CN118902531B - High-precision hemostatic balloon and system - Google Patents
High-precision hemostatic balloon and system Download PDFInfo
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- CN118902531B CN118902531B CN202411321159.3A CN202411321159A CN118902531B CN 118902531 B CN118902531 B CN 118902531B CN 202411321159 A CN202411321159 A CN 202411321159A CN 118902531 B CN118902531 B CN 118902531B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/42—Gynaecological or obstetrical instruments or methods
- A61B17/4241—Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10181—Means for forcing inflation fluid into the balloon
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B2017/12004—Surgical 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)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Reproductive Health (AREA)
- Child & Adolescent Psychology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Surgical Instruments (AREA)
Abstract
本发明公开了高精度止血球囊及系统，涉及医疗器械技术领域。高精度止血球囊用于子宫腔止血，包括球囊组件和导管组件，球囊组件包括宫腔内止血球囊和阴道内固定球囊；宫腔内止血球囊包括主要用于压迫子宫前后壁的中间球囊和主要用于压迫子宫的左右侧壁的左、右侧球囊，三球囊形成一个上宽下窄、前后径小于左右径的扁平状倒置梨形；阴道内固定球囊在膨胀后卡固在阴道穹窿内并包绕宫颈，对宫腔止血球囊进行托举的同时闭合宫颈内口；导管组件用于对积血进行引流，以及对球囊组件进行流体充注和放流。本发明利用宫颈口处阴道穹窿的特点，设置了阴道内固定球囊托举止血球囊并闭合宫颈内口，同时采用多腔止血球囊提高了球囊的区域压迫精度。
The invention discloses a high-precision hemostatic balloon and system, and relates to the field of medical device technology. The high-precision hemostatic balloon is used for uterine cavity hemostasis, including a balloon assembly and a catheter assembly, the balloon assembly including an intrauterine cavity hemostatic balloon and an intravaginal fixed balloon; the intrauterine cavity hemostatic balloon includes a middle balloon mainly used to compress the front and back walls of the uterus and left and right balloons mainly used to compress the left and right side walls of the uterus, and the three balloons form a flat inverted pear shape with a wide top and a narrow bottom, and a front and back diameter smaller than the left and right diameters; the intravaginal fixed balloon is fixed in the vaginal vault after expansion and surrounds the cervix, while lifting the intrauterine cavity hemostatic balloon and closing the internal cervical os; the catheter assembly is used to drain the accumulated blood, and to fill and discharge the balloon assembly with fluid. The present invention utilizes the characteristics of the vaginal vault at the cervical os, and sets an intravaginal fixed balloon to lift the hemostatic balloon and close the internal cervical os, while using a multi-cavity hemostatic balloon to improve the regional compression accuracy of the balloon.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a high-precision hemostatic bag and a high-precision hemostatic bag system for uterine cavity hemostasis.
Background
Gynecological and obstetrical patients may develop significant bleeding, for example, from trauma, abortion, vaginal or caesarean delivery, or from various other causes such as premature placenta peeling, premature placenta, placenta implantation or penetration of the placenta or implanted placenta, clotting disorders, etc. Currently, therapeutic methods for treating gynecological/obstetrical hemorrhages may include blood products and/or drug interventions (such as coagulation mediators, uterine contractile drugs), uterine massage and compression suturing, surgery, and interventional radiology. The gauze is filled in the uterus to stop bleeding, but the gauze is difficult to manufacture and fill, the pressure on the inner wall of the uterine cavity is uneven, dead cavities are easy to form, the hemostasis is failed, the surface of the gauze is rough, the smoothness is poor, once the yarn threads fall off, the intrauterine environment is polluted, and the pain of a patient is increased.
IN response to the above problems, balloon catheters (ballooncatheter) originally developed for other purposes, such as Foley balloon catheters, rusch balloon catheters, were applied to uterine cavity hemostasis, and balloon catheters developed specifically for the treatment of post uterine bleeding, such as SOS Bakri balloon-filled catheters (manufactured by Cook Medical inc., bloom gton, IN) were developed later. Bakri A filling balloon catheter is a balloon catheter specially developed for treating postpartum hemorrhage without damaging uterus, the structure of the hemostatic balloon is similar to that of arranging a balloon at the top of a catheter, the balloon can be fixed in uterus after being filled with liquid (or other fluids) after being inflated, and can prop against the internal cervical orifice, so that the blood flows in from an opening at the upper end of the balloon and flows out from an outlet of a guide tube, and then the accumulated blood in the uterine cavity is drained. On the one hand, by placing the hemostatic balloon in the uterine cavity of the bleeding puerpera, the hemostatic balloon generates a hydrostatic pressure from the uterine cavity to the outside of the uterine cavity, the hydrostatic pressure is larger than uterine arterial pressure, and the balloon after water injection is directly pressed on the inner wall of the middle lower end of the uterus, namely the uterine artery inlet, so that postpartum uterine bleeding can be effectively reduced. On the other hand, the saccule can also press the blood sinus which is opened at the attachment part of the placenta on the endometrium surface, thereby further reducing the uterine bleeding.
However, the conventional uterine cavity hemostatic sac body is generally in a long cylinder shape or a round sphere shape, which is not in accordance with the actual shape of uterus, as shown in fig. 1, the normal uterine form is generally in an inverted pear shape with slightly flattened front and back, the uterine cavity is in a triangle shape with wide upper part and narrow lower part, the capacity of the uterine cavity is increased to 5000ml during pregnancy, the fetal placenta is delivered out, the uterine cavity form is still in a wide upper part and narrow lower part, and the uterine form is still in a transverse diameter larger than the front and back diameter, so that the hemostatic sac cannot be well attached to the uterine bottom and the uterine corners at two sides in the uterine cavity. Meanwhile, the balloon is often positioned at the middle and lower section of the uterine cavity when placed, even positioned in the lower section and the cervical canal, and is easy to slip because the cervical part cannot be fixed, especially for patients with bleeding after the caesarean section after the downstream and the large opening of the uterine opening, and is easier to slip because of the relaxation of the uterine opening and/or the laceration of the uterine neck. Accordingly, in recent years, a hemostatic balloon adapted to the size and shape of the uterine cavity has also appeared, and a cervical cover has been added to prevent the hemostatic balloon from slipping down in the uterus. For example, patent ZL202020503679.7 discloses a uterine cavity hemostasis assembly, which comprises a hemostatic bag, a liquid injection pipe, a uterine cavity drainage tube and a liquid injection device, wherein the upper end of the hemostatic bag is inwards sunken to form a drainage port, a cervical cover is arranged below the hemostatic bag, a spiral line is arranged on the side wall of the drainage port, the drainage port is connected with the uterine cavity drainage tube, the uterine cavity drainage tube penetrates through the hemostatic bag and extends out from the lower end, an air bag is arranged in the cervical cover, a sliding channel is arranged in the middle of the cervical cover, the uterine cavity drainage tube can slide in the sliding channel, the periphery of the inflated cervical cover is raised, the middle is sunken and can be clamped between the inner sides of a vaginal fornix and a pubic bone arch, and the cervical cover is extruded towards the inner sides of the cervical port, so that the cervical port tends to be closed. the proposal provides the hemostatic balloon with a wide upper part and a narrow lower part, and simultaneously, the hemostatic balloon is also provided with the cervical opening part which can be extruded, so that the prolapsed cervical orifice is closed upwards, and the cervical cover balloon which can prevent the hemostatic balloon from being extruded from the cervical orifice is avoided. For another example, chinese patent ZL202121718055.8 discloses a novel uterine and cervical hemostatic balloon, which comprises a hemostatic balloon, a drainage tube fixedly arranged on the hemostatic balloon, an annular cervical cover fixedly sleeved on the drainage tube, a main collecting ball fixedly arranged at the bottom end of the drainage tube, a liquid-through guide hole formed in the drainage tube, a liquid injector fixedly arranged on the outer wall of one side of the drainage tube, one end of the liquid injector fixedly connected with the bottom of the liquid-through guide hole in a sealing manner, and an air blower fixedly arranged at the bottom of the cervical cover. When the hemostatic sac is used, the collapsed hemostatic sac is plugged into the uterus of a puerpera by holding the drainage tube, when the cambered surface contact cover is slightly blocked and is in contact with the inner wall of the uterus, the plugging can be stopped, meanwhile, the upper end and the lower end of the cervical cover are well pushed into a fornix and a pubic arch positioned behind the vagina, the cervical cover is enabled to stably prop against the vaginal part of the cervix through the air blowing device to blow air into Gong Gengzhao, when the puerpera bleeds or bleeds, physiological saline is injected into the liquid guide hole through the liquid injector, the physiological saline can be extruded into the liquid guide hole to flow out from the top outlet of the liquid guide hole, the hemostatic sac is propped up, the inner wall of the uterus is compressed after being propped up, the blood vessel of the wound surface of the uterine cavity is compressed, the uterine contraction is induced, so that the hemostatic aim is achieved, and meanwhile, the overflowed blood is extruded into the two fan-shaped drainage holes and drained through the drainage tube. The cervical cover in the scheme can avoid the blood stopping bag from falling out of the cervical orifice after being inflated.
However, the above-described existing uterine cavity hemostatic bags have the following disadvantages:
1) The traditional uterine cavity hemostatic balloon generally adopts a single-cavity balloon, which can well compress the front wall and the rear wall of the uterus, but the compression to the uterine side wall is often insufficient, and the uterine artery ascending branch walks along the uterine side wall, so that the hemostatic effect of the hemostatic balloon is poor due to the insufficient compression. In practical application, it is found that even if the single-cavity hemostatic balloon is set to be in a shape with a wide upper part and a narrow lower part so as to adapt to the shape of the uterine cavity, the expansion area and the inflation degree of the area can not be controlled when the single-cavity balloon is inflated, and the requirement for better compression on the uterine side wall area, the placenta attachment area or the active bleeding area is still difficult to meet when the single-cavity balloon is inflated. How to set the regional expansion performance and the regional inflation degree of the uterine cavity hemostatic bag based on the shape of the uterine cavity so as to improve the regional compression precision of the hemostatic bag is a technical problem which needs to be solved currently. Further, it is often clinically desirable to adjust the regional pressure of the hemostatic bladder according to the condition of the tissue/bleeding in the cavity of the patient to control the force of the bladder against a certain or certain regions of the uterine cavity wall, such as the desire to increase/decrease the force of compression against a certain region of the back of the cavity wall without increasing/decreasing the force of compression against other regions, and it is difficult for existing hemostatic bladders to meet the need for fine adjustment of regional pressure.
2) When the hemostatic balloon is clinically used for treating postpartum hemorrhage, the condition that the uterine cavity hemostatic balloon cannot be well sent to the uterine bottom or the upper segment of the uterine cavity often occurs. In the operation process, if the uterine cavity is adhered, the uterine cavity is abnormal (the uterus is excessively inclined forwards or backwards), the uterine cavity of the uterine body is narrow, the saccule is not easy to be placed at the bottom of the uterus, and the saccule is extremely easy to be folded and slipped out. At present, in order to put into the hemostatic bag, oval forceps are often used, but the oval forceps are limited in length and thick, so that when the uterus cavity is accessed, the uterus and the cervical canal are easily damaged, and great pain is brought to a patient.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provides a high-precision hemostatic bag and a high-precision hemostatic system. The invention provides a high-precision hemostatic balloon, which comprises a balloon component and a catheter component, wherein the balloon component is arranged on the catheter component and comprises an intrauterine hemostatic balloon and an intravaginal fixed balloon, on one hand, the intrauterine hemostatic balloon adopts a multi-cavity balloon to form a flat inverted pear shape with a wide upper part, a narrow lower part and a smaller front-back part than a left-right part, the middle balloon is mainly used for pressing the front-back wall of the uterus, the left-right side balloon is mainly used for pressing the left-right side wall of the uterus, the regional pressing precision of the hemostatic balloon is improved by adopting the multi-cavity balloon, and meanwhile, the characteristics of the vaginal vault at the cervical orifice are utilized, the intravaginal fixed balloon which can be clamped in the vaginal vault at the top end of the vagina and wrapped around the cervix is arranged, and the intrauterine orifice is closed while the intrauterine hemostatic balloon is lifted. Further, the invention thickens the balloon wall between the middle balloon and the balloons on two sides to limit the expansibility of the balloon at a thicker wall, so that the expansion of the balloon is guided to a thinner area of the balloon wall on the outer side, and the expansion of the hemostatic balloon can be promoted to be more towards the outer side when the hemostatic balloon is filled, thereby better realizing the effect that the middle balloon is mainly used for pressing the front and rear walls of the uterus and the left and right side balloons are mainly used for pressing the side wall of the uterus.
In order to achieve the above object, the present invention provides the following technical solutions:
a high precision hemostatic balloon for uterine cavity hemostasis, comprising:
The intrauterine hemostatic balloon comprises a middle balloon, a left balloon and a right balloon, wherein the middle balloon, the left balloon and the right balloon form a flat inverted pear shape with wide upper part and narrow lower part, and the front diameter and the rear diameter are smaller than the left diameter and the right diameter after being combined, the cavities of the middle balloon, the left balloon and the right balloon are mutually independent, the middle balloon is mainly used for pressing the front wall and the rear wall of the uterus after being inflated, the left balloon and the right balloon are mainly used for pressing the left side wall and the right side wall of the uterus after being inflated, and the intravaginal hemostatic balloon is used for being clamped in a vaginal vault at the top end of the vagina and surrounding the cervix after being inflated, and closing an intrauterine opening while lifting the intrauterine hemostatic balloon;
the catheter assembly is used for draining the accumulated blood in the uterine cavity and performing fluid filling and discharging on the balloon assembly.
Further, the internal vaginal fixation saccule is an annular saccule, the inner ring of the annular saccule is matched with the cervical peripheral size at the position of the vaginal fornix, and the annular saccule body is matched with the vaginal fornix in size;
the fluid filled in the uterine cavity during the expansion of the hemostatic saccule and the vaginal fixed saccule is liquid.
Further, the catheter assembly includes:
The distal end of the flexible drainage tube sequentially passes through the inner ring of the intravaginal fixed saccule and the inner cavity of the intrauterine hemostat and then extends out of the intrauterine hemostat, the distal end of the drainage tube is provided with a drainage port for draining the hematocrit in the uterine cavity, and the proximal end of the drainage tube is connected with a drainage device;
The intrauterine hemostatic balloon catheter is used for communicating the middle balloon, the left balloon and the right balloon with an external filling device, wherein independent middle balloon catheter, left balloon catheter and right balloon catheter are respectively arranged for the middle balloon, the left balloon catheter and the right balloon catheter, the distal ends of the balloon catheters are communicated with the inner cavities of the corresponding balloons, the proximal ends of the balloon catheters are provided with valves for opening or closing the catheter ports, and the catheter ports are connected with the filling device;
The vaginal fixed saccule pipeline is used for communicating the vaginal fixed saccule with an external filling device, the distal end of the vaginal fixed saccule pipeline is communicated with the inner cavity of the vaginal fixed saccule, and the proximal end of the vaginal fixed saccule pipeline is provided with a valve for opening or closing a pipeline opening which is connected with the filling device.
Further, the balloon wall of the middle balloon comprises a side balloon connecting area and a non-connecting area, and the balloon wall thickness of the side balloon connecting area is larger than that of the non-connecting area, so that the middle balloon is inflated more towards the direction of the front and rear walls of the uterus when inflated and expanded to realize that the middle balloon is mainly used for pressing the front and rear walls of the uterus;
The balloon wall of the left balloon and the balloon wall of the right balloon comprise a middle balloon connecting area and a non-connecting area, and the balloon wall thickness of the middle balloon connecting area is larger than the balloon wall thickness of the non-connecting area, so that the left balloon and the right balloon are respectively inflated to the left side and the right side of the uterus when inflated and expanded to be mainly used for pressing the side wall of the uterus, wherein the inflated left balloon and the inflated right balloon can effectively press the left side wall and the right side wall of the lower section of the uterus to block the ascending branch of uterine arteries.
The middle balloon adopts a multi-cavity structure, comprises a central cavity and balloon cavity units which are radially distributed around the central cavity, wherein cavities among the balloon cavity units are mutually independent, each balloon cavity unit is communicated with the central cavity through a balloon cavity channel, and a traction wire for pressure regulation is arranged in each balloon cavity unit;
the catheter assembly further comprises an operation cavity for the middle balloon operation bracket to enter the central cavity, and the middle balloon operation bracket adopts a pipe structure;
Each balloon cavity unit is provided with a distal end and a proximal end, the first end of the traction wire is connected to the balloon wall at the distal end of the balloon cavity unit, the second end of the traction wire penetrates through the balloon cavity channel at the proximal end of the balloon cavity unit, is led into the lumen of the middle balloon operation support through the central cavity and is led out from the lumen outlet of the middle balloon operation support, and the second end of the traction wire is pulled by a user or pulled by the traction adjusting device to adjust the distal balloon wall of each balloon cavity unit, so that the regional pressure of the uterine cavity region corresponding to the balloon cavity unit is adjusted.
Further, each capsule cavity unit is provided with a traction wire, the traction wire and the capsule wall at the far end of the capsule cavity unit carry out punctiform traction, at the moment, the capsule wall at the far end of the capsule cavity unit is provided with a thickening area, the first end of the traction wire is connected with the thickening area, and the second end of the traction wire is pulled during traction so as to enable the first end of the traction wire to move towards the central cavity;
Or a plurality of traction wires are arranged in each capsule cavity unit, planar traction is realized through the plurality of traction wires and the capsule wall at the far end of the capsule cavity unit, the first ends of the plurality of traction wires are respectively connected to different orientations of the capsule wall at the far end of the capsule cavity unit, and the second ends of the plurality of traction wires are pulled simultaneously during traction so that the first ends of the plurality of traction wires move towards the direction of the central cavity simultaneously.
Further, each of the balloon units is also provided with a balloon stent capable of being filled with fluid, and the balloon stent forms a reinforced support between the proximal end and the distal end of the balloon unit after being filled with fluid;
The balloon cavity support is sequentially connected by a plurality of independent cavity sections, comprises a head cavity section, a tail cavity section and at least one middle cavity section, wherein the head cavity section is connected with the far-end balloon wall of the balloon cavity unit, the tail cavity section is connected with the near-end balloon wall of the balloon cavity unit, the middle cavity section is positioned between the head cavity section and the tail cavity section and is connected in a nested mode, independent guide pipes are respectively arranged corresponding to the head cavity section, the tail cavity section and the middle cavity section, when filling is needed, fluid is respectively filled into the head cavity section, the tail cavity section and the middle cavity section through the respective guide pipes, and when compression force of the balloon cavity unit corresponding to a uterine cavity area needs to be reduced, part of the fluid in the head cavity section is released.
The invention also discloses a hemostatic balloon system, which comprises:
A blood stopping capsule, which is the high-precision blood stopping capsule according to any one of claims 1 to 7;
The balloon boosting device is detachably connected with the flexible drainage tube and is used for being attached to or inserted into the drainage tube to support the catheter assembly when the balloon is placed, so that the intrauterine hemostatic balloon of the hemostatic balloon is guided to be placed at the bottom of a womb or the upper section of the womb.
The cervical ring binding belt is used for horizontally cerclaging the cervix to close the internal cervical orifice, is connected to the catheter component and is arranged corresponding to the position of the internal vaginal fixation balloon;
The cervical ring binding belt comprises a ring binding ring and a telescopic buckle, and the telescopic buckle can adjust the tightness of the ring binding ring.
Further, the balloon boosting device is a guide tube, a guide tube sub-cavity is arranged on the drainage tube for the insertion of the guide tube, the hardness of the guide tube is larger than that of the drainage tube for improving the bending resistance and toughness of balloon placement, and after the balloon is placed in place, the guide tube can be separated from the drainage tube to take out the guide tube;
the guide tube is provided with scales for indicating the position of the balloon delivered to the uterine cavity.
Compared with the prior art, the high-precision hemostatic balloon provided by the invention has the advantages and positive effects that the high-precision hemostatic balloon comprises the balloon component and the catheter component, the balloon component is arranged on the catheter component and comprises the intrauterine hemostatic balloon and the intravaginal fixing balloon, on one hand, the intrauterine hemostatic balloon adopts the multichamber balloon to form a flat inverted pear shape with the upper width and the lower width and the front and back diameters smaller than the left and right diameters, the middle balloon is mainly used for pressing the front and back walls of the uterus, the left and right side balloons are mainly used for pressing the left and right side walls of the uterus, the regional pressing precision of the hemostatic balloon is improved by adopting the multichamber balloon, and meanwhile, the intrauterine fixed balloon which can be clamped in the vaginal vault at the top end of the vagina and wrapped around the cervix is arranged by utilizing the characteristics of the vaginal vault at the cervical opening, and the intrauterine opening is closed while the intrauterine hemostatic balloon is lifted. Further, the invention thickens the balloon wall between the middle balloon and the balloons on two sides to limit the expansibility of the balloon at a thicker wall, so that the expansion of the balloon is guided to a thinner area of the balloon wall on the outer side, and the expansion of the hemostatic balloon can be promoted to be more towards the outer side when the hemostatic balloon is filled, thereby better realizing the effect that the middle balloon is mainly used for pressing the front and rear walls of the uterus and the left and right side balloons are mainly used for pressing the side wall of the uterus.
On the other hand, the hemostatic balloon capable of adjusting the regional pressure is also provided, the compression force of the balloon to a certain or certain regions of the uterine cavity wall after the balloon is inflated can be controlled according to the requirement, and the precise adjustment of the regional pressure of the balloon is realized.
The invention also provides a system comprising the high-precision hemostatic bag, which comprises a guide tube as a balloon boosting device, wherein the balloon catheter can be provided with a guide tube sub-cavity at the moment, so that the guide tube can be attached to or inserted into a drainage tube to improve the bending resistance and toughness of the balloon catheter when the balloon catheter is placed into a uterine cavity. After the balloon is placed in place, the guide tube can be separated from the balloon catheter to maintain the flexibility of the balloon catheter, so that the efficiency of placing the hemostatic balloon into the uterine cavity is provided, and the pain of a patient is reduced.
In another aspect, a cervical ring tie may be included that may be attached to a catheter assembly (preferably a drainage tube) of a hemostatic balloon for horizontally cerclage to close an endocervical opening. Under the double-layer effect of the ring binding belt and the internal vaginal fixation saccule, the blood stopping saccule can be better prevented from slipping, and the cervical can be kept or the normal anatomical structure is restored to help to stop bleeding, and meanwhile, the blood accumulating in the uterine cavity is not influenced.
Drawings
Fig. 1 is a schematic structural view of a uterine cavity.
Fig. 2 is a schematic structural diagram of a high-precision hemostatic bag according to an embodiment of the present invention.
Fig. 3 is a schematic diagram of an arrangement of intrauterine hemostat ducts according to an embodiment of the present invention.
Fig. 4 is a schematic structural view of an annular intravaginal fixation balloon according to an embodiment of the present invention.
Fig. 5 is a schematic structural view of a catheter assembly according to an embodiment of the present invention.
Fig. 6 is a schematic structural diagram of a side balloon connection region and a non-connection region of a middle balloon according to an embodiment of the present invention.
Fig. 7 is a schematic diagram of an intermediate balloon structure with a central lumen and a multiple balloon lumen unit according to an embodiment of the present invention.
FIG. 8 is a schematic view of section A-A corresponding to FIG. 7.
Fig. 9 is a schematic view of a planar traction structure of a capsule unit according to an embodiment of the present invention.
Fig. 10 is a schematic view of one of the balloon units of fig. 9 after compression force adjustment.
Fig. 11 is a schematic structural view of a capsule holder of a capsule unit according to an embodiment of the present invention.
Reference numerals illustrate:
uterine cavity S1, vaginal fornix S2;
a balloon unit distal end P1, a balloon unit proximal end P2;
a high-precision hemostatic bag 100;
Intrauterine hemostatic balloon 111, side balloon connection region 111a, non-connection region 111b, balloon wall 110c, middle balloon 1110, central lumen 1110a, balloon lumen unit 1110b, balloon lumen channel 1110c, pull wire 1110d, balloon lumen stent 1110e, left balloon 1111, left inferior compression region 1111a, right balloon 1112, right inferior compression region 1112a;
An intravaginal fixation balloon 112, an annular balloon body 1121, an inner collar 1122, an inflation port 1123;
Catheter assembly 120, drainage tube 121, drainage port 1211, intrauterine hemostatic balloon tube 122, intravaginal fixed balloon tube 123;
A joint portion 130;
A drainage device 140;
A filling device 150;
an operation bracket 160;
Gap 200.
Detailed Description
The high-precision hemostatic bag and system of the present disclosure will be described in further detail below with reference to the drawings and examples. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be regarded as being isolated, and they may be combined with each other to achieve a better technical effect. In the drawings of the embodiments described below, like reference numerals appearing in the various drawings represent like features or components and are applicable to the various embodiments. Thus, once an item is defined in one drawing, no further discussion thereof is required in subsequent drawings.
It should be noted that the structures, proportions, sizes, etc. shown in the drawings are merely used in conjunction with the disclosure of the present specification, and are not intended to limit the applicable scope of the present invention, but rather to limit the scope of the present invention. The scope of the preferred embodiments of the present invention includes additional implementations in which functions may be performed out of the order described or discussed, including in a substantially simultaneous manner or in an order that is reverse, depending on the function involved, as would be understood by those of skill in the art to which embodiments of the present invention pertain.
Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the authorization specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values.
In the description of the embodiment of the present application, "/" means or, and/or "is used to describe the association relationship of the association object, which means that three relationships may exist, for example," a and/or b "means that a single first and a single second exist, and that a single second exists, and that a single first and a single second exist. In the description of the embodiments of the present application, "plurality" means two or more.
Examples
Referring to fig. 2, a high-precision hemostatic bag 100 is provided for use in uterine cavity hemostasis. The high-precision hemostatic balloon 100 adopts a balloon catheter and mainly comprises a balloon assembly and a catheter assembly, wherein the balloon assembly is arranged on the catheter assembly.
As shown in connection with fig. 3, the balloon assembly may include an intrauterine hemostatic balloon 111 and an intravaginal fixation balloon 112. In particular, the intrauterine blood-stopping balloons and the intravaginal fixation balloons are made of expandable materials, such as natural rubber, synthetic rubber, silicone, latex, polyurethane, polyvinyl chloride, polyethylene, nylon, or any other expandable elastomer, polymer, or other material. Preferably, the intrauterine hemostatic balloon and the intravaginal fixation balloon are made of silicone, which is sufficiently compliant to generally conform to the shape of the uterine cavity.
In this embodiment, the intrauterine hemostatic balloon 111 includes a middle balloon 1110, and a left balloon 1111 and a right balloon 1112 respectively located on the left and right sides of the middle balloon 1110, where the middle balloon 1110, the left balloon 1111 and the right balloon 1112 are combined to form a flat inverted pear shape with a wider upper part and a narrower lower part, and a smaller front-rear diameter than the left-right diameter. The middle balloon 1110 is independent of the cavities of the left balloon 1111 and the right balloon 1112, and when inflation is required, the cavities are filled with fluid through the respective filling pipes. The middle balloon 1110 is inflated to compress the anterior and posterior walls of the uterus, and the left balloon 1111 and the right balloon 1112 are inflated to compress the left and right side walls of the uterus. In particular, the left lower compression zone 1111a of the left balloon 1111 and the right lower compression zone 1112a of the right balloon 1112, after inflation, can effectively compress the ascending branch of the uterine artery of the lower uterine segment to effectively stop bleeding.
As a typical preferred mode, the middle balloon 1110 may be an oval or a substantially oval balloon, the bottom of the left balloon 1111 is attached to the left side of the middle balloon 1110 to form a first connection region, the bottom of the right balloon 1112 is attached to the right side of the middle balloon 1110 to form a second connection region, and the left balloon 1111 and the right balloon 1112 may be axisymmetrically arranged with respect to the middle balloon 1110, where the areas of the first connection region and the second connection region are equal. Optionally, the left balloon 1111 and the right balloon 1112 are relatively flat balloons, and the upper section of the flat balloon is wider than the lower section to form a balloon structure with a wider upper section and a narrower lower section, the upper section compression region may correspond to a uterine angle region, and the lower section compression region may correspond to a uterine artery uplink branch region.
If the horizontal cross section of the middle balloon 1110 is divided into 4 regions, front, rear, left and right, on average, by angle, it is preferable that the first connection region is located in the middle of the left region of the middle balloon and the ratio of the first connection region to the left region is not more than 2/3 so that the left balloon 1111 better presses the left side of the uterine wall when inflated, and the second connection region is located in the middle of the right region of the middle balloon and the ratio of the second connection region to the right region is not more than 2/3 so that the right balloon 1112 better presses the right side of the uterine wall when inflated. For example, if the central angles of the left and right regions in the horizontal cross section are both 90 degrees, the central angles of the first and second connection regions in the horizontal cross section are preferably 2/3 or less of 90 degrees, that is, 60 degrees or less.
The intravaginal fixation balloon 112 is adapted to be secured within the vaginal vault at the vaginal apex and around the cervix (or cervical canal) after inflation, lifting the aforementioned intrauterine hemostatic balloon while closing the endocervical opening. That is, intravaginal fixation balloon 112 is required to form a structure capable of surrounding the cervical canal after inflation.
In a typical embodiment, as shown in connection with fig. 3 and 4, the intravaginal fixation balloon is an annular balloon, resembling the structure of a swim ring. Specifically, the annular intravaginal fixation balloon 112 may include an annular balloon body 1121 for filling a fluid within an interior cavity of the annular balloon body 1121, with the annular balloon body 1121 defining an inner ring 1122, the inner ring 1122 of the annular balloon matching a peripheral dimension of the cervix at the vaginal fornix, with the annular balloon body 1121 matching a dimension of the vaginal fornix, such that the intravaginal fixation balloon, upon inflation, is capable of being secured within the vaginal fornix at the vaginal apex and surrounding the cervix. At least one opening is provided on the annular bladder body 1121 as an inflation port 1123, the inflation port 1123 being adapted to communicate with the intravaginal fixation balloon tube for fluid in the intravaginal fixation balloon tube 123 to enter the lumen of the annular bladder body 1121, thereby inflating the annular bladder body 1121.
In this embodiment, the fluid filled when the intrauterine hemostatic balloon 111 and the intravaginal fixation balloon 112 are inflated may be liquid or gas as required. Preferably, the balloon is inflated by filling with a liquid, such as saline.
The catheter assembly 120 is used to drain the blood pool in the uterine cavity and to inflate and deflate the balloon assembly as described above.
In this embodiment, referring to fig. 5, the catheter assembly 120 may specifically include a flexible drainage tube 121, an intra-uterine blood-stopping balloon tube 122, and an intra-vaginal fixation balloon tube 123.
The distal end of the flexible drainage tube 121 sequentially passes through the inner ring 1122 of the intravaginal fixed balloon 112 and the inner cavity of the intrauterine hemostat 111 and then extends out of the intrauterine hemostat, the distal end of the drainage tube 121 is provided with a drainage port 1211 for draining the hematocrit in the uterine cavity, and the proximal end of the drainage tube can be connected with a drainage device. Preferably, the length of the upper end of the drainage tube extending out of the hemostatic bag in the uterine cavity is 5-15mm.
The intrauterine hemostatic balloon catheter 122 may be provided independently or may be attached to the drainage tube 121. Preferably, the intrauterine hemostatic balloon catheter 122 is attached to the drainage tube 121, and an intrauterine hemostatic balloon catheter lumen may be provided on the drainage tube 121.
The intrauterine hemostatic balloon tube 122 is used to communicate the middle balloon 1110, the left balloon 1111 and the right balloon 1112 with the external inflation device 150. Wherein, for middle balloon 1110, left balloon 1111 and right balloon 1112, separate middle balloon tube, left balloon tube and right balloon tube may be provided, respectively, the distal ends of each balloon tube communicate with the lumen of the corresponding balloon, the proximal ends of each balloon tube may be provided with a valve to open or close the tube orifice, each tube orifice being connected to the aforementioned inflation device. When liquid is required to be filled, the valve is opened (the valve can be opened manually or electrically, and the valve adopts an electric control valve at the moment), then the liquid is input into the balloon pipeline through the filling device, and the liquid enters the corresponding balloon through the balloon pipeline so as to expand the balloon. After the balloon is inflated in place, the valve is closed to close the orifice of the tube and the inflation device can then be removed. When the balloon is required to be taken out in the later period, the liquid of the intrauterine hemostatic balloon is firstly discharged, at the moment, the pipeline opening of the balloon pipeline can be connected with a liquid collecting bag for collecting the liquid, and the valve is opened to open the pipeline opening, so that the liquid in the balloon is discharged into the liquid collecting bag through the balloon pipeline.
The intravaginal fixation balloon catheter 123 may be provided independently or may be attached to the drainage tube 121. Preferably, the intravaginal fixed balloon catheter 123 is attached to the aforementioned drainage tube 121, and at this time, an intravaginal fixed balloon catheter subcavity may be provided on the drainage tube 121.
The intravaginal fixed balloon tube 123 is used for communicating the intravaginal fixed balloon 112 with the external inflation device 150, the distal end of the intravaginal fixed balloon tube 123 is communicated with the inner cavity of the intravaginal fixed balloon 112, and the proximal end of the intravaginal fixed balloon tube 123 may be provided with a valve to open or close the tube orifice, and the tube orifice is connected with the inflation device 150. When liquid is required to be filled, the valve is opened (the valve can be opened manually or electrically, and the valve adopts an electric control valve at the moment), then the liquid is input into the intravaginal fixed balloon pipeline 123 through the filling device, and the liquid enters the intravaginal fixed balloon 112 through the intravaginal fixed balloon pipeline 123 to expand the intravaginal fixed balloon. After the balloon is inflated in place, the valve is closed to close the orifice of the tube and the inflation device can then be removed. When the balloon is required to be taken out in the later period, after the liquid of each balloon of the intrauterine hemostatic balloon 111 flows out, the liquid of the intravaginal fixed balloon 112 is put. At this time, the pipeline mouth of the intravaginal fixed balloon pipeline can be connected with a liquid collecting bag for collecting liquid, the valve is opened to open the pipeline mouth, and the liquid in the intravaginal fixed balloon is discharged into the liquid collecting bag through the balloon pipeline.
More preferably, the balloon wall in this embodiment may include a thickened region (thicker wall) to guide the balloon more inflation toward the thinner region of the balloon wall, taking advantage of the inflation characteristics of the balloon.
Specifically, referring to fig. 6, the wall of the middle balloon 111 may include a side balloon connection region 111a and a non-connection region 111b. The wall thickness of the side balloon connection region 111a is greater than that of the non-connection region 111b, so that the middle balloon is inflated more in the direction of the anterior and posterior walls of the uterus when inflated to achieve that the middle balloon is mainly used to compress the anterior and posterior walls of the uterus.
And, the balloon walls of the left and right side balloons may include a middle balloon-connecting region and a non-connecting region. The wall thickness of the middle balloon connecting area is larger than that of the non-connecting area, so that the left balloon and the right balloon are inflated to the left side and the right side of the uterus respectively when inflated and expanded, and the left balloon and the right balloon are mainly used for pressing the side wall of the uterus. In particular, the left and right side balloons can effectively press the left and right side walls of the lower uterine segment after being inflated, thereby directly blocking the ascending branch of the uterine artery and further effectively stopping bleeding.
In this manner, the balloon's expandability at the junction is limited by thickening the walls of the junction so that the expansion of the balloon is directed to the thinner non-junction region of the walls of each balloon, which upon inflation, appears more pronounced. After the scheme is adopted, the hemostatic balloon in the uterine cavity can expand outwards more when being filled, the middle balloon can better press the front wall and the rear wall of the uterus, the left balloon and the right balloon can better press the left side wall and the right side wall of the uterus to press the ascending branch of the uterine artery, and the problem that the hemostatic effect of the traditional hemostatic balloon on the pair Gong Cebi is poor is well solved.
In another implementation of this embodiment, in order to make finer adjustments to the regional pressure of the hemostatic balloon, a hemostatic balloon that is capable of force adjustment is also provided.
At this time, the middle sacculus adopts the multicavity structure, include a center chamber and around the center chamber is a plurality of sacculus cavity units that radial distribution, cavity mutual independence between each sacculus cavity unit, every sacculus cavity unit all communicates with aforementioned center chamber through the sacculus cavity passageway, and all is provided with the traction wire in every sacculus cavity unit and regard as the dynamics adjustment line of sacculus cavity unit, and the dynamics adjustment unit of sacculus cavity unit has formed hemostatic sacculus this moment. When the catheter is filled with fluid, the fluid enters the central cavity of the middle balloon through the catheter assembly and then enters each balloon cavity unit through the balloon cavity channel. At the same time, the central lumen is capable of passing a catheter assembly.
In specific implementation, the central cavity 1110a of the middle balloon 1110 may be configured as a cylindrical cavity or a spherical cavity. When the central lumen 1110a may be provided as a cylindrical lumen, a plurality of balloon units are arranged around the central lumen in the circumferential direction thereof, which may be passed through by the catheter assembly to protrude out of the uterine cavity hemostatic balloon. When the central cavity 1110a may be provided as a spherical cavity, a plurality of balloon units may be distributed around the central cavity along the spherical surface of the central cavity, and at this time, the upper and lower portions of the central cavity 1110a may be reserved with a catheter passage for the catheter assembly to pass through.
And, in this embodiment, the number of the capsule cells surrounded outside the central cavity 1110a may be set according to the accuracy requirement of the area control. Taking a cylindrical cavity as an example, for example, according to the pressure adjustment requirements of the front position, the rear position, the left position and the right position of the uterine cavity, the number of the capsule cavity units can be 4 so as to respectively correspond to the front position, the rear position, the left position and the right position of the body cavity. Taking a spherical cavity as an example, for example, according to the pressure adjustment requirements of the upper right position, the lower right position, the upper left position and the lower left position of the uterine cavity, the number of the capsule cavity units can be 4 so as to respectively correspond to the upper right position, the lower right position, the upper left position and the lower left position of the body cavity. Of course, the number of the capsule units may be set more, such as 6, 8, etc., according to the division accuracy of the region.
As an example of a typical manner, the present embodiment will be described in detail below using a cylindrical cavity as an example of the center cavity 1110 a.
Referring to fig. 7 and 8, the central lumen 1110a of the intermediate balloon 1110 is a cylindrical lumen extending through the intermediate balloon. The cylindrical cavity has an axial direction, a radial direction, and a circumferential direction, the capsule units 1110b are arranged along the circumferential direction of the central cavity 1110a, and a plurality of capsule units are radially distributed around the periphery of the central cavity 1110a, as shown in fig. 8. At this time, with respect to the central cavity 1110a, each of the balloon units 1110b includes a distal end and a proximal end, the distal balloon unit end P1 is an end far from the central cavity 1110a, the proximal balloon unit end P2 is an end near the central cavity 1110a, and the proximal balloon unit end P2 of the balloon unit 1110b is connected to the central cavity 1110 a. At this time, for each of the capsule units 1110b, the top of the capsule unit 1110b is connected to the top of the central cavity 1110a and the bottom is connected to the bottom of the central cavity 1110a along the axial direction of the cylindrical cavity.
The catheter assembly also includes an operating lumen for the intermediate balloon operating stent 160 to enter the aforementioned central lumen 1110a, which may be disposed on one side of the drain tube with the operating lumen distal end in the central lumen. The middle balloon operation stent 160 has a hollow tube structure which can accommodate a traction wire and has a certain hardness to be used as a support when the balloon catheter adjusts pressure.
The first end of the pulling wire 1110d is connected to the wall of the distal end P1 of the balloon unit, and the second end of the pulling wire 1110d enters the central cavity 1110a after penetrating through the balloon channel 1110c located at the proximal end P2 of the balloon unit, is introduced into the lumen of the intermediate balloon operation support 160 after passing through the central cavity 1110a, and is then led out from the lumen outlet at the lower end of the intermediate balloon operation support 160 to the outside.
When the regional pressure of the balloon needs to be regulated, the user can hold the proximal end of the middle balloon operation support 160 by hand, extend the distal end of the middle balloon operation support 160 to the preset position of the central cavity through the operation cavity, after extending into place, the distal end balloon wall of the corresponding balloon cavity unit is pulled through the traction wire according to the region needing to regulate the pressure, and when the traction wire is pulled, the middle balloon operation support supports the catheter assembly, so that the position of the catheter assembly in a human body is maintained unchanged or basically unchanged.
The traction of the traction wire can be performed manually or electrically.
When manually employed, the user may adjust the distal capsule wall of each capsule unit by pulling on the second end of the lead-out pull wire 1110d, thereby adjusting the regional pressure of the uterine cavity region to which the capsule unit corresponds. At this time, it is preferable to set different visual marks for the traction wires of the capsule unit in different areas, so that the user can intuitively distinguish the area corresponding to each traction wire, for example, the traction wires can adopt different colors.
When the electric mode is adopted, a traction adjusting device can be arranged at the lower end of the middle balloon operation bracket 160, and the second end of the traction wire 1110d is led out from the lumen outlet and then connected to the traction adjusting device. For each capsule unit, a traction operation key or a traction operation area can be arranged on the traction adjustment device, when a user triggers the traction operation key or the traction operation area of one capsule unit, the traction adjustment device controls the second end of the traction wire of the capsule unit to wind so as to pull the far-end capsule wall of the capsule unit, thereby adjusting the regional pressure of the uterine cavity region corresponding to the capsule unit.
By way of example and not limitation, the traction adjustment device may include a housing, a controller and 4 wire reels disposed in the housing, wherein the second end of the traction wire of each balloon unit may be fixed on a rotating shaft of the corresponding wire reel, and an electric motor is disposed on the wire reel as a rotation driver to drive the rotating shaft of the wire reel to rotate in a forward or reverse direction, thereby achieving wire winding or unwinding. The control circuit of the electric motor is connected with the controller and receives the control of the controller. And the shell is also provided with 4 key areas for respectively adjusting the 4 capsule cavity units, and each key area can comprise at least two keys for respectively corresponding to the wire winding operation and the wire unwinding operation of the traction wire.
When the pressure of a certain area of the balloon is required to be regulated, a user triggers a wire collecting button corresponding to the balloon cavity unit through the button area, the controller controls the electric motor of the corresponding wire spool to start according to the triggered wire collecting button, the rotating shaft of the wire spool rotates forward to collect wires, the traction wires are pulled slowly to pull the far-end balloon wall of the balloon cavity unit, and when the area pressure meets the requirement, the user can trigger the wire collecting button again to stop wire collecting. When the area is overstretched, the user can trigger the paying-off key of the capsule cavity unit to control paying-off, so that the pressure of the area can be flexibly adjusted to meet the requirement. The automatic winding and unwinding control of the wire spool can refer to an automatic winding drum/winder in the prior art, and belongs to the prior art, and the automatic winding and unwinding control is not repeated here.
In this embodiment, a traction wire may be disposed in each of the balloon units, and the traction wire performs punctiform traction with the balloon wall at the distal end of the balloon unit. In this case, the wall at the distal end of the balloon unit preferably has a thickened region, to which the first end of the traction wire is connected.
In another implementation of this embodiment, the traction to the capsule unit may also be a planar traction, as shown in fig. 9. At this time, a plurality of traction wires may be disposed in each capsule unit, and planar traction is achieved through the plurality of traction wires and the capsule wall of the distal end P1 of the capsule unit, and the first ends of the plurality of traction wires are respectively connected to different orientations of the capsule wall of the distal end P1 of the capsule unit to form a plane, and a user pulls the second ends of the plurality of traction wires at the same time during traction. Optionally, the second ends of the plurality of traction wires are gathered together to form a gathered end, and the user pulls the gathered end to achieve simultaneous traction of the second ends of the plurality of traction wires. Referring to fig. 10, a balloon wall 110c of a hemostatic balloon forms a gap 200 with a uterine cavity wall after a certain balloon unit is pulled. It should be noted that the above-mentioned gap 200 is not necessary when the area pressure is adjusted, for example, the wall 110c of the hemostatic balloon may still be in contact with the uterine cavity wall when the area pressure at the distal end of a certain balloon unit is reduced.
Referring to fig. 11, in this embodiment, each of the balloon units may further be provided with a balloon stent 1110e capable of being filled with a fluid, and the balloon stent 1110e is supported between the proximal end P2 of the balloon unit and the distal end P1 of the balloon unit after being filled with a fluid.
Preferably, the balloon lumen stent 1110e is sequentially connected by a plurality of independent closed cavities, and may include a first lumen segment, a tail lumen segment and at least one intermediate lumen segment, the first lumen segment is connected with the balloon lumen unit distal end P1 balloon wall, the tail lumen segment is connected with the balloon lumen unit proximal end P2 balloon wall, the intermediate lumen segment is located between the first lumen segment and the tail lumen segment and is in nested connection, and independent catheters are respectively arranged corresponding to the first lumen segment, the tail lumen segment and the intermediate lumen segment. And when filling is needed, filling the head cavity section, the tail cavity section and the middle cavity section with fluid respectively through the respective catheters.
When the compression force of the capsule cavity unit corresponding to the uterine cavity area needs to be reduced, part of fluid in the head cavity section can be released firstly to reduce the pressure of the capsule wall at the far end of the capsule cavity unit, and at the moment, the tail cavity section and the middle cavity section keep a filling state to better support the capsule cavity unit.
More advantageously, when the hemostatic bag needs to be taken out, in order to avoid discomfort of a patient caused by rapid contraction of the bag body of the bag, the fluid in the bag cavity bracket can be released firstly to slowly reduce the compression force of each bag cavity unit, then the fluid in the central cavity is released, and at the moment, the fluid in other areas in the bag cavity unit enters the central cavity along with the bag cavity channel and then is released through the central cavity.
Optionally, pressure sensors may be provided in each of the intrauterine hemostatic balloon and the intravaginal fixation balloon to measure the internal pressure of the pressurizing balloon and monitor the pressure of the pressurizing balloon against the wall of the cavity in real time. Specifically, the pressure measuring structure can be inserted into the interior of the pressurizing balloon through the bracket, and after the pressurizing and the inflating, the internal pressure of the pressurizing balloon is monitored.
Correspondingly, a display mechanism for displaying the pressure value detected by the pressure sensor can be arranged on the proximal end of the catheter assembly, so that a user can check the monitored pressure signal.
In another embodiment of the invention, a hemostatic balloon system is also disclosed. The system includes a hemostatic balloon and a balloon boosting device.
The hemostatic balloon is the high-precision hemostatic balloon, and the catheter assembly of the high-precision hemostatic balloon is a flexible catheter assembly.
The balloon boosting device is detachably connected with the flexible catheter assembly and is used for being attached to or inserted into the flexible catheter assembly to support the catheter assembly when the balloon is placed, so that the intrauterine hemostatic balloon of the hemostatic balloon is guided to be placed into the uterine fundus or the upper uterine cavity section.
Specifically, the balloon boosting device is a guide tube, a guide tube sub-cavity can be arranged on a drainage tube of the catheter assembly for insertion of the guide tube, the hardness of the guide tube is greater than that of the drainage tube of the catheter assembly, the hardness of the guide tube is used for improving the bending resistance and toughness of the balloon catheter, and after the balloon is placed in place, the guide tube can be separated from the catheter assembly to take out the guide tube.
Preferably, the guide tube is provided with graduations for indicating the position of the balloon delivered to the uterine cavity.
In the embodiment, a guide tube attached to or inserted into the drainage tube is used as a support to resist bending when the balloon catheter is placed, so that the balloon catheter is placed conveniently. After the balloon is placed in place, the guide tube can be separated from the drainage tube to remove the guide tube. The guide tube enables the balloon to be placed without tools such as pliers and forceps, the balloon is placed more quickly and accurately, the work of medical staff is reduced, and discomfort of a patient is further reduced. Meanwhile, the guide tube can be flexibly put in or taken out, so that the balloon catheter can keep the original softness, and has a simple structure and strong practicability.
In another implementation of this embodiment, the hemostatic balloon system may further comprise a cervical band, such as a wide nylon band, which is used for horizontal cerclage to close the endocervical opening.
When the cervical ring binding belt is specifically arranged, the cervical ring binding belt is connected to a catheter assembly (such as a drainage tube) of the hemostatic balloon, and is arranged corresponding to the position of the fixed balloon in the vagina. After the hemostatic bag is placed in the uterine cavity, a proper amount of liquid is filled to ensure that the saccule is positioned at the upper section or the uterine bottom of the uterine cavity, then the saccule is clung to fornix in vagina, cervical ring is pricked for one circle as close to the internal opening of cervix as possible to prevent the hemostatic bag from slipping, and then the hemostatic bag is continuously filled until the whole saccule is completely clung to the uterine cavity. The cervical ligation band is directly wound around the cervical, no suture is needed, and the damage to the cervical is reduced. Meanwhile, for postpartum hemorrhage patients after vaginal delivery, such as cervical laceration, the cervical laceration can be stopped after cerclage without stitching.
Preferably, the cervical ring binder comprises a ring binder and a telescopic buckle, and the telescopic buckle can adjust the tightness of the ring binder.
Specifically, flexible buckle can be including having the casing of block through-hole, and the block through-hole transversely runs through inside the casing, the one end of ring tie with flexible buckle's casing fixed connection, the other end of ring tie runs through the block through-hole of casing, the bottom surface of block through-hole inner wall be connected with the rack of ribbon looks block, the top surface recess has been seted up at the central authorities of block through-hole inner wall top surface, and the lower extreme of top surface recess is equipped with and is used for carrying out spacing fixed extrusion piece to the ribbon. When the ribbon is required to be released, the extrusion block is pulled up to release the extrusion of the ribbon, so that the ribbon can freely move in the clamping through hole, and the tightness of the ribbon can be adjusted.
When the uterine cavity hemostatic balloon is used, after the unexpanded uterine cavity hemostatic balloon is placed in the uterine cavity, a proper amount of liquid is filled to ensure that the balloon is positioned at the upper section or the uterine bottom of the uterine cavity, then the cervical ring is pricked in the vagina to be clung to the fornix and as close to the level of the internal opening of the uterine neck as possible so as to prevent the uterine cavity hemostatic balloon from slipping off, then the uterine cavity hemostatic balloon is continuously filled until the whole uterine cavity is completely attached to the uterine cavity, and the circular band is directly ligatured around the uterine neck in a circle without suturing, so that the uterine neck is not damaged. Then, the intravaginal fixed saccule is filled to be clamped and fixed in the vaginal fornix, and the intrauterine hemostatic saccule can be lifted by the intravaginal fixed saccule to strengthen the ring binding belt to close the endocervical opening. Under the dual functions of the ring binding belt and the vaginal fixation saccule, the cervical orifice can be better closed so as to prevent the hemostatic saccule in the uterine cavity from slipping off, and the cervical can be kept or recovered to a normal anatomical structure so as to be beneficial to hemostasis, and meanwhile, the blood accumulation in the uterine cavity is not influenced.
When the hemostatic balloon is taken out, firstly, the liquid of the hemostatic balloon in the uterine cavity is put out, then the liquid of the fixed balloon in the vagina is put out, and finally, the cervical ring binding belt is removed.
Other technical features are described in the previous embodiments and are not described in detail here.
In the above description, the disclosure of the present invention is not intended to limit itself to these aspects. Rather, the components may be selectively and operatively combined in any number within the scope of the present disclosure. In addition, terms like "comprising," "including," and "having" should be construed by default as inclusive or open-ended, rather than exclusive or closed-ended, unless expressly defined to the contrary. All technical, scientific, or other terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Common terms found in dictionaries should not be too idealized or too unrealistically interpreted in the context of the relevant technical document unless the present disclosure explicitly defines them as such. Any alterations and modifications of the present invention, which are made by those of ordinary skill in the art based on the above disclosure, are intended to be within the scope of the appended claims.
Claims (9)
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN205796227U (en) * | 2016-05-24 | 2016-12-14 | 邹明 | It is applied to the foley's tube of Asherman's syndrom curing |
| CN114469229A (en) * | 2022-01-21 | 2022-05-13 | 中南大学湘雅三医院 | Accurate regulation formula uterus hemostasis sacculus device of pressure |
| CN217525252U (en) * | 2022-03-21 | 2022-10-04 | 中山大学附属第三医院 | Uterine cavity hemostatic balloon convenient for transvaginal placement |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2410047C1 (en) * | 2009-11-09 | 2011-01-27 | Общество с ограниченной ответственностью "ГинаМед" | Method of uterine postpartum haemorrhage treatment and double balloon catheter for its implementation |
| US11717325B2 (en) * | 2017-12-03 | 2023-08-08 | Nasser Kamal Abd Elaal | Medicated uterine balloon with cervical barricade for management of postpartum hemorrhage |
| CN214208414U (en) * | 2020-10-21 | 2021-09-17 | 天津市第三中心医院 | A postpartum hemostatic balloon tube assembly |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN205796227U (en) * | 2016-05-24 | 2016-12-14 | 邹明 | It is applied to the foley's tube of Asherman's syndrom curing |
| CN114469229A (en) * | 2022-01-21 | 2022-05-13 | 中南大学湘雅三医院 | Accurate regulation formula uterus hemostasis sacculus device of pressure |
| CN217525252U (en) * | 2022-03-21 | 2022-10-04 | 中山大学附属第三医院 | Uterine cavity hemostatic balloon convenient for transvaginal placement |
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