Hysteroscope water leakage prevention device and use method thereof

Through the combined structure of the inner and outer tubes, the sealing component is used to close the uterine cavity mouth, which solves the problem of uterine fluid outflow during hysteroscopy, realizes the smooth insertion and position adjustment of the hysteroscopy, improves the examination effect and simplifies the removal of lesion tissue.

CN119548223APending Publication Date: 2025-03-04ANHUI PROVINCIAL HOSPITAL
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Patent Information

Application Number
CN202411801821.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-09
Publication Date
2025-03-04

AI Technical Summary

Technical Problem

During the hysteroscopy, due to the small internal space of the uterus, the uterine fluid is prone to flow out of the cervical mouth, resulting in insufficient visual field of the uterine cavity and reduced examination effect. In addition, existing water leakage prevention devices are blocked by water capsules, making it difficult to insert and position adjustment of hysteroscopy.

Method used

The combined structure of the inner tube and the outer tube is adopted. The inner tube is inserted into the uterine cavity and does not move. The outer tube is opened and fits into the inner wall of the uterine cavity through a sealing component to seal the uterine cavity mouth to prevent the uterine fluid from flowing out, and at the same time, the insertion and position adjustment of the hysteroscopy are allowed.

Benefits of technology

Effectively prevent the uterine fluid from flowing out, improve the visual field of the uterine cavity, simplify the insertion and position adjustment of hysteroscopy, reduce damage to the cervix, and simplify the removal process of lesion tissue.

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Abstract

The invention relates to the technical field of medical instruments, in particular to a hysteroscope water leakage prevention device and a using method thereof.The hysteroscope water leakage prevention device comprises an inner tube and an outer tube, the inner tube and the outer tube are coaxially connected in a sliding mode, and the same side ends of the inner tube and the outer tube are connected with a sealing assembly. When the sealing device is used, the inner tube is inserted into the uterine cavity, the outer tube is pushed to slide towards the end where the sealing assembly is installed, and the sealing assembly can be gradually opened and finally attached to the inner wall of the uterine cavity, so that the uterine cavity opening is closed, and uterine distention liquid cannot flow out; uterine distention liquid perfusion, hysteroscope insertion and hysteroscope position adjustment in a uterine cavity are facilitated, the situation that follow-up hysteroscope insertion and position adjustment cannot be achieved due to the fact that a water bag is used for blocking the uterine cavity is avoided, meanwhile, cut focus tissue is put into the sealing assembly, wraps the focus tissue when the sealing assembly is closed, and is taken out along with the device, and therefore the sealing effect is improved. And the process of taking out the cut focus point tissue is simplified.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a hysteroscope water leakage prevention device and a use method thereof. Background Art

[0002] Hysteroscopy is a new, minimally invasive gynecological diagnosis and treatment technology. It is a fiber-light endoscope used for intrauterine examination and treatment. It includes a hysteroscope, an energy system, a light system, a perfusion system and an imaging system. It uses the front part of the scope to enter the uterine cavity and has a magnifying effect on the observed area. In the process of gynecological examination and treatment of intrauterine diseases, it has become the preferred diagnosis and treatment method for gynecological hemorrhagic diseases and intrauterine lesions because of its intuitive and accurate characteristics.

[0003] During hysteroscopy, due to the small space inside the uterus, in order to facilitate the inspection of the detection head and the operation in the uterine cavity, the perfusion system is usually required to continuously perfuse the uterus with distending fluid to fill the uterus, increase the visual range of medical staff, and facilitate the operation in the uterine cavity. Due to the characteristics of female reproductive organs, the cervical opening has a certain degree of expansibility, which causes the fluid in the uterine cavity to flow out of the cervical opening, resulting in insufficient vision of the uterine cavity and reduced inspection results; the distending fluid that flows out will contaminate the operator's clothes, and if the cervical clamp is used to clamp the cervix, it will cause certain damage to the cervix.

[0004] There are many existing technologies for hysteroscopic water leakage prevention devices, such as:

[0005] Chinese patent publication number CN215821014U discloses a hysteroscope anti-leakage device, including a fixing ring, which is detachably sleeved on the outer periphery of the hysteroscope, and a water-stop bag is provided on the outer ring of the fixing ring. The water-stop bag is bowl-shaped when filled, and the shape and size of the water-stop bag in the filled state match the shape and size of the cervix. A liquid filling tube is provided on the water-stop bag, and a one-way valve is detachably provided at the end of the liquid filling tube.

[0006] It can be seen that most hysteroscopic anti-leakage devices prevent the uterine distension fluid from leaking out by filling a water bag with water so that the water bag expands and fits into the uterine cavity. However, the water bag prevents the uterine distension fluid from leaking out and also completely blocks the cervical opening, making it impossible to achieve subsequent hysteroscopic insertion and position adjustment. At the same time, the water bag is originally made of soft material, and its shape is not fixed even after being filled with water. Therefore, it is unknown whether the use of the water bag can achieve a complete blocking effect.

[0007] In view of this, we propose a hysteroscope anti-leakage device and a method of using the same. Summary of the invention

[0008] The purpose of the present invention is to provide a hysteroscope anti-leakage device and a method of using the same to solve the problems raised in the above-mentioned background technology.

[0009] To achieve the above object, the present invention provides the following technical solutions:

[0010] A hysteroscope anti-leakage device comprises an inner tube and an outer tube, the inner tube and the outer tube are coaxially slidably connected, and the same side ends of the inner tube and the outer tube are connected with a sealing assembly, wherein the inner tube is inserted into the uterine cavity and does not move, and the outer tube is pushed to slide toward the end where the sealing assembly is installed, so that the sealing assembly is opened and fits against the inner wall of the uterine cavity.

[0011] As a further solution of the present invention: the sealing assembly includes a plurality of open plates, and elastic membranes are fixedly connected between adjacent open plates.

[0012] As a further solution of the present invention: a rubber sleeve is fixed to one end of the outer tube, and the same side ends of the opening plate and the elastic membrane are fixed to one side of the rubber sleeve.

[0013] As a further solution of the present invention: a tapered insertion end is fixed at one end of the inner tube.

[0014] As a further solution of the present invention: a fixing ring is fixed at the connection between the insertion end and the inner tube, and a connecting rod is rotatably connected between the fixing ring and the opening plate.

[0015] As a further solution of the present invention: a fixing device is rotatably arranged on the outer side of the inner tube.

[0016] A method for using a hysteroscope water leakage prevention device, applicable to the above-mentioned hysteroscope water leakage prevention device, comprises the following steps:

[0017] S1. After the cervix is ​​softened, insert the insertion end into the cervical opening;

[0018] S2, rotating the fixator to make it fit the outer tube, pushing the outer tube upward, and the opening plate and elastic membrane are opened and fit the inner wall of the cervix, and uterine cavity surgery is performed;

[0019] S3. After the operation, the fixator is rotated in the opposite direction, the outer tube is moved downward, and the plate and elastic membrane are opened to reposition and wrap the resected lesion tissue;

[0020] S4. Separate the fixator from the outer tube, pull the outer tube to the limit position, and then remove the entire device from the cervical opening.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. In the hysteroscope anti-leakage device, by inserting the inner tube into the uterine cavity and keeping it still, pushing the outer tube to slide toward the end where the sealing component is installed, the sealing component will gradually open and finally fit the inner wall of the uterine cavity, thereby closing the uterine cavity opening and preventing the uterine distension fluid from flowing out. By utilizing the inner tube, it is convenient to infuse the uterine distension fluid, insert the hysteroscope, and adjust the position of the hysteroscope in the uterine cavity, avoiding the use of a water bag to block the uterine cavity, which makes it impossible to achieve subsequent hysteroscope insertion and position adjustment.

[0023] 2. In the hysteroscopic anti-leakage device, the cut lesion tissue is placed in the sealing component, and when the sealing component is closed, the lesion tissue is wrapped and taken out with the device, which simplifies the process of removing the cut lesion tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 The overall structural contraction diagram of this scheme

[0025] Figure 2 A schematic diagram is provided for the overall structure of this scheme;

[0026] Figure 3 This is a schematic diagram of the structural section of this scheme.

[0027] The meaning of each number in the figure is:

[0028] 100, inner tube; 101, fixing ring; 102, fixer; 110, insertion end;

[0029] 200, outer tube; 201, rubber sleeve;

[0030] 300, sealing assembly; 301, opening plate; 302, elastic membrane; 303, connecting rod. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Example

[0033] At present, most hysteroscopic anti-leakage devices prevent the uterine distension fluid from flowing out by filling a water bag with water so that the water bag expands and fits into the uterine cavity. However, the water bag blocks the uterine distension fluid from flowing out and also completely blocks the cervical opening, making it impossible to achieve subsequent hysteroscopic insertion and position adjustment. At the same time, the water bag is originally made of soft material, and its shape is not fixed even after being filled with water. It is unknown whether the water bag can achieve a complete blocking effect.

[0034] Therefore, see Figure 1 and Figure 2 As shown, the purpose of this embodiment is to provide a hysteroscope anti-leakage device, which includes an inner tube 100 and an outer tube 200, the inner tube 100 and the outer tube 200 are coaxially slidably connected, and the same side ends of the inner tube 100 and the outer tube 200 are connected with a sealing assembly 300, wherein the inner tube 100 is inserted into the uterine cavity and does not move, and the outer tube 200 is pushed to slide toward one end where the sealing assembly 300 is installed, so that the sealing assembly 300 is opened and fits the inner wall of the uterine cavity.

[0035] The improvement of this embodiment is that: by inserting the inner tube 100 into the uterine cavity and not moving it, the outer tube 200 is pushed to slide toward the end where the sealing assembly 300 is installed, and the sealing assembly 300 will gradually open and finally fit the inner wall of the uterine cavity, thereby closing the uterine cavity opening and preventing the uterine distension fluid from flowing out. By using the inner tube 100, it is convenient to perfuse the uterine distension fluid, insert the hysteroscope, and adjust the position of the hysteroscope in the uterine cavity, avoiding the use of a water bag to block the uterine cavity, which makes it impossible to insert and adjust the position of the hysteroscope later.

[0036] At the same time, the inner tube 100 is made of titanium alloy and can be designed in various models according to different patients. The titanium alloy material itself has excellent properties such as light weight, strong plasticity, good weldability, and non-toxicity, making the inner tube 100 made of titanium alloy suitable for intrauterine surgery; the outer tube 200 is a medical rubber tube, which has no irritation to human tissue and has good sealing, and can ensure the waterproof effect of the device.

[0037] See also Figure 3 As shown, since the cervical opening needs to be completely sealed, leaving only the inner tube 100 as the only passage, the sealing assembly 300 includes a plurality of opening plates 301, and elastic membranes 302 are fixedly connected between adjacent opening plates 301; when the sealing assembly 300 is pushed to open, the opening plates 301 act as a skeleton to drive the elastic membranes 302 to open gradually, and while opening, since the overall structure changes from contraction to expansion, the elastic membrane 302 itself changes from a concave shape to a convex shape, acting as a connecting expansion piece of the entire structure, and the elastic membrane 302 02 A polymer elastic film 302 or a medical silicone material is selected, which has good elasticity and is harmless to human tissue, and can further ensure the water-proof function of the device. At the same time, the edge of the opening plate 301 can be in a variety of shapes such as an outer arc shape, an inner arc shape, a corrugated shape, etc., so as to increase the stability of the device fixed in the cervix when the opening plate 301 is opened and embedded in the inner wall of the cervix; in addition, the number of opening plates 301 and elastic membranes 302 selected in this embodiment is four, and the opening plates 301 and the elastic membranes 302 are arranged around the inner tube 100 as the center of the circle.

[0038] Since the end where the opening plate 301 and the elastic membrane 302 are connected must rotate when opening, a rubber sleeve 201 is fixed to one end of the outer tube 200, and the same side ends of the opening plate 301 and the elastic membrane 302 are fixed to one side of the rubber sleeve 201; the opening plate 301 and the elastic membrane 302 are fixed to one side of the rubber sleeve 201. Compared with the traditional rotation connection, the elasticity of the rubber sleeve 201 can not only ensure the smooth rotation of the opening plate 301 and the elastic membrane 302, but also make the sleeve body composed of the opening plate 301, the elastic membrane 302 and the rubber sleeve 201 closed to prevent the outflow of uterine distension fluid; considering that the rubber sleeve 201 is easy to turn outward when opening, the shape of the rubber sleeve 201 is a stepped cone. Through the stepped and conical design, the rubber sleeve 201 can be evenly stressed along the direction of the cone when subjected to external force, and each stepped part can play a supporting role, thereby reducing the possibility of eversion.

[0039] Taking into account the need to push the opening plate 301 to open, a fixing ring 101 is fixed at the connection between the insertion end 110 and the inner tube 100, and a connecting rod 303 is rotatably connected between the fixing ring 101 and the opening plate 301. When the outer tube 200 slides toward one end where the sealing assembly 300 is installed, the connecting rod 303 is rotated to push the opening plate 301 to open. When the rubber sleeve 201 is against the fixing ring 101, the opening plate 301 expands to its maximum. When the outer tube 200 pulls the opening plate 301 to contract through the connecting rod 303, the rubber sleeve 201 is also driven to recover, so as to prevent the rubber sleeve 201 from everting outward and being difficult to recover, which makes it difficult to remove the entire device from the cervix. The connecting rod 303 is made of carbon fiber material, and the fatigue resistance, high strength and high hardness of the carbon fiber material are utilized to reduce the frequency of maintenance and replacement and reduce costs.

[0040] Considering that the cervical opening is not very large, in order to facilitate the insertion of the inner tube 100, a tapered insertion end 110 is fixed at one end of the inner tube 100. Through the tapered design, when the inner tube 100 is inserted into the cervical opening, the inner tube 100 can smoothly bring the sealing assembly 300 into the cervix. It should be noted that the inner tube 100 cannot be too long so as not to obstruct the surgical field of view; the opening of the insertion end 110 can ensure the entry and exit of the hysteroscope sheath.

[0041] Considering that during the operation, a doctor is required to fix the outer tube 200 specifically to keep the sealing assembly 300 in an open state, this situation will actually cause a waste of human resources. Therefore, the outer wall of the inner tube 100 is provided with a thread, and a fixer 102 is provided to be rotatably connected to the thread. By rotating the fixer 102, the position of the fixer 102 on the inner tube 100 is adjusted, and the fixer 102 will also push the outer tube 200 to move, so that the sealing assembly 300 is opened. When the fixer 102 stops rotating, due to the self-locking property of the thread, the position of the fixer 102 will not be changed by the elasticity of the elastic membrane 302 after the fixer 102 stops rotating, so that the sealing assembly 300 is always kept in an open state, saving human resources. In order to facilitate the rotation of the fixer 102, the fixer 102 is symmetrically fixed with handles, so that it is convenient for medical staff to apply force.

[0042] After the lesion point is removed by the hysteroscopic electrosurgical resection instrument, the removed lesion point tissue needs to be removed from the uterus to prevent the tissue from sticking to the uterine wall. The existing surgical plan often uses operating forceps. After the lesion point tissue is removed, the removed lesion point tissue is clamped out with operating forceps. The operation is repeated until all the removed lesion point tissues are clamped out, which is relatively cumbersome. Considering that after the lesion point tissue is removed, it will sink to the lowest point of the uterus due to gravity. Therefore, it is only necessary to change the patient's position during the operation so that the removed lesion point tissue falls into the sealing surface formed by the opening plate 301, the elastic membrane 302 and the rubber sleeve 201. During the closing process of the sealing component 300, the opening plate 301, the elastic membrane 302 and the rubber sleeve 201 will wrap the removed lesion point tissue, and then the removed lesion point tissue is taken out synchronously with the entire device, simplifying the removal process of the cut lesion point tissue.

[0043] This embodiment also provides a method for using the hysteroscope water leakage prevention device, which is applicable to the hysteroscope water leakage prevention device in the above embodiment, and includes the following steps:

[0044] S1. After the cervix is ​​softened, the insertion end 110 is inserted into the cervical opening;

[0045] S2, rotating the fixator 102 to make it fit the outer tube 200, pushing the outer tube 200 upward, and the opening plate 301 and the elastic membrane 302 are opened and fit the inner wall of the cervix, and the uterine cavity surgery is performed;

[0046] S3, after the operation is completed, the fixator 102 is rotated in the reverse direction, the outer tube 200 is moved downward, and the opening plate 301 and the elastic membrane 302 are reset and wrap the resected lesion tissue;

[0047] S4, separate the fixator 102 and the outer tube 200, pull the outer tube 200 to the limit position, and then remove the entire device from the cervical opening.

[0048] In summary, the working principle of this solution is as follows:

[0049] Before the operation, since the non-pregnant cervical canal is narrow and tough and difficult to dilate, there is a possibility of serious complications such as difficulty in cervical dilation, failure of endoscopic placement, cervical laceration, and even uterine perforation or air embolism for patients who have not given birth, have a history of cervical surgery, or are menopausal. Therefore, drugs or mechanical methods are first used to intervene in the non-pregnant cervix to change its tissue structure, relax and soften it, and make it easy to dilate, so that the device can enter and exit the uterine cavity without resistance; among them, the drug pretreatment method is to use phloroglucinol injection for intravenous or intramuscular administration, usually intravenous drip, with a dose of 40-80 mg, and multiple injections can be performed on the cervix for patients with extremely tough cervical tissue; the mechanical pretreatment method is a hydrophilic cervical dilator or a simple cervical dilator to stimulate and change the physical and chemical properties of the cervical canal to soften the cervix; after the cervix softens, hysteroscopic surgery can be performed;

[0050] During the operation, the insertion end 110 of the inner tube 100 is first aligned with the cervical opening and inserted, so that the entire sealing assembly 300 enters the cervix, and the fixture 102 is rotated clockwise, so that the fixture 102 pushes the outer tube 200, so that the outer tube 200 slides toward the end where the sealing assembly 300 is installed. At this time, the connecting rod 303 rotates and pushes the opening plate 301 to open, and when the opening plate 301 opens, it drives the elastic membrane 302 to open, until the opening plate 301 and the elastic membrane 302 are opened. The elastic membrane 302 is attached to the inner wall of the cervix, and then the hysteroscope sheath is inserted into the cervix through the inner tube 100, the uterine cavity perfusion system is turned on, and after the uterine distension fluid is filled into the cervix through the hysteroscope sheath, the lighting system and the camera and imaging system are turned on, and the position of the hysteroscope sheath in the cervix is ​​adjusted to find the lesion point, and the lesion point is removed by the hysteroscope electrosurgical resection instrument, and the tissue of the lesion point to be removed is waited to fall into the sealing surface formed by the opening plate 301, the elastic membrane 302 and the rubber sleeve 201;

[0051] After completing all surgical operations, first remove the hysteroscope sheath from the inner tube 100, rotate the fixture 102 counterclockwise, and the fixture 102 will move away from one end of the sealing component 300. Under the elastic force of the elastic membrane 302, the outer tube 200 changes with the change of the position of the fixture 102, so that the outer tube 200 slides toward the end away from the sealing component 300. At this time, the elastic membrane 302 drives the connecting rod 303 to rotate, and simultaneously drives the opening plate 301 to contract. Then, manually pull the outer tube 200 until the outer tube 200 cannot be pulled. At this time, the opening plate 301 and the elastic membrane 302 are contracted to the minimum, the rubber sleeve 201 is reset, and the excised lesion tissue is wrapped, and the entire device is slowly taken out from the cervical opening to complete the operation.

[0052] Although this specification is described according to implementation modes, not every implementation mode includes only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

[0053] Therefore, the above description is only a preferred embodiment of the present application and is not intended to limit the scope of implementation of the present application; that is, all equivalent changes made according to the scope of the claims of the present application are within the protection scope of the claims of the present application.

Claims

1. A hysteroscope water leakage prevention device, comprising an inner tube (100) and an outer tube (200), characterized in that: The inner tube (100) and the outer tube (200) are coaxially slidably connected, and the same side ends of the inner tube (100) and the outer tube (200) are connected with a sealing assembly (300), wherein the inner tube (100) is inserted into the uterine cavity and remains stationary, pushing the outer tube (200) to slide toward one end where the sealing assembly (300) is installed, so that the sealing assembly (300) opens and fits against the inner wall of the uterine cavity.

2. The hysteroscope water leakage prevention device according to claim 1, characterized in that: The sealing assembly (300) comprises a plurality of open plates (301), and elastic membranes (302) are fixedly connected between adjacent open plates (301).

3. The hysteroscope water leakage prevention device according to claim 2, characterized in that: A rubber sleeve (201) is fixed to one end of the outer tube (200), and the same side ends of the opening plate (301) and the elastic membrane (302) are fixed to one side of the rubber sleeve (201).

4. The hysteroscope water leakage prevention device according to claim 1, characterized in that: A tapered insertion end (110) is fixed at one end of the inner tube (100).

5. The hysteroscope water leakage prevention device according to claim 4, characterized in that: A fixing ring (101) is fixed at the connection between the insertion end (110) and the inner tube (100), and a connecting rod (303) is rotatably connected between the fixing ring (101) and the opening plate (301).

6. The hysteroscope water leakage prevention device according to claim 1, characterized in that: The outer side of the inner tube (100) is threadedly connected with a fixer (102).

7. The method for using the hysteroscope water leakage prevention device according to any one of claims 1 to 6, characterized in that: The following steps are involved: S1. After the cervix is ​​softened, the insertion end (110) is inserted into the cervical opening; S2, rotating the fixator (102) to make it fit the outer tube (200), pushing the outer tube (200) upward, and the opening plate (301) and the elastic membrane (302) are opened and fit the inner wall of the cervix, and the uterine cavity surgery is performed; S3, after the operation is completed, the fixator (102) is rotated in the opposite direction, the outer tube (200) is moved downward, and the plate (301) and the elastic membrane (302) are opened to reposition and wrap the excised lesion tissue; S4, separate the fixator (102) and the outer tube (200), pull the outer tube (200) to the limit position, and then remove the entire device from the cervical os.