0.000 claims description 3
- 230000023555 blood coagulation Effects 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 3
- 230000002265 prevention Effects 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 208000034158 bleeding Diseases 0.000 description 34
- 208000018525 Postpartum Hemorrhage Diseases 0.000 description 7
- 230000000694 effects Effects 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 210000001015 abdomen Anatomy 0.000 description 3
- 230000023597 hemostasis Effects 0.000 description 3
- 210000000685 uterine artery Anatomy 0.000 description 3
- 208000010238 Uterine Inertia Diseases 0.000 description 2
- 206010046763 Uterine atony Diseases 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
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- 238000013461 design Methods 0.000 description 2
- 238000009802 hysterectomy Methods 0.000 description 2
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- 230000008569 process Effects 0.000 description 2
- 206010060964 Arterial haemorrhage Diseases 0.000 description 1
- 210000003815 abdominal wall Anatomy 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B2017/4216—Operations on uterus, e.g. endometrium
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Abstract
The invention belongs to the technical field of interventional medical instruments, and particularly relates to a uterine tamponade hemostatic balloon and a use method thereof; the uterus-filling hemostatic balloon comprises a balloon and a catheter group, wherein the balloon comprises a body cavity balloon and two uterine horn balloons, the uterine horn balloons are fixedly connected to the outer surface of the balloon, and the interiors of the uterine horn balloons and the body cavity balloon are not communicated; a method for using a uterine tamponade hemostatic balloon, characterized in that: the method comprises the following steps: step A, after the vaginal delivery placenta is delivered, checking the bleeding condition, and judging the bleeding part of the uterus; b, the uterus is filled with a hemostatic balloon and sent into the uterine cavity through the cervical orifice; step C, connecting the drainage bag to the lower end of the drainage tube, and recording the uterine bleeding amount at regular time; step D, injecting physiological saline into different capsule bodies according to the uterine bleeding part; step E, taking out the saccule after bleeding stops; the invention can solve the problem that no effective hemostatic measures exist in clinic for placenta adhesion and uterine contraction weakness caused by placenta adhesion to uterine horn at present.
Description
Technical Field
The invention belongs to the technical field of interventional medical instruments, and particularly relates to a uterine tamponade hemostatic balloon and a use method thereof.
Background
In clinic, a puerpera with placenta attached to uterine horn often encounters high bleeding amount due to poor postpartum uterine contraction, especially poor uterine horn contraction force, and is open to the abdomen and sews up the uterus, even the uterus is cut off. At present, no effective hemostatic measure exists clinically for placenta adhesion and uterine atony caused by placenta adhesion to uterine horn, and although a method for performing compression hemostasis on uterus by adopting a saccule (Bayri saccule) also exists in the prior art, the hemostatic method is mainly designed for lower uterine bleeding, and no effective treatment and hemostatic measure exists for uterine horn bleeding. When the placenta is attached to the uterine horn, placenta adhesion or placenta retention is easy to occur, and when the placenta is peeled off by hand or the uterus is scraped, the bleeding amount of the placenta attachment surface is large. Because the part has an angulation with the uterine cavity, the existing balloon can not effectively press the uterine horn part, has poor hemostatic effect and large postpartum hemorrhage amount, and is often required to open the abdomen and ligate the uterus or perform hysterectomy.
Disclosure of Invention
In view of the above, the present invention aims to provide a uterine tamponade hemostatic balloon and a method for using the same, so as to solve the problem that no effective hemostatic measure exists in clinical practice for placenta adhesion and uterine atony.
In order to achieve the purpose, the technical scheme of the invention is realized as follows:
a uterus tamponade hemostasis balloon comprises a balloon and a catheter group, wherein the balloon comprises a body cavity balloon and two uterine horn balloons, the uterine horn balloons are fixedly connected to the outer surface of the balloon, the interiors of the uterine horn balloons and the body cavity balloon are not communicated, and the two uterine horn balloons are respectively positioned at the upper left corner and the upper right corner of the body cavity balloon;
the catheter group comprises a main balloon catheter, side balloon catheters and a drainage tube, the main balloon catheter communicates the body cavity balloon with the liquid injection ports of the external injectors, the side balloon catheters communicate the two uterine horn balloons with the liquid injection ports of the external injectors respectively, the drainage tube penetrates through the body cavity balloon, the upper end of the drainage tube extends out of the body cavity balloon, and the lower end of the drainage tube is connected with a drainage bag.
further, the included angle of the central axes of the two uterine angle capsules 12 at the intersection point is α, and the range of the α angle is 90-120 °.
Further, the length of the upper end of the drainage tube extending out of the external part of the body cavity sac is 8-10 mm.
Furthermore, the catheter group also comprises an outer sleeve, the main balloon catheter, the side balloon catheter and the drainage tube are tightly wrapped by the outer sleeve to form an integral tube bundle structure, and the outer wall of the outer sleeve is fixedly connected with the body cavity balloon in a sealing way at the position where the catheter group penetrates into the body cavity balloon;
the upper end of the main balloon catheter is positioned in the body cavity balloon, the lower end of the main balloon catheter penetrates out of the body cavity balloon through the outer sleeve, a control valve is arranged near the outlet, the upper end of the side balloon catheter is branched into a first branch pipe and a second branch pipe, the upper ends of the first branch pipe and the second branch pipe penetrate through the wall of the body cavity balloon and extend into the uterine horn balloon to be communicated with the uterine horn balloon, the lower end of the side balloon catheter penetrates out of the body cavity balloon through the outer sleeve, and a control valve is arranged near the outlet; the drainage tube is provided with a control valve near the interface between the drainage tube and the drainage bag.
Furthermore, the lower part of the body cavity bag is provided with a concave part, and the surface of the concave part is provided with an antiskid bulge.
Furthermore, a bulge part is arranged at the top of the uterine horn bag.
The balloon further comprises a plurality of pressure sensors, wherein the plurality of pressure sensors are attached and installed at different positions on the surface of the balloon; wherein, two sides of the bulge of the uterine horn bag are respectively provided with a first pressing point, and each first pressing point is provided with a pressure sensor; two second compression points are symmetrically arranged at the lower part of the body cavity sac, and each second compression point is provided with a pressure sensor; the pressure sensor is communicated with a controller through communication signals, and the controller is electrically connected with an external display.
furthermore, the included angle of the vertical lines of the tangent lines of the two first compression points 41 at the uterine cavity capsule 12 at the intersection point is beta, the beta angle ranges from 70 degrees to 100 degrees, the included angle of the vertical lines of the tangent lines of the two second compression points 42 at the body cavity capsule 11 at the intersection point is gamma, and the gamma angle ranges from 90 degrees to 150 degrees.
Further, the pressure sensor is a flexible film pressure sensor.
A use method of a uterine tamponade hemostatic balloon comprises the following steps:
step A, after the vaginal delivery placenta is delivered, pressing the uterine fundus, knowing the height of the uterine fundus and the uterine contraction condition, checking and repairing the soft birth channel, checking the bleeding condition, and judging the uterine bleeding part;
b, the uterus is filled with a hemostatic balloon and sent into the uterine cavity through the cervical orifice;
step C, connecting the drainage bag to the lower end of the drainage tube, and recording the uterine bleeding amount at regular time;
step D, injecting physiological saline into different capsule bodies according to the uterine bleeding part;
and E, monitoring the uterine bleeding condition at any time after the balloon is placed, and taking out the balloon after bleeding stops.
Further, in the step B, when the uterus is packed with the hemostatic balloon and sent into the uterine cavity through the cervical orifice, the balloon placement position needs to be ensured to be accurate, and the specific method comprises the following steps: slowly sending the saccule into the uterine cavity from the cervical orifice, and stopping pushing inwards when pushing resistance is sensed, namely the end part of the drainage tube is just abutted against the top of the uterus; meanwhile, the position of the balloon is checked to be accurate by matching with B-ultrasonic monitoring, and the position of the balloon is properly adjusted according to the result of the B-ultrasonic monitoring.
Further, in step D, the method for injecting saline into the different capsules comprises:
when the bleeding part is positioned at the lower uterine segment, injecting physiological saline into a body cavity sac through a main sac catheter by an injector, wherein the maximum injection amount is 800ml, firstly injecting 350-400 ml, monitoring the numerical value of a pressure sensor at a second compression point, namely uterine contraction force, stopping injecting water when the uterine contraction force reaches or approaches 150mmHg, and closing a control valve;
when the bleeding part is positioned at the uterine horn, firstly injecting normal saline into the body cavity sac according to the method in the method I, then injecting the normal saline into the uterine horn sac through a lateral sac catheter by an injector, wherein the maximum injection amount is 200ml, firstly injecting 50-100 ml, monitoring the numerical value of a pressure sensor at 4 first compression points, namely uterine horn contraction force, and when the uterine contraction force reaches or approaches 150mmHg, injecting 10-20 ml again as appropriate, stopping injecting water, and closing a control valve;
and thirdly, when bleeding prevention is needed after delivery, the operation method in the second method is adopted as a measure for preventing the bleeding after delivery.
Further, in the step E, the uterine bleeding condition is monitored in real time by using a numerical value fed back by a pressure sensor arranged on the surface of the balloon, the data is analyzed according to the numerical value of the sub-pressure at each point recorded in a display, namely the uterine contraction force and the uterine angle contraction force values at two sides, the uterine contraction force values at two sides are compared, the uterine contraction condition is analyzed through data monitoring, the dropping speed and the dosage of oxytocin are adjusted in time, the organism is waited to play the blood coagulation function of the organism to form thrombus, and the next diagnosis and treatment are guided; if the postpartum uterine contractility value is close to or reaches 350mmHg, if the vaginal bleeding is not much at the moment, the uterine contractility is good, and the oxytocin dropping speed can be adjusted to the conventional dosage; if the postpartum uterine contraction force value is far less than 350mmHg, the dripping speed or dosage of oxytocin is increased while the vaginal blood flow is observed.
According to the numerical value of the sub-pressure at each point recorded in the display, when the postpartum uterine contractility reaches 350-400mmHg, the uterine contractility is good, and the saccule can be withdrawn in combination with the actual postpartum hemorrhage.
Compared with the prior art, the invention has the following advantages:
the balloon presses the inner wall of the uterus, especially the lower uterus segment and the uterine horn by arranging the body cavity bag and the uterine horn bag, so that the spiral uterine artery is pressed, and when the pressure in the uterine cavity is greater than the pressure of the spiral uterine artery, the arterial bleeding is reduced until the uterine artery is stopped. In the same way, the uterine venous plexus is pressed to reduce bleeding. After the main sac of the saccule is injected with physiological saline, the saccule is expanded to press the uterine cavity, and the uterine contraction, the blood vessel closure and the bleeding reduction are caused by reflexibility. The problem of when the placenta attached to the uterine horn and arouse the great amount of bleeding of uterine horn department, current sacculus (Bayli sacculus) can not effectively oppress the uterine horn position, effectively stanchs is solved, avoided postpartum hemorrhage volume too much and avoided the condition of open abdomen ligature uterus or line hysterectomy.
And the compression mode can be flexibly selected according to the actual bleeding position, when the placenta is attached to the normal position and the postpartum hemorrhage occurs, the coelomic sac can be started to stop bleeding, if the placenta is attached to the uterine horn or the position close to the uterine horn, the coelomic sac and the uterine horn sac can be simultaneously started to stop bleeding by compression, and the method can also be applied to postpartum hemorrhage preventive use.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an embodiment of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:
FIG. 1 is a schematic external view of the present invention;
FIG. 2 is a schematic view of the distribution of the catheter set inside the balloon;
FIG. 3 is a schematic view of a catheter set;
FIG. 4 is a schematic structural view of a side-pocket catheter;
figure 5 is a schematic view of the placement of the balloon within the uterus;
fig. 6 is a schematic view of the placing position of the uterine horn sac at the uterine horn.
Description of reference numerals:
11-body cavity pocket; 111-a recess; 112-anti-skid protrusions; 12-uterine horn sac; 121-a boss; 2-a catheter set; 21-a main balloon catheter; 22-a lateral balloon catheter; 221-branch pipe one; 222-Branch pipe two; 23-a drainage tube; 231-a drainage bag; 24-outer sleeve; 25-a control valve; 3-uterus; 31-uterine horn; 32-uterine orifice; compression point No. 41-one; 42-pressure point two.
Detailed Description
It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.
The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.
As shown in fig. 1-6, a uterine tamponade hemostatic balloon, which comprises a balloon and a catheter group 2, wherein the balloon comprises a body cavity balloon 11 and two uterine horn balloons 12, the uterine horn balloons 12 are fixedly attached to the outer surface of the balloon, the interiors of the uterine horn balloons 12 and the body cavity balloon 11 are not communicated, and the two uterine horn balloons 12 are respectively positioned at the upper left corner and the upper right corner of the body cavity balloon 11;
the catheter group 2 comprises a main balloon catheter 21, side balloon catheters 22 and drainage tubes 23, the main balloon catheter 21 communicates the body cavity 11 with the liquid injection ports of external injectors, the side balloon catheters 22 communicate the two uterine horn balloons 12 with the liquid injection ports of the external injectors respectively, the drainage tubes 23 penetrate through the body cavity 11, the upper ends of the drainage tubes 23 extend out of the body cavity 11, and the lower ends of the drainage tubes 23 are connected with a drainage bag 231.
When the hemostatic balloon is used, normal saline can be respectively injected into/pumped out of the body cavity sac 11 and the two uterine horn sacs 12 through the main sac catheter 21 or the side sac catheter 22, the upper end of the drainage tube 23 is positioned in the uterine cavity and is used for guiding and leading out blood in the uterus 3 in time.
preferably, the included angle of the central axes of the two uterine horn capsules 12 at the intersection point is α, the α angle ranges from 90 ° to 120 °, theoretically, the postpartum uterine angle is 90 °, and nearly α is also 90 °, and in consideration of practical situations, such as poor postpartum uterine contraction, or poor contraction due to placenta attachment, the uterine angle can be enlarged, and the α angle is also increased, so the α angle range is set to 90 ° to 120 °.
Preferably, the length of the upper end of the drainage tube 23 extending out of the body cavity sac 11 is 8-10mm, the tail end of the drainage tube is provided with an opening for draining blood, the length of the exposed section is selected and considered in combination with the structure of the uterus 3, in order to ensure that the placement position of the balloon in the uterus 3 is accurate, when the balloon is placed in the uterus 3, the end part of the drainage tube 23 abuts against the top of the uterus 3, the body cavity sac 11 is just pressed on the lower section (easy-bleeding part) of the uterus 3, meanwhile, the two uterine horn sacs 12 are just positioned at the uterine horns 31, because the balloon placement is mainly operated by the tactile sensation of doctors, when the end part of the drainage tube 23 is just abutted against the top of the uterus 3, the balloon placement accurate signal can be used as.
Preferably, as shown in fig. 3, the catheter group 2 further includes an outer sleeve 24, the main balloon catheter 21, the side balloon catheter 22 and the drainage tube 23 are tightly wrapped by the outer sleeve 24 to form an integral tube bundle structure, the outer wall of the outer sleeve 24 is fixedly connected with the body cavity balloon 11 at the position where the catheter group 2 penetrates into the body cavity balloon 11 in a sealing manner, by the structural design, on one hand, the service life of the product is prolonged, and when the catheter group 2 penetrates into the body cavity balloon 11, the sealing and fixing point only exists at the joint of the outer sleeve 24 and the body cavity balloon 11, so that the risk of air leakage caused by the increase of joints due to the fact that a plurality of catheters penetrate into the cavity balloon positions respectively is avoided; on the other hand, the structure of the catheter group 2 is more stable, the position of each catheter in the body cavity bag 11 needs to be relatively fixed, the outer sleeve 24 is additionally arranged, the function of primary positioning is achieved on the catheter, and the failure of the balloon caused by pulling of the catheter by external force in the operation and use process is prevented.
The upper end of the main balloon catheter 21 is positioned in the body cavity balloon 11, the lower end of the main balloon catheter 21 penetrates out of the body cavity balloon 11 through the outer sleeve 24, a control valve 25 is arranged near the outlet, the upper end of the side balloon catheter 22 is branched into a branch pipe I221 and a branch pipe II 222, the upper ends of the branch pipe I221 and the branch pipe II 222 penetrate through the cavity wall of the body cavity balloon 11 and extend into the uterine horn balloon 12 to be communicated with the uterine horn balloon 12, the lower end of the side balloon catheter 22 penetrates out of the body cavity balloon 11 through the outer sleeve 24, and a control valve 25 is arranged near the outlet; the drainage tube 23 is provided with a control valve 25 near the interface with the drainage bag 231, and by this structural design, in addition to the fact that the interiors of the body cavity sac 11 and the uterine horn sac 12 are not communicated, the function of independently injecting/extracting physiological saline into/from the body cavity sac 11 and the uterine horn sac 12 can be realized, and the internal bleeding of the uterus 3 is independently drained through the drainage tube 23, and the independent control is realized through the control valves 25 which are respectively arranged.
Preferably, as shown in fig. 5, the cavity bag 11 is provided at a lower portion thereof with a recess 111, and a non-slip protrusion 112 is provided on a surface of the recess 111. In order to ensure that the body cavity bag 11 is stably installed in the uterus 3, therefore, the structure at the lower part of the body cavity bag 11 and the internal physiological structure of the uterus 3 at the uterine orifice 32 are provided with a circle of concave parts 111, after the bag is placed in the uterus 3, the concave parts 111 are about 2-3 cm away from the uterine orifice, and the surface of the concave parts 111 is provided with anti-skid protrusions 112 which are transversely distributed on the surface of the body cavity bag 11 in a belt shape and have the width of about 1-1.5 cm, so that the friction force between the body cavity bag 11 and the wall of the uterus 3 is increased, and the body cavity bag 11 is prevented from sliding downwards.
Preferably, as shown in fig. 6, a convex portion 121 is provided on the top of the uterine horn capsule 12; due to the physiological structure, if the uterine horn bag 12 adopts a spherical structure, the top of the uterine horn bag 12 can not be completely attached to the uterine horn 31 of the uterus 3, and the compression hemostasis effect is not obvious, so the protrusion 121 arranged on the top of the uterine horn bag 12 can ensure that the uterine horn bag 12 is tightly attached to the inner wall of the uterine horn 31 after being completely unfolded, and the compression effect is effectively achieved.
Preferably, as shown in fig. 5, the balloon further comprises a plurality of pressure sensors, wherein the plurality of pressure sensors are attached and installed at different positions on the surface of the balloon; wherein, two sides of the convex part 121 of the uterine horn bag 12 are respectively provided with a first pressing point 41, and each first pressing point 41 is provided with a pressure sensor; two second pressing points 42 are symmetrically arranged at the lower part of the body cavity sac 11, and a pressure sensor is arranged at each second pressing point 42. After the body cavity bag 11 is unfolded, the body cavity bag 11 is tightly attached to the wall of the uterus 3, the attaching part is mainly positioned at the lower section of the uterus 3, and the joint of the body cavity bag 11 and the wall of the uterus 3 mainly corresponds to the lower part of the body cavity bag 11, so that the left side and the right side of the joint are respectively provided with 1 pressure sensor, and the pressure in the uterine cavity (the contraction force of the uterus 3) can be monitored in real time. The left side and the right side of the junction of the uterine horn sac 12 and the wall of the uterus 3 are respectively provided with 2 pressure sensors which can monitor the pressure (the contraction force of the uterus 3) at the uterine horn 31 in real time. The pressure sensor is communicated with a controller through communication signals, the controller is electrically connected with an external display, the pressure sensor transmits pressure signals to the controller, the pressure signals are transmitted to the display through the controller in a conversion mode, and the pressure signals are displayed on a screen of the display.
preferably, the included angle between the vertical lines of the tangents of the two first compression points 41 at the uterine horn pouch 12 at the intersection point is β, the β angle ranges from 70 ° to 100 °, the postpartum uterine angle is 90 ° theoretically, the β angle is also 90 °, if postpartum uterine contraction is not good, or contraction is poor due to placenta attachment, the uterine angle can be enlarged, and the β angle is reduced, so the α angle range is set from 70 ° to 100 °.
Preferably, the included angle between the vertical lines of the tangents of the two second compression points 42 at the body cavity capsule 11 at the intersection point is γ, the γ angle ranges from 90 ° to 150 °, the magnitude of the γ angle is affected by the force of the contraction of the lower uterine segment, if the contraction of the lower uterine segment is good, the γ angle becomes smaller, otherwise, the γ angle becomes larger, so the γ angle range is set to 90 ° to 150 °
Preferably, the pressure sensor is a flexible film pressure sensor, in the embodiment, the flexible ultrathin pressure sensor is a flexible ultrathin pressure sensor of SI4-G brand in Hanwei brand, and the flexible ultrathin pressure sensor is composed of an ultrathin film, a conductive material and a nanometer pressure sensitive layer, has high sensitivity, is only 0.1mm thick, is good in flexibility, can be freely bent, is excellent in mechanical property, and can meet the use requirement.
According to the uterus tamponade hemostatic balloon, a use method of the uterus tamponade hemostatic balloon comprises the following steps:
step A, after the vaginal delivery placenta is delivered, pressing the bottom of the uterus 3, knowing the height of the bottom of the uterus and the contraction condition of the uterus 3, checking and repairing the soft birth canal, checking the bleeding condition, and judging the bleeding part of the uterus 3;
b, the uterus is filled with a hemostatic balloon and sent into the uterine cavity through the cervical orifice;
step C, connecting the drainage bag 231 to the lower end of the drainage tube 23, and regularly recording the uterine cavity bleeding amount;
step D, injecting physiological saline into different capsule bodies according to the bleeding part of the uterus 3;
and E, monitoring the bleeding condition of the uterus 3 at any time after the balloon is placed, and taking out the balloon after bleeding stops.
Preferably, in the step B, when the hemostatic balloon for filling the uterus is delivered into the uterine cavity through the cervical orifice, the balloon placement position needs to be ensured to be accurate, and the specific method comprises the following steps: slowly sending the saccule into the uterine cavity from the cervical orifice, and stopping pushing inwards when pushing resistance is sensed, namely the end part of the drainage tube 23 is just abutted against the top of the uterus 3; because the length of the part of the upper end of the drainage tube 23, which extends out of the body cavity bag 11, is 5-8mm, the length of the exposed section is designed according to the structure of the uterus 3, so that when the end part of the drainage tube 23 is just abutted against the top of the uterus 3, the body cavity bag 11 is just pressed on the lower section of the uterus 3, and meanwhile, the two uterine horn bags 12 are just positioned at the uterine horns 31. Because the balloon is mainly placed by the touch operation of doctors, when the end part of the drainage tube 23 is just abutted against the top of the uterus 3, the balloon can be used as a signal for accurate placement of the balloon, a reference basis is provided for the operation of the doctors, and the accuracy of the placement position of the balloon can be preliminarily ensured.
Meanwhile, the position of the balloon is checked to be accurate by matching with B-ultrasonic monitoring, and the position of the balloon is properly adjusted according to the result of the B-ultrasonic monitoring, so that the body cavity bag 11 and the two uterine horn bags 12 are ensured to be arranged at the accurate positions in the uterus 3.
Preferably, in step D, the method for injecting saline into the different capsules comprises:
firstly, when a bleeding part is positioned at the lower section of a uterus 3, injecting physiological saline into a body cavity sac 11 through a main sac catheter 21 by an injector, wherein the maximum injection amount is 800ml, firstly injecting 350-400 ml, monitoring the numerical value of a pressure sensor at a second compression point 42, namely the contraction force of the uterus 3, stopping injecting water when the contraction force of the uterus 3 reaches or approaches 150mmHg, and closing a control valve 25;
secondly, when the bleeding part is positioned at the uterine horn 31, firstly injecting normal saline into the body cavity sac 11 according to the method in the first method, then injecting the normal saline into the uterine horn 12 through the lateral sac catheter 22 by using an injector, wherein the maximum injection amount is 200ml, firstly injecting 50-100 ml, monitoring the numerical value of a pressure sensor at 4 first compression points 41, namely the contraction force of the uterine horn 31, and when the contraction force of the uterine 3 reaches or approaches 150mmHg, injecting 10-20 ml as appropriate, stopping water injection, and closing the control valve 25; after the uterine horn bag 12 is gradually unfolded, a small amount of physiological saline is injected, so that the uterine horn bag 12 is further attached to the wall of the uterus 3 at the uterine horn 31, the uterine horn bag 12 is closely attached to the inner wall of the uterine horn 31, and the compression effect is effectively achieved.
And thirdly, when bleeding prevention is needed after delivery, the operation method in the second method is adopted as a measure for preventing the bleeding after delivery.
Therefore, the balloon can be used for flexibly selecting water injection into different balloons according to the actual bleeding position, adopting a targeted compression mode, or being applied to postpartum hemorrhage preventive use, so that the application range is wide, the treatment of bleeding at different parts is more targeted, and the hemostatic effect is better.
Preferably, in the step E, the bleeding condition of the uterus 3 is monitored in real time by using a numerical value fed back by a pressure sensor installed on the surface of the balloon, the data is analyzed according to the numerical value of the sub-pressure at each point recorded in a display, namely the contraction force of the uterus 3 and the contraction force values of the uterine horns 31 at two sides, the contraction force values of the uterine horns 31 at two sides are compared, the contraction condition of the uterus 3 is monitored and analyzed by data monitoring, the dropping speed and the dosage of the oxytocin are adjusted in time, the organism is waited to exert the blood coagulation function of the organism to form thrombus, and the next diagnosis and; if the postpartum uterine contractility value is close to or reaches 350mmHg, if the vaginal bleeding is not much at the moment, the uterine contractility is good, and the oxytocin dropping speed can be adjusted to the conventional dosage; if the postpartum uterine contraction force value is far less than 350mmHg, the dripping speed or dosage of oxytocin is increased while the vaginal blood flow is observed. At the moment, according to the numerical condition of the compression point, the uterine contractility condition can be objectively and accurately evaluated, the times of vaginal examination are reduced, the risk of infection is reduced, the delivery experience is improved, and the perinatal period ending is improved.
According to the numerical value of the sub-pressure at each point recorded in the display, when the contraction force of the postpartum uterus 3 reaches 350-400mmHg, the contraction force of the uterus 3 is prompted to be good, and the balloon can be withdrawn in combination with the actual postpartum hemorrhage amount.
Therefore, in the process, the pressure sensors are used for monitoring the contraction force of the uterus 3 and the contraction forces of the uterine horns 31 on the two sides in a combined manner, so that the bleeding condition can be monitored in real time, the balloon is taken out after 24 hours, the bleeding condition can be timely mastered if the balloon can be monitored in real time, the balloon does not need to wait for 24 hours, and the balloon can be withdrawn as required after bleeding stops. Shortening the treatment time and reducing the patient's pain (if there is no recorded compression point value, it is necessary to frequently check uterine contractions, or to press the fundus from the abdominal wall, but with poor accuracy, or to massage the uterus from the vaginal examination, the parturient is very uncomfortable and increases the chance of infection).
Moreover, the pressure sensor is used for real-time monitoring, so that the bleeding condition can be analyzed in time, the treatment scheme can be adjusted in time, the delay of the illness state can be prevented, the patient can be treated effectively in a targeted manner, the diagnosis and treatment in the next step can be guided, and the treatment effect can be improved.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (10)
1. A uterine tamponade hemostatic balloon, characterized in that: the uterine cavity angle balloon comprises a balloon and a catheter group (2), wherein the balloon comprises a body cavity balloon (11) and two uterine angle balloons (12), the uterine angle balloons (12) are fixedly connected to the outer surface of the balloon, the interiors of the uterine angle balloons (12) and the body cavity balloon (11) are not communicated, and the two uterine angle balloons (12) are respectively positioned at the upper left corner and the upper right corner of the body cavity balloon (11);
the catheter group (2) comprises a main balloon catheter (21), side balloon catheters (22) and a drainage tube (23), the main balloon catheter (21) communicates the body cavity balloon (11) with the liquid injection port of an external injector, the side balloon catheters (22) communicate the two uterine horn balloons (12) with the liquid injection port of the external injector respectively, the drainage tube (23) penetrates through the body cavity balloon (11), the upper end of the drainage tube (23) extends out of the body cavity balloon (11), and the lower end of the drainage tube (23) is connected with a drainage bag (231).
2. the uterine tamponade hemostatic balloon according to claim 1, wherein the angle between the central axes of the two uterine angle balloons (12) at the intersection point is α, and the α angle ranges from 90 ° to 120 °.
3. The uterine tamponade hemostatic balloon of claim 1, wherein: the length of the part of the upper end of the drainage tube (23) extending out of the body cavity sac (11) is 8-10 mm.
4. The uterine tamponade hemostatic balloon of claim 1, wherein: the catheter group (2) also comprises an outer sleeve (24), the main balloon catheter (21), the side balloon catheter (22) and the drainage tube (23) are tightly wrapped through the outer sleeve (24) to form an integral tube bundle structure, and the outer wall of the outer sleeve (24) is fixedly connected with the body cavity balloon (11) in a sealing way at the position where the catheter group (2) penetrates into the body cavity balloon (11);
the upper end of the main bag conduit (21) is positioned in the body cavity bag (11), the lower end of the main bag conduit (21) penetrates out of the body cavity bag (11) through the outer sleeve (24) and is provided with a control valve (25) near the outlet, the upper end of the side bag conduit (22) is branched into a branch pipe I (221) and a branch pipe II (222), the upper ends of the branch pipe I (221) and the branch pipe II (222) penetrate through the cavity wall of the body cavity bag (11) and extend into the uterine horn bag (12) to be communicated with the uterine horn bag (12), the lower end of the side bag conduit (22) penetrates out of the body cavity bag (11) through the outer sleeve (24) and is provided with a control valve (25) near the outlet; the drainage tube (23) is provided with a control valve (25) near the interface with the drainage bag (231).
5. The uterine tamponade hemostatic balloon of claim 1, wherein: the lower part of the body cavity sac (11) is provided with a concave part (111), and the surface of the concave part (111) is provided with an anti-skid bulge (112); the top of the uterine horn bag (12) is provided with a bulge part (121).
6. the uterine tamponading hemostatic balloon according to claim 5, further comprising a plurality of pressure sensors attached to different positions on the balloon surface, wherein the two sides of the convex portion (121) of the uterine horn sac (12) are respectively provided with a first pressure point (41), each first pressure point (41) is provided with one pressure sensor, the lower portion of the uterine horn sac (11) is symmetrically provided with two second pressure points (42), each second pressure point (42) is provided with one pressure sensor, the pressure sensors are communicated with a controller through communication signals, the controller is electrically connected with an external display, the included angle of the vertical lines of the tangent lines of the two first pressure points (41) at the uterine horn sac 12 at the intersection point is β, the included angle of the β ranges from 70 degrees to 100 degrees, the included angle of the vertical lines of the tangent lines of the two second pressure points (42) at the uterine horn sac 11 at the intersection point is gamma, and the included angle of the gamma ranges from 90 degrees to 150 degrees.
7. A method of using the uterine tamponade hemostatic balloon of any one of claims 1-6, wherein: the method comprises the following steps:
step A, after the placenta is delivered during vaginal delivery, pressing the bottom of the uterus (3), knowing the height of the bottom of the uterus and the contraction condition of the uterus (3), checking and repairing the soft birth canal, checking the bleeding condition, and judging the bleeding part of the uterus (3);
b, the uterus is filled with a hemostatic balloon and sent into the uterine cavity through the cervical orifice;
step C, connecting the drainage bag (231) to the lower end of the drainage tube (23), and recording the uterine bleeding amount at regular time;
step D, injecting physiological saline into different capsule bodies according to the bleeding part of the uterus (3);
and E, monitoring the bleeding condition of the uterus (3) at any time after the balloon is placed, and taking out the balloon after bleeding stops.
8. The method of using a uterine tamponade hemostatic balloon of claim 7, wherein: in the step B, when the hemostatic saccule for filling the uterus is sent into the uterine cavity through the cervical orifice, the accurate placement position of the saccule needs to be ensured, and the specific method comprises the following steps: the saccule is slowly sent into the uterine cavity from the cervical orifice, and when pushing resistance is sensed, namely the end part of the drainage tube (23) is just abutted against the top of the uterus (3), inward pushing is stopped; meanwhile, the position of the balloon is checked to be accurate by matching with B-ultrasonic monitoring, and the position of the balloon is properly adjusted according to the result of the B-ultrasonic monitoring.
9. The method of using a uterine tamponade hemostatic balloon of claim 7, wherein: in step D, the method for injecting saline into different capsules comprises:
firstly, when a bleeding part is positioned at the lower section of a uterus (3), injecting physiological saline into a body cavity sac (11) through a main sac catheter (21) by an injector, wherein the maximum injection amount is 800ml, firstly injecting 350-400 ml, monitoring the numerical value of a pressure sensor at a second compression point (42), namely the contraction force of the uterus (3), stopping injecting water when the contraction force of the uterus (3) reaches or approaches 150mmHg, and closing a control valve (25);
secondly, when the bleeding part is positioned at the uterine horn (31), firstly injecting normal saline into the body cavity sac (11) according to the method in the first method, then injecting the normal saline into the uterine horn sac (12) through the side sac catheter (22) by an injector, wherein the maximum injection amount is 200ml, firstly injecting 50-100 ml, monitoring the pressure sensor value at 4 first compression points (41), namely the contraction force of the uterine horn (31), when the contraction force of the uterus (3) reaches or approaches 150mmHg, injecting 10-20 ml as appropriate, stopping injecting water, and closing the control valve (25);
and thirdly, when bleeding prevention is needed after delivery, the operation method in the second method is adopted as a measure for preventing the bleeding after delivery.
10. The method of using a uterine tamponade hemostatic balloon of claim 7, wherein: step E, monitoring the bleeding condition of the uterus (3) in real time by using a numerical value fed back by a pressure sensor arranged on the surface of the balloon, analyzing data according to the numerical value of the child pressure at each point recorded in a display, namely the contraction force of the uterus (3) and the contraction force values of the uterine horns (31) at two sides, comparing the contraction force values of the uterine horns (31) at two sides, monitoring and analyzing the contraction condition of the uterus (3) by using the data, adjusting the dropping speed and the dosage of oxytocin in time, waiting for an organism to exert the blood coagulation function of the organism to form thrombus, and guiding the next diagnosis and treatment; if the postpartum uterine contractility value is close to or reaches 350mmHg, if the vaginal bleeding is not much at the moment, the uterine contractility is good, and the oxytocin dropping speed can be adjusted to the conventional dosage; if the postpartum uterine contraction force value is far less than 350mmHg, the dripping speed or dosage of oxytocin is increased while the vaginal blood flow is required to be observed;
according to the numerical value of the sub-pressure at each point recorded in the display, when the contraction force of the uterus (3) after delivery reaches 350-400mmHg, the contraction force of the uterus (3) is indicated to be good, and the balloon can be withdrawn in combination with the actual amount of the bleeding after delivery.
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| CN112168267A (en) * | 2020-10-20 | 2021-01-05 | 天津市第三中心医院 | Hemostasis bulb subassembly and postpartum hemostasis equipment |
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