A vaginal hemostatic plug with compression cold compress and bleeding volume monitoring function and application thereof

Abstract

The present application relates to the technical field of vaginal hemostatic tampon, in particular to a vaginal hemostatic tampon with compression cold compress and bleeding amount monitoring and application thereof, comprising a tampon body assembly, a compression capsule and an external control host; the tampon body assembly is composed of a cannula and a catheter inserted on the central shaft of the cannula; a plurality of backflow pipes are distributed on the circumference of an external section of the catheter for forming a circulating pipeline for circulating cooling medium; a plurality of flexible electrode groups are embedded on the outer wall of the compression capsule at equal intervals, and the external control host is used for providing and driving the cooling medium to circulate in the cannula; and the change of electrical impedance between the electrodes is detected. The double-layer circulating cooling structure composed of the cannula and the catheter is provided to realize cold compress hemostasis in the vagina; the bleeding state is sensed in real time by using the change of electrical impedance caused by the gathering of blood between the electrodes, and the bleeding speed grade is directly indicated to avoid tissue ischemia injury caused by blind excessive compression.

Description

Technical Field

[0001] This invention relates to the field of vaginal hemostatic suppository technology, specifically to a vaginal hemostatic suppository that combines pressure cold compress and bleeding volume monitoring, and its application. Background Technology

[0002] Postpartum or traumatic vaginal tearing and bleeding is a common clinical emergency. Currently, most vaginal tampon hemostatic devices on the market use simple compression or balloon inflation, which have limited functions. This can easily lead to blind compression for hemostasis, making it difficult to achieve hemostasis while minimizing the risk of tissue damage, thus hindering clinical procedures and ensuring clear safety boundaries.

[0003] In the prior art, patent CN209270087U discloses a vaginal tampon for antibacterial and hemostatic purposes. The hemostatic plug includes an inflation mechanism, and the inflation mechanism is externally provided with a support plate, a groove, a support rod, a moving block, a fixed sleeve, a clamping block, a latex tube, a connecting block, a connecting rod, a connecting sleeve, and a threaded sleeve. By rotating the threaded sleeve, the connecting sleeve moves up and down. Under the cooperation of the connecting rod and the connecting block, the distance between the left and right clamping blocks increases or decreases, thereby fixing the latex tube on the fixed sleeve, which facilitates the replacement of the latex tube for multiple uses.

[0004] However, while this existing technology solves the cost problem of reusable hemostatic plugs, its function is limited to hemostasis through air compression of the latex tube. In actual clinical practice, the treatment of vaginal tearing and bleeding often requires a combination of methods—in addition to compression, cold compresses are needed to promote local vasoconstriction and accelerate coagulation. At the same time, there is a lack of real-time means to perceive changes in bleeding volume during hemostasis. Doctors can only rely on experience to judge the hemostatic effect, which can easily lead to premature removal of compression causing rebleeding, or excessive pressure being applied continuously as a precaution, resulting in local tissue ischemia and necrosis.

[0005] Therefore, the existing technologies mentioned above still have obvious shortcomings, such as limited functionality and inability to achieve both cold compress and bleeding monitoring. There is an urgent need for a composite hemostatic device that combines vaginal compression hemostasis, direct cold compress, and real-time bleeding monitoring. Summary of the Invention

[0006] In order to overcome the defects in the prior art, the present invention aims to provide a vaginal hemostatic suppository that combines compression cold compress and bleeding monitoring, and its application. By forming a closed-loop system of cold compress coagulation + segmented compression hemostasis + impedance real-time monitoring hemostasis, the problems mentioned in the background art are solved.

[0007] To achieve the above objectives, the present invention provides a vaginal hemostatic suppository that combines pressure cold compress and bleeding monitoring, comprising a suppository assembly, a pressure bladder covering the suppository assembly, and an external control unit. The embolization assembly consists of an insertion tube and a conduit inserted into its central axis; the conduit and the insertion tube have a cavity, and one end of the conduit extends to the outside of the insertion tube for introducing cooling medium into the insertion tube; a section of the conduit placed on the outside is circumferentially sealed with several return pipes to form a circulation pipeline for circulating the cooling medium. The compression bladder is a cylindrical cavity bladder structure in its natural state and is fitted and sealed to the cannula. One end of the compression bladder is provided with a reservoir bladder with a conical cavity structure. The reservoir bladder is covered by the outer section of the catheter and is used to control the inflation and deflation of the compression bladder. Several bent elastic pieces are fixed on the outer wall of the large diameter section of the reservoir bladder and are used to rebound and drive the reservoir bladder to expand and reset. The outer wall of the compression bladder is embedded with several flexible electrode groups at equal intervals, and the electrode leads of the flexible electrode groups are led out through the wall of the compression bladder. The external control host includes a cooling circulation module and an impedance monitoring module. The cooling circulation module is connected to the outer end of the catheter through a pipeline and is used to provide and drive the cooling medium to circulate in the cannula. The impedance monitoring module is electrically connected to the electrode leads of the flexible electrode groups and is used to detect the change in impedance between the electrodes and display the bleeding rate level through the display unit.

[0008] As a further improvement to this technical solution, the flexible electrode group consists of a pair of excitation electrodes and measurement electrodes.

[0009] As a further improvement to this technical solution, the impedance monitoring module has a preset bleeding threshold; when the impedance decrease measured by the flexible electrode group exceeds the bleeding threshold, the display unit displays bleeding warning information and indicates the bleeding rate level; when the impedance tends to stabilize or rises, the display unit displays hemostasis stabilization information.

[0010] As a further improvement to this technical solution, the compression bladder and the air reservoir are integrally molded from silicone material; the other end of the compression bladder is sleeved with the closed end of the insertion tube and fixed by a sealing sleeve.

[0011] As a further improvement to this technical solution, the outer wall of the compression bladder is provided with several hoop layers at equal intervals, and the wall thickness of the hoop layers is less than the wall thickness of the compression bladder.

[0012] As a further improvement to this technical solution, a pre-tightening sleeve is provided on the connecting section between the compression bladder and the air reservoir, and the pre-tightening sleeve is adapted to fit the insertion tube and the compression bladder as a whole.

[0013] As a further improvement to this technical solution, the outer extension of the catheter is fixedly fitted with a tube sleeve and a return sleeve at intervals. The tube sleeve is tightly fitted with the outer port of the insertion tube, and the return tube is embedded between the tube sleeve and the return sleeve to form a circulation loop for the cooling medium. The outer wall of the return sleeve is connected with several protruding tubes, which are connected to the external control host through pipelines.

[0014] As a further improvement to this technical solution, the refrigeration cycle module includes a temperature sensor and a peristaltic pump box. The temperature sensor detects the temperature of the cooling medium returning from the return sleeve. The refrigeration cycle module automatically adjusts the pumping rate of the cooling medium by the peristaltic pump according to the difference between the return water temperature and the preset target temperature, thereby realizing closed-loop control of the cooling temperature.

[0015] As a further improvement to this technical solution, a fixing sleeve is fixedly provided at the small diameter end of several of the spring pieces, and the fixing sleeve is tightly fitted with the return sleeve.

[0016] This invention provides a vaginal hemostatic suppository that combines pressure cold compress and bleeding monitoring, and is used for hemostasis in clinical gynecological surgery.

[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. This vaginal hemostatic suppository, which combines compression cold compress and bleeding monitoring, and its application, utilizes a double-layer circulating cooling structure consisting of a cannula and a catheter. This allows the cooling medium to flow directly within the cannula for heat exchange, and the cooling energy is efficiently transferred to the compression bladder and the vaginal wall contact surface through the 316L stainless steel tube wall. This achieves direct cold compress hemostasis for vaginal lacerations, solving the clinical problem that existing products can only provide surface cold compresses and cannot penetrate deep into the vagina.

[0018] 2. This vaginal hemostatic plug, which combines compression and cold compress with bleeding monitoring, features a flexible electrode array embedded at equal intervals on the outer wall of the compression sac. It uses the decrease in impedance caused by blood pooling between the electrodes during bleeding to detect the bleeding status in real time. The original impedance signal is converted into an intuitive indication of the bleeding rate level through preset thresholds and graded displays. This allows medical staff to quickly judge the hemostatic effect without continuous observation, enabling precise gas replenishment and compression as needed, and avoiding tissue ischemia and damage caused by blindly applying excessive pressure.

[0019] 3. This vaginal hemostatic suppository, which combines pressure cold compress and bleeding monitoring, detects the return water temperature through a built-in temperature sensor in the cooling circulation module. After comparing it with the preset target temperature, it automatically adjusts the pumping rate of the peristaltic pump to achieve closed-loop precise control of the cold compress temperature. This ensures that the temperature of the vaginal contact surface is maintained within a safe range, avoiding ineffective cold compresses due to excessively high temperatures or frostbite to the mucosa due to excessively low temperatures. This significantly improves treatment safety and patient comfort.

[0020] 4. This vaginal hemostatic suppository, which combines compression and cold compress with bleeding monitoring, and its application, through the combined design of the air reservoir, spring, and pre-tightening sleeve, allows for a complete operation of squeezing and inflating with one hand, and automatic rebound when released. The outer wall of the compression bladder is equipped with a thinned hoop layer, which expands first during inflation to form a segmented compression band, achieving a concentrated compression effect similar to multiple tourniquets. It is convenient to operate and more efficient in stopping bleeding. Attached Figure Description

[0021] The accompanying drawings described herein are for illustrative purposes only. The shapes and proportions of the components in the drawings are merely schematic and intended to aid in understanding the invention. They are not intended to specifically limit the shapes and proportions of the components of the invention.

[0022] Figure 1 This is a front view of the overall structure of the present invention; Figure 2 This is a schematic diagram of the overall cross-sectional structure of the present invention; Figure 3 For the present invention Figure 2 The main view; Figure 4 This is an exploded view of the plug assembly of the present invention; Figure 5 This is a schematic diagram of the full-section structure of the catheter of the present invention; Figure 6 This is a schematic diagram of the compression bladder structure of the present invention; The meanings of the labels in the diagram are as follows: 100. Embolization assembly; 110. Catheter; 111. Sealing sleeve; 120. Catheter; 121. Tube sleeve; 122. Return sleeve; 130. Return tube; 200. Compression bladder; 201. Hoop layer; 210. Air reservoir; 220. Pre-tightening sleeve; 230. Flexible electrode assembly; 240. Spring; 241. Fixing sleeve. Detailed Implementation

[0023] The specific embodiments described herein are for illustrative purposes only. Under the guidance of this invention, any possible variations of the invention by those skilled in the art should be considered within its scope. The directional terms used herein are based on the orientations shown in the accompanying drawings and are for ease of description and simplification; therefore, they should not be construed as limitations on the invention. Furthermore, in the description of this invention, "a number" means two or more, unless otherwise explicitly specified.

[0024] Please see Figures 1-6 As shown, the present invention provides a vaginal hemostatic plug that combines pressure cold compress and bleeding monitoring, which is used for hemostasis in clinical gynecological surgery; it includes a plug body component 100, a pressure bladder 200 covering the plug body component 100, and an external control host.

[0025] Specifically, the plug assembly 100 consists of a cannula 110 and a catheter 120 inserted into its central axis; the outer diameter of the cannula 110 is 5-8 mm, preferably 6 mm, to fit and smoothly insert into the vagina; the cannula 110 is made of medical-grade 316L stainless steel, which can efficiently achieve full-section heat exchange and avoid local overcooling; a cavity is left between the catheter 120 and the cannula 110, that is, the outer diameter of the catheter 120 is smaller than the inner diameter of the cannula 110, thereby forming a circulation channel; one end of the catheter 120 extends to the outside of the cannula 110 for introducing cooling medium into the cannula 110; a circumferentially sealed section of the catheter 120 is provided with several return pipes 130 to form a circulation pipeline for the circulation of cooling medium.

[0026] Furthermore, the extended section of the conduit 120 is fixedly fitted with a sleeve 121 and a return sleeve 122 at intervals. The sleeve 121 is tightly fitted with the outer port of the insertion tube 110 to seal the insertion tube 110. The return pipe 130 is embedded between the sleeve 121 and the return sleeve 122 to form a circulation loop for the cooling medium. The outer wall of the return sleeve 122 is connected with several protruding pipes, which are connected to the external control host through pipelines. The cooling medium is pumped into the inner cavity of the insertion tube 110 through the pipelines and conduit 120 by the external control host, and then flows back to the external control host through several return pipes 130 and pipelines to form a circulating cooling channel.

[0027] The external control unit includes a cooling circulation module, which is connected to the outer end of the conduit 120 via a pipeline to provide and drive the cooling medium to circulate within the insertion tube 110. The cooling circulation module includes a temperature sensor and a peristaltic pump box, which consists of a peristaltic pump and a cooling medium storage tank, and is cooled by installing a semiconductor cooling chip. The temperature sensor detects the temperature of the cooling medium returning from the return sleeve 122. The cooling circulation module automatically adjusts the pumping rate of the cooling medium by the peristaltic pump according to the difference between the return water temperature and the preset target temperature, thereby achieving closed-loop control of the cold compress temperature.

[0028] By detecting the return water temperature, a closed-loop control of the cold compress temperature can be achieved, which can accurately maintain the cold compress temperature of the vaginal contact surface within a preset safe range, avoiding insufficient cold compress effect due to excessively high temperature or frostbite of the mucosa due to excessively low temperature, thus improving the safety and comfort of treatment.

[0029] Specifically, the compression bag 200 has a cylindrical cavity structure in its natural state and is fitted and sealed to the cannula 110. One end of the compression bag 200 is provided with a conical cavity structure air reservoir 210, which is covered by the extension section of the catheter 120 and is used to control the inflation and deflation of the compression bag 200. Several bent spring pieces 240 are fixed on the outer wall of the large diameter section of the air reservoir 210. The spring pieces 240 are made of spring steel and have a bent structure. By squeezing the air reservoir 210, the compression bag 200 is inflated and expanded to compress the vaginal wall to stop bleeding. After releasing the hand, the spring pieces 240 rebound and cause the air reservoir 210 to expand and return to its original position, thus deflating the compression bag 200 under negative pressure for removal. It is very convenient to operate with one hand.

[0030] A number of spring clips 240 are fixedly fitted with fixing sleeves 241 at their small-diameter ends. The fixing sleeves 241 are tightly fitted with the return sleeves 122. The compression bladder 200 and the air reservoir 210 are integrally molded from silicone material. The other end of the compression bladder 200 is fitted with the closed end of the insertion tube 110 and fixed by a sealing sleeve 111. This forms a sealed state between the compression bladder 200 and the air reservoir 210 and the plug assembly 100, allowing gas to flow inside the air reservoir 210 and the compression bladder 200 to complete the inflation and deflation.

[0031] Furthermore, the outer wall of the compression bladder 200 is provided with several equally spaced hoop layers 201, and the wall thickness of the hoop layers 201 is less than the wall thickness of the compression bladder 200; this allows it to form an expansion ring first when inflated, dividing the compression bladder 200 into multiple compression zones for segmented hemostasis. A pre-tightening sleeve 220 is fitted onto the connection section between the compression bladder 200 and the reservoir bladder 210, and the pre-tightening sleeve 220 is integrally fitted with the cannula 110 and the compression bladder 200, so that after the reservoir bladder 210 is deflated, the pre-tightening sleeve 220 prevents the compression bladder 200 from deflating, freeing up the hands for other operations.

[0032] In addition, a number of flexible electrode groups 230, preferably flexible electrode strips, are embedded at equal intervals on the outer wall of the compression bladder 200; the flexible electrode group 230 consists of paired excitation electrodes and measuring electrodes. The electrode leads of the flexible electrode group 230 are led out through the wall of the compression bladder 200; the external control host also includes an impedance monitoring module, which is electrically connected to the electrode leads of the flexible electrode group 230, and is used to detect the change in impedance between the electrodes and display the bleeding rate level through the display unit.

[0033] The impedance monitoring module has a preset bleeding threshold. When the decrease in impedance measured by the flexible electrode group 230 exceeds the bleeding threshold, the display unit displays a bleeding warning and indicates the bleeding rate level. When the impedance tends to stabilize or rises, the display unit displays hemostasis stability information. The preset threshold and graded display design transforms the original impedance signal into intuitive clinical indication information, allowing medical staff to quickly judge the hemostasis status without continuous observation or professional knowledge. By adjusting the size of the squeezing air reservoir 210, air can be replenished, reducing the burden of clinical monitoring and enabling timely detection of bleeding changes to avoid delays in treatment.

[0034] The vaginal hemostatic suppository of the present invention, which combines compression cold compress and bleeding monitoring, is used by inserting the suppository assembly 100 into the patient's vagina, thereby placing the compression bladder 200 into the vagina; by squeezing the air reservoir 210 to inflate the compression bladder 200, the vaginal wall is compressed to stop bleeding; the external control host is activated to pump the cooling medium into the lumen of the cannula 110 through the tubing and catheter 120, and then back to the external control host through several return tubes 130 and tubing, forming a circulating cooling system to apply cold compress to the vaginal wall; in addition, based on the bleeding status detected by the impedance monitoring module through the flexible electrode group, the impedance change of the flexible electrode group is continuously monitored. When the display unit shows hemostasis stability information, the pre-tightening sleeve 220 is put into the cannula 110 to maintain the current inflation pressure and cold compress temperature; when the bleeding warning information is displayed, the air reservoir 210 is squeezed to adjust the inflation pressure and / or cold compress parameters until hemostasis is stable.

[0035] It should be noted that the above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A vaginal hemostatic suppository that combines pressure cold compress and bleeding monitoring, characterized in that: It includes an embolization assembly (100), a compression bag (200) covering the embolization assembly (100), and an external control unit; The embolus assembly (100) consists of an insertion tube (110) and a conduit (120) inserted into its central axis; the conduit (120) and the insertion tube (110) have a cavity, and one end of the conduit (120) extends to the outside of the insertion tube (110) for introducing cooling medium into the insertion tube (110); a section of the conduit (120) placed on the outside is circumferentially sealed with several return pipes (130) to form a circulation pipeline for circulating cooling medium; The compression bladder (200) is a cylindrical cavity bladder structure in its natural state and is fitted and sealed to the cannula (110). One end of the compression bladder (200) is provided with a reservoir bladder (210) with a conical cavity bladder structure. The reservoir bladder (210) is covered by the outer extension of the catheter (120) and is used to control the inflation and deflation of the compression bladder (200). Several bent elastic pieces (240) are fixed on the outer wall of the large diameter section of the reservoir bladder (210) for rebound to drive the reservoir bladder (210) to expand and reset. The outer wall of the compression bladder (200) is provided with a plurality of flexible electrode groups (230) at equal intervals, and the electrode leads of the flexible electrode groups (230) are led out through the wall of the compression bladder (200); the external control host includes a cooling cycle module and an impedance monitoring module. The cooling cycle module is connected to the outer end of the catheter (120) through a pipeline and is used to provide and drive the cooling medium to circulate in the insertion tube (110); the impedance monitoring module is electrically connected to the electrode leads of the flexible electrode groups (230) and is used to detect the change in impedance between the electrodes and display the bleeding rate level through the display unit.

2. The vaginal hemostatic suppository that combines pressure cold compress and bleeding monitoring according to claim 1, characterized in that: The flexible electrode group (230) consists of a pair of excitation electrodes and measurement electrodes.

3. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 2, characterized in that: The impedance monitoring module has a preset bleeding threshold; when the impedance decrease measured by the flexible electrode group (230) exceeds the bleeding threshold, the display unit displays bleeding warning information and indicates the bleeding rate level; when the impedance tends to stabilize or rises, the display unit displays hemostasis stabilization information.

4. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 3, characterized in that: The compression bladder (200) and the air reservoir (210) are integrally molded from silicone material; the other end of the compression bladder (200) is fitted with the closed end of the insertion tube (110) and fixed by a sealing sleeve (111).

5. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 4, characterized in that: The outer wall of the compression bladder (200) is provided with several hoop layers (201) at equal intervals, and the wall thickness of the hoop layer (201) is less than the wall thickness of the compression bladder (200).

6. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 5, characterized in that: The connection section between the compression bladder (200) and the air reservoir (210) is fitted with a pre-tightening sleeve (220), and the pre-tightening sleeve (220) is integrally fitted with the cannula (110) and the compression bladder (200).

7. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 6, characterized in that: The outer extension of the catheter (120) is fixedly fitted with a sleeve (121) and a return sleeve (122) at intervals. The sleeve (121) is tightly fitted with the outer port of the insertion tube (110). The return tube (130) is embedded between the sleeve (121) and the return sleeve (122) to form a circulation loop of the cooling medium. The outer wall of the return sleeve (122) is connected with several protruding tubes, which are connected to the external control host through the pipeline.

8. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 7, characterized in that: The refrigeration cycle module includes a temperature sensor and a peristaltic pump box. The temperature sensor detects the temperature of the cooling medium returning from the return sleeve (122). The refrigeration cycle module automatically adjusts the pumping rate of the cooling medium by the peristaltic pump according to the difference between the return water temperature and the preset target temperature, so as to realize closed-loop control of the cold compress temperature.

9. The vaginal hemostatic suppository with both pressure cold compress and bleeding monitoring functions as described in claim 8, characterized in that: A fixing sleeve (241) is fixedly provided at the small diameter end of several of the spring pieces (240), and the fixing sleeve (241) is tightly fitted with the return sleeve (122).

Images